A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Bristol-Myers Squibb

Official Title of Study: 
AA Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent 
Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT 
Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally Advanced 
Non-small Cell Lung Cancer (LA NSCLC) 
 
NCT Number: NCT04026412 
Document Date (Date in which document was last revised): 30 Oct 2023 

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Protocol Number: CA20973L 
IND: 125,872 
EU Trial Number: 2022-502886-71-00 
NCT: NCT04026412 
WHO: U1111-1229-7290 
Date: 26-Apr-2019 
Revised Date: 30-Oct-2023 
 
 
CLINICAL PROTOCOL CA20973L 
A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus Concurrent 
Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or Nivolumab plus CCRT 
Followed by Nivolumab vs CCRT followed by Durvalumab in Previously Untreated, Locally 
Advanced Non-small Cell Lung Cancer (LA NSCLC) 
(CheckMate 73L, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 73L) 
Protocol Amendment Number: 03 
Incorporates Administrative Letters: 06 and 07 
 
Clinical Trial Physician - Medical Monitor 
Clinical Scientist 
3401 Princeton Pike 
3401 Princeton Pike 
Lawrenceville, NJ 08648 
 
Lawrenceville, NJ 08648 
Phone (office): 
Phone (office): 
email: 
email: 
 
24-hr Emergency Telephone Number 
USA: 
International: 
 
Bristol-Myers Squibb Research and Development 
3401 Princeton Pike 
Lawrenceville, NJ 08648 
Avenue de Finlande 4 
B-1420 Braine-l’Alleud, Belgium 
 
This document is the confidential and proprietary information of Bristol-Myers Squibb 
Company and its global affiliates (BMS). By reviewing this document, you agree to keep it 
confidential and to use and disclose it solely for the purpose of assessing whether your 
organization will participate in and/or the performance of the proposed BMS sponsored 
study. Any permitted disclosures will be made only on a confidential "need to know" basis 
within your organization or to your independent ethics committee(s). Any other use, copying, 
disclosure or dissemination of this information is strictly prohibited unless expressly 

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authorized in writing by BMS. Any supplemental information (eg, amendments) that may 
be added to this document is also confidential and proprietary to BMS and must be kept in 
confidence in the same manner as the contents of this document. Any person who receives 
this document without due authorization from BMS is requested to return it to BMS or 
promptly destroy it. All other rights reserved. References to BMS in this protocol may apply 
to partners to which BMS has transferred obligations, eg, a Contract Research Organization 
(CRO). 

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DOCUMENT HISTORY 
 
Document 
Date of 
Issue 
Summary of Change 
Protocol 
Amendment 03 
30-Oct-2023 
• 
• 
Introduction of estimands framework per International Council on 
Harmonisation (ICH) E9 addendum. 
• 
Clarifications of language and editorial changes. 
• 
Incorporates Administrative Letters 06 and 07. 
• 
Replaced text within the CA20973L protocol to comply with EU 
Clinical Trial Regulation. 
Administrative 
Letter 07 
12-Sep-2023 
• 
The purpose of this administrative letter is to advise of a change in 
study personnel. 
Administrative 
Letter 06 
08-Dec-2021 
• 
Corrected error in Section 6.1.1. 
Protocol 
Amendment 02 
16-Aug- 
2021 
• 
Progression-free survival (PFS) statistical assumption and accrual 
duration updated based on emerging data external to the study. 
• 
Added interim analyses of PFS. 
• 
Moved overall survival for Arm A vs Arm C from a primary 
endpoint to a key secondary endpoint. 
• 
Number of tumor tissue slides requested at screening reduced from 
15 to 5-10. 
• 
Updated text throughout the document to improve alignment across 
protocol sections and/or clarify expectations for eligibility, 
assessments, sample collections, treatment administration, and to 
incorporate country-specific 
feedback. 
• 
Incorporates Administrative Letter 03. 
Administrative 
Letter 03 
20-Apr-2020 
• 
Clarification to planned chemotherapy regimen. 
• 
Clarification to Table 7-1, footnote b. 
Revised Protocol 01 
04-Mar- 
2020 
• 
Added carboplatin + paclitaxel as an additional chemotherapy option 
during CCRT. 
• 
Added the option for Cycle 1 of the CCRT Period (systemic anticancer 
therapy alone) to be skipped if RT planning is complete prior to the 
start of Cycle 1 therapy. In such cases, participants will initiate 
treatment with concurrent RT and systemic anticancer therapy 
(starting at Cycle 2 of the CCRT Period). 
• 
Revised PD-L1 stratification to include 3 separate PD-L1 strata: ≥1%, 
<1%, and indeterminate or not evaluable. In the original protocol, PD- 
L1 indeterminate or not evaluable participants were included in the 
<1% subgroup. 

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Document 
Date of 
Issue 
Summary of Change 
• 
Updated secondary endpoints to include PFS, ORR, CR rate, TTR and 
DoR per Investigator assessment. 
• 
Updated TTDM endpoint to be evaluated per Investigator assessment 
of images per RECIST 1.1. In the original protocol, TTDM was per 
BICR assessment of tumor images. 
• 
Specified that the planned chemotherapy regimen, the planned number 
of cycles of chemotherapy (up to 2 cycles or up to 3 cycles), the 
planned dose level of chemotherapy at the start of treatment for agents 
with more than 1 possible dose level per protocol (eg, carboplatin, 
paclitaxel), and the radiation modality must be pre-defined and 
documented in the IRT and medical records by the investigator prior 
to randomization. 
• 
Clarified that at Screening, a separate contrast enhanced CT of chest, 
CT or MRI of upper abdomen (including adrenal glands and full liver), 
and other suspected sites of disease is required if the CT component of 
the Screening PET/CT is not of sufficient diagnostic quality for 
RECIST 1.1 assessments. 
• 
Clarified that tumor imaging must continue until BICR confirmed 
disease progression, Investigator-assessed distant metastases, or 
treatment discontinuation due to additional PD during treatment 
beyond progression, whichever occurs later. 
• 
Added additional clinical background and updates for the NICOLAS 
and Checkmate 227 trials. 
• 
Revised CCRT inclusion criteria 1, 2 and 3; and maintenance inclusion 
criterion 5. 
• 
Revised CCRT exclusion criteria 1, 2 and 5; and maintenance 
exclusion criterion 7. 
• 
Added additional instructions for CCRT and imaging. 
• 
• 
Incorporated requests from local 
reviews of original 
protocol. 
Updated document with Administrative Letter 01 and 02 changes. 
Administrative 
Letter 02 
14-Jan-2020 
• 
Clarified the intent of CCRT Exclusion criteria 2f. 
Administrative 
Letter 01 
27-Jun-2019 
• 
Clarified that legal authorized representative (LAR) will be allowed. 
• 
To allow EGFR test performed by central lab. 
• 
• 
Corrected typographic errors for the protocol consistency. 
• 
To correct spelling errors in the protocol. 
Original Protocol 
26-Apr-2019 
Not applicable 

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OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03: 
 
Protocol revisions are specified below and have also been incorporated into the Protocol Summary 
(Synopsis). Approved administrative letter changes have also been incorporated in this protocol 
amendment, but not noted in the table below. 
 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & Title 
Description of Change 
Brief Rationale 
Title Page 
• 
EudraCT number replaced by 
European Union (EU) trial number. 
• 
Clinical Trial Physician contact 
personnel updated. 
• 
Applied the new 
administrative reference to 
comply with EU Clinical Trial 
Regulation (EU CTR), 
following the transition to 
EU CTR. 
• 
Change in personnel. 
Table 2-1: Screening Procedural 
Outline - All Study Arms (Arm 
A, Arm B, and Arm C) for 
CA20973L 
• 
Updated “within 28 days of” to 
“within 28 days prior to” for brain 
imaging assessment notes. 
• 
To clarify brain imaging 
should be performed 28 days 
prior to randomization and 
does not include the day of 
randomization. 
Section 4.1: Estimand for 
Primary Objective 
Table 4.1-1: Summary of 
Attributes of the Main Estimand 
for Primary Objective 
Table 4.1-2: Summary of 
Attributes of the Supplemental 
Estimand for Primary Objective 
Section 4.2: Estimand for Key 
Secondary Objective 
Table 4.2-1: Summary of 
Attributes of the Main Estimand 
for Secondary Objective (Arm A 
vs Arm C) 
Table 4.2-2: Summary of 
Attributes of the Main Estimand 
for Secondary Objective (Arm B 
vs Arm C) 
• 
Added new sections and tables. 
• 
To define the methods of 
comparing population 
treatment effect outcomes in 
the same participants under 
different treatment conditions 
as required per International 
Council on Harmonisation 
(ICH) E9 addendum. 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 6.1.1: Inclusion Criteria 
for CCRT 
• 
Updated 
“legal 
acceptable 
representatives (LAR)” to “legally 
acceptable representatives (LAR).” 
• 
Additional language was 
added to align with current 
Bristol-Myers Squibb 
Company (BMS) protocol 
model document (PMD). 
Section 7.7.2: Prior and 
Concomitant Medications 
• 
Clarified 
documentation 
of 
medications used for procedures 
(eg, biopsy) is encouraged. 
• 
To clarify medications used 
for procedures are encouraged 
but not required to be 
reported. 
Section 7.8: Treatment After the 
End of the Study 
• 
Additional text regarding rights for 
which the study treatment could be 
terminated has been added to align 
with current BMS PMD. 
• 
To clarify that treatment after 
end of study will be based on 
local regulations. 
Section 8.3: Lost to Follow-Up 
• 
Additional mandatory text added for 
section. 
• 
Additional language was added 
to align with current mandatory 
language in BMS PMD. 
Section 9.2.4: Regulatory 
Reporting Requirements for 
SAEs 
Appendix 2: Study Governance 
Considerations 
• 
Updated “European Directive 
2001/20/EC” to “Regulation EU 
No. 536/2014” in each respective 
section. 
• 
To 
state 
the 
new 
legal 
framework in the EU after 
transition to EU CTR. 
Section 9.2.5: Pregnancy 
• 
Additional mandatory language 
regarding pregnancy reporting has 
been added. 
• 
Additional language was 
added to align with current 
BMS PMD. 
Section 10.1: Sample Size 
Determination 
• 
Added language related to the 
discontinuation of the study within 
Russia. 
• 
To provide an update on 
BMS’ decision to discontinue 
the study in Russia and the 
inclusion of Russian study 
participants in the primary 
analysis. 

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SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03 
Section Number & Title 
Description of Change 
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 2: Study Governance 
Considerations 
• 
Added 2 new sections: BMS 
Commitment to Diversity in Clinical 
Trials and Data Protection, Data 
Privacy, and Data Security. 
• 
Added to align with BMS 
commitment to diversity in 
clinical trials and to comply 
with EU CTR requirements. 
Appendix 9: Country-specific 
Requirements for HIV Testing 
• 
Removed Germany and France 
specific requirements from 
Appendix 9. 
• 
EU-specific protocol 
amendment 01 has already 
consolidated EU 
country-specific differences. 
Appendix 10: Country-specific 
Requirements for Imprisonment 
• 
Removed from Appendices. 
• 
EU-specific protocol 
amendment 01 has already 
consolidated these 
country-specific requirements. 
All 
• 
Minor typographic and formatting 
errors. 
• 
Minor; therefore, have not 
been summarized. 

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TABLE OF CONTENTS 
TITLE PAGE ................................................................................................................ 
1 
DOCUMENT HISTORY.............................................................................................. 
3 
OVERALL RATIONALE FOR PROTOCOL AMENDMENT 03: ............................ 
5 
SUMMARY OF CHANGES FOR PROTOCOL AMENDMENT 03 ......................... 
5 
TABLE OF CONTENTS.............................................................................................. 
8 
1 SYNOPSIS................................................................................................................. 
13 
2 SCHEDULE OF ACTIVITIES.................................................................................. 
19 
3 INTRODUCTION ..................................................................................................... 
64 
3.1 Study Rationale ................................................................................................. 
65 
3.1.1 Research Hypothesis ................................................................................ 
65 
3.2 Background ....................................................................................................... 
66 
3.2.1 Epidemiology/Indication.......................................................................... 
66 
3.2.2 Mechanism of Action................................................................................ 
66 
3.2.2.1 Ipilimumab Mechanism of Action ................................................... 
66 
3.2.2.2 Nivolumab Mechanism of Action .................................................... 
67 
3.2.2.3 Clinical Experience with Nivolumab in NSCLC ............................. 
67 
3.2.3 Clinical Experience with Nivolumab plus Ipilimumab Combination 
Therapy ....................................................................................................... 
68 
3.2.4 Clinical Experience with Nivolumab and CCRT ..................................... 
70 
3.3 Benefit/Risk Assessment .................................................................................. 
71 
4 OBJECTIVES, ENDPOINTS, AND ESTIMANDS ................................................. 
72 
4.1 Estimand for Primary Objective ....................................................................... 
74 
4.2 Estimand for Key Secondary Objective............................................................ 
76 
5 STUDY DESIGN....................................................................................................... 
77 
5.1 Overall Design .................................................................................................. 
77 
5.1.1 Screening Period...................................................................................... 
79 
5.1.2 CCRT Period............................................................................................ 
80 
5.1.3 Recovery Period....................................................................................... 
82 
5.1.4 Maintenance Period................................................................................. 
82 
5.1.5 Follow Up Period .................................................................................... 
83 
5.1.6 Optional Retreatment during Follow-up Period in Arm A and Arm B.... 
84 
5.1.7 Data Monitoring Committee and Other External Committees ................ 
84 
5.1.7.1 Data Monitoring Committee ........................................................... 
84 
5.1.8 Radiotherapy Quality Assurance and Quality Control............................ 
85 
5.2 Number of Participants ..................................................................................... 
85 
5.3 End of Study Definition .................................................................................... 
85 
5.4 Scientific Rationale for Study Design............................................................... 
85 
5.4.1 Rationale for Study Population and Study Comparator .......................... 
85 
5.4.2 Rationale of Combining Nivolumab with CCRT...................................... 
86 
5.4.3 Rationale of Incorporating Ipilimumab into Radiotherapy-based Strategy 
..................................................................................................................... 
86 
5.4.4 Rationale of Concurrent Scheduling of Nivolumab with CCRT .............. 
87 
5.4.5 Rationale of Duration of Maintenance Therapy ...................................... 
87 
5.4.6 Rationale of Backbone CCRT .................................................................. 
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5.4.7 Rationale for Open-Label Design ............................................................ 
5.5 Justification for Dose ........................................................................................ 
5.5.1 Justification for Dosing Regimen of Nivolumab ...................................... 
5.5.2 Justification for Dosing Regimen of Nivolumab plus Ipilimumab........... 
6 STUDY POPULATION ............................................................................................ 
6.1 Inclusion Criteria .............................................................................................. 
6.1.1 Inclusion Criteria for CCRT .................................................................... 
6.1.2 Inclusion Criteria for Maintenance Treatment ........................................ 
6.2 Exclusion Criteria ............................................................................................. 
6.2.1 Exclusion Criteria for CCRT ................................................................... 
6.2.2 Exclusion Criteria for Maintenance ........................................................ 
6.3 Lifestyle Restrictions ........................................................................................ 
6.4 Screen Failures.................................................................................................. 
6.4.1 Retesting During Screening Period ......................................................... 
7 TREATMENT ........................................................................................................... 
7.1 Treatments Administered.................................................................................. 
7.1.1 Nivolumab Dosing ................................................................................... 
7.1.2 Ipilimumab Dosing................................................................................... 
7.1.3 Durvalumab Dosing................................................................................. 
7.1.4 Chemotherapy Dosing ............................................................................. 
7.1.4.1 Paclitaxel/Carboplatin Dosing ....................................................... 
7.1.4.2 Etoposide/cisplatin.......................................................................... 
7.1.4.3 Pemetrexed/cisplatin....................................................................... 
7.1.4.4 Carboplatin Dosing (with Etoposide or Pemetrexed) .................... 
7.1.4.5 Premedication ................................................................................. 
7.1.5 Radiotherapy Planning and Delivery ...................................................... 
7.2 Method of Treatment Assignment .................................................................... 
7.3 Blinding............................................................................................................. 
7.4 Dosage Modification......................................................................................... 
7.4.1 Nivolumab Dose Delay Criteria .............................................................. 
7.4.1.1 Criteria to Resume Nivolumab........................................................ 
7.4.2 Ipilimumab Dose Delay Criteria ............................................................. 
7.4.2.1 Criteria to Resume Ipilimumab....................................................... 
7.4.3 Dose Delay Criteria for Durvalumab ...................................................... 
7.4.4 Rescheduling Nivolumab and Ipilimumab for Arm A Maintenance 
Period: ........................................................................................................ 
7.4.4.1 Management Algorithms for Ipilimumab, Nivolumab, or 
Durvalumab .......................................................................................... 
7.4.4.2 Treatment of Nivolumab or Ipilimumab Infusion Reactions........... 
7.4.5 Chemotherapy Dose Delay, Dose Modification, and Criteria to Resume 
Treatment .................................................................................................... 
7.4.5.1 Etoposide or Pemetrexed + Platinum Regimens ............................ 
7.4.5.2 Paclitaxel + Carboplatin Regimen ................................................. 
7.4.5.3 Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose 
Modifications for Hematologic Toxicity ............................................... 
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7.4.5.4 Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose 
Modifications for Hepatic Toxicity ....................................................... 
7.4.5.5 Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose 
Modifications for Renal toxicity............................................................ 
7.4.5.6 Other toxicities with Cisplatin/Carboplatin + Etoposide or 
Pemetrexed............................................................................................ 
7.4.5.7 Dose Modifications for Toxicities with Carboplatin + Paclitaxel 
Regimen................................................................................................. 
7.4.6 Radiotherapy Dose Modification ............................................................. 
7.4.6.1 Esophagitis from Radiotherapy ...................................................... 
7.4.6.2 Pulmonary Toxicity from Radiotherapy.......................................... 
7.4.6.3 Skin Toxicity from Radiotherapy .................................................... 
7.4.6.4 Combined Chemoradiotherapy Dose Modifications ...................... 
7.5 Preparation/Handling/Storage/Accountability .................................................. 
7.6 Treatment Compliance...................................................................................... 
7.7 Concomitant Therapy........................................................................................ 
7.7.1 Prohibited and/or Restricted Treatments................................................. 
7.7.2 Prior and Concomitant Medications ....................................................... 
7.7.3 Other Restrictions and Precautions......................................................... 
7.7.4 Imaging Restriction and Precaution ........................................................ 
7.8 Treatment After the End of the Study............................................................... 
8 DISCONTINUATION CRITERIA ........................................................................... 
8.1 Discontinuation from Study Treatment ............................................................ 
8.1.1 Discontinuation Criteria for Nivolumab.................................................. 
8.1.2 Ipilimumab Discontinuation Criteria ...................................................... 
8.1.3 Durvalumab Discontinuation Criteria..................................................... 
8.1.4 Discontinuation Criteria for Chemoradiotherapy ................................... 
8.1.5 Multimodality in CCRT Period Discontinuation Criteria ....................... 
8.1.6 Treatment beyond Progression ................................................................ 
8.2 Discontinuation from the Study ........................................................................ 
8.2.1 Post Study Treatment Follow-up ............................................................. 
8.3 Lost to Follow-Up............................................................................................. 
9 STUDY ASSESSMENTS AND PROCEDURES..................................................... 
9.1 Efficacy Assessments........................................................................................ 
9.1.1 Imaging Assessment for the Study............................................................ 
9.1.1.1 Methods of Measurement ................................................................ 
9.1.1.2 Clinical Assessment and Imaging ................................................... 
9.1.1.3 BICR Confirmation of Progression or Recurrence ........................ 
9.1.2 Outcomes Research Assessments ............................................................. 
9.1.2.1 FACT-L ........................................................................................... 
9.1.2.2 Non-Small Cell Lung Cancer Symptom Assessment Questionnaire 
(NSCLC-SAQ) ....................................................................................... 
9.1.2.3 EQ-5D-5L ....................................................................................... 
9.1.2.4 Patient Global Impression of Severity (PGI-S) .............................. 
9.2 Adverse Events ................................................................................................. 
9.2.1 Time Period and Frequency for Collecting AE and SAE Information .... 
 
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9.2.2 Method of Detecting AEs and SAEs......................................................... 
9.2.3 Follow-up of AEs and SAEs ..................................................................... 
9.2.4 Regulatory Reporting Requirements for SAEs......................................... 
9.2.5 Pregnancy ................................................................................................ 
9.2.6 Laboratory Test Result Abnormalities ..................................................... 
9.2.7 Potential Drug Induced Liver Injury (DILI) ............................................ 
9.2.8 Other Safety Considerations .................................................................... 
9.2.8.1 Immune-mediated Adverse Events .................................................. 
9.3 Overdose ........................................................................................................... 
9.4 Safety ................................................................................................................ 
9.4.1 Physical Examinations............................................................................. 
9.4.2 Vital Signs ................................................................................................ 
9.4.3 Electrocardiograms ................................................................................. 
9.4.4 Clinical Safety Laboratory Assessments .................................................. 
9.4.5 Imaging Safety Assessment ...................................................................... 
9.5 Pharmacokinetics .............................................................................................. 
9.6 Pharmacodynamics ........................................................................................... 
9.7 Pharmacogenomics ........................................................................................... 
9.8 Biomarkers ........................................................................................................ 
9.8.1 Tumor Tissue Specimens.......................................................................... 
 
9.9 Medical Resource Utilization and Health Economics ...................................... 
10 STATISTICAL CONSIDERATIONS .................................................................... 
10.1 Sample Size Determination............................................................................. 
10.1.1 Sample Size Justification for PFS .......................................................... 
10.1.2 Sample Size Justification for OS ............................................................ 
10.2 Populations for Analyses ................................................................................ 
10.3 Statistical Analyses ......................................................................................... 
10.3.1 Efficacy Analyses ................................................................................... 
10.3.2 Safety Analyses....................................................................................... 
10.3.3 Other Analyses ....................................................................................... 
10.3.4 Interim Analyses..................................................................................... 
11 REFERENCES ........................................................................................................ 
12 APPENDICES ......................................................................................................... 
APPENDIX 1 ABBREVIATIONS AND TRADEMARKS ........................................ 
APPENDIX 2 STUDY GOVERNANCE CONSIDERATIONS ................................. 
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APPENDIX 3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, EVALUATING, 
FOLLOW UP AND REPORTING......................................................................... 
APPENDIX 4 WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION..................................................................... 
APPENDIX 5 ECOG PERFORMANCE STATUS ..................................................... 
APPENDIX 6 MANAGEMENT ALGORITHMS FOR STUDIES UNDER CTCAE 
VERSION 4.0 ......................................................................................................... 
APPENDIX 7 RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS ........................ 
APPENDIX 8 SUMMARY OF RECOMMENDATIONS FOR NODAL GTV 
DELINEATION BASED ON FDG-PET–CT AND E(B)US-NA.......................... 
APPENDIX 9 COUNTRY-SPECIFIC REQUIREMENTS FOR HIV TESTING....... 
APPENDIX 10 REVISED PROTOCOL SUMMARY OF CHANGE HISTORY ...... 
 
 
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1 
SYNOPSIS 
Protocol Title: A Phase 3, Randomized, Open Label Study to Compare Nivolumab plus 
Concurrent Chemoradiotherapy (CCRT) followed by Nivolumab plus Ipilimumab or 
Nivolumab plus CCRT Followed by Nivolumab vs CCRT followed by Durvalumab in 
Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC) 
(CheckMate 73L, CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 73L) 
Study Phase: 3 
Rationale: CA20973L is a phase 3, randomized, open label study to compare nivolumab plus 
concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab or nivolumab 
alone versus concurrent chemoradiotherapy (CCRT) followed by durvalumab in previously 
untreated locally advanced non-small cell lung cancer (LA NSCLC). 
Adding anti-PD-1 treatment concurrently to CCRT is hypothesized to improve anti-tumor activity. 
Subsequently, combining immunotherapeutic agents with different mechanisms of action in the 
maintenance period following CCRT may offer the possibility of a synergistic response. PD-1 and 
CTLA-4 are both co-inhibitory molecules, but evidence suggests that they use distinct mechanisms 
to limit T cell activation. Therefore, combining anti-PD-1 and anti-CTLA-4 immunotherapies 
following CCRT has the potential to improve outcomes. 
The current study aims to demonstrate that incorporation of nivolumab to definitive CCRT, 
followed by nivolumab with/without ipilimumab will be efficacious in participants with newly 
diagnosed untreated LA NSCLC, compared with CCRT followed by durvalumab. Additional 
objectives of the study include characterization of safety and tolerability, as well as 
pharmacokinetics, 
, and changes in patient-reported outcomes for 
quality of life assessments. The safety and efficacy of ipilimumab added to nivolumab 
maintenance therapy will be characterized descriptively. 
Study Population: Previously untreated locally advanced non-small cell lung cancer (LA 
NSCLC). 
Objectives, Endpoints, and Estimands: 
The study objectives and endpoints described below will be evaluated for the following treatment 
regimens: 
• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance 
• Arm B: Nivolumab + CCRT followed by nivolumab maintenance 
• Arm C: CCRT followed by durvalumab maintenance 

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Objectives 
Endpoints 
Primary 
To compare progression-free survival (PFS) for Arm 
A vs Arm C 
• 
PFS by RECIST 1.1 per BICR 
Main Estimand for the Primary Objective: 
Stratified HR in PFS by RECIST 1.1 per BICR between Arm A and Arm C irrespective of initiation of 
subsequent anti-cancer therapy 
Secondary 
To compare OS for Arm A vs Arm C 
• 
OS for Arm A vs Arm C 
To evaluate PFS and OS for Arm B vs Arm C and 
Arm A vs Arm B 
• 
PFS by RECIST 1.1 per BICR for Arm B vs Arm C 
• 
OS for Arm B vs Arm C 
• 
PFS by RECIST 1.1 per BICR for Arm A vs Arm B 
• 
OS for Arm A vs Arm B 
To evaluate tumor response for Arm A vs Arm C, 
Arm B vs Arm C, and Arm A vs Arm B according to 
BICR assessment 
• 
Objective Response Rate (ORR) by RECIST 1.1 
per BICR 
• 
Duration of response (DoR) by RECIST 1.1 per 
BICR 
• 
Time to response (TTR) by RECIST 1.1 per BICR 
To evaluate PFS and tumor response for Arm A vs 
Arm C, Arm B vs Arm C, and Arm A vs Arm B 
according to Investigator assessment of tumor 
imaging 
• 
PFS by RECIST 1.1 per Investigator assessment 
• 
ORR by RECIST 1.1 per Investigator assessment 
• 
DoR by RECIST 1.1 per Investigator assessment 
• 
TTR by RECIST 1.1 per Investigator assessment 
To evaluate time to death or distant metastases 
(TTDM) for Arm A vs Arm C, Arm B vs Arm C, and 
Arm A vs Arm B according to Investigator 
assessment of tumor imaging 
• 
TTDM by RECIST 1.1 per Investigator assessment 
To assess safety and tolerability of study treatment 
• 
Incidence of AEs, SAEs, and select AEs 
To evaluate symptom deterioration for Arm A vs Arm 
C, Arm B vs Arm C, and Arm A vs Arm B 
• 
Proportion of participants without meaningful 
symptom deterioration following 48 weeks of 
maintenance therapy based on NSCLC-SAQ 
Main Estimand for the Secondary Objective: 
Stratified HR in OS between Arm A vs Arm C and Arm B vs Arm C 
Abbreviations: AE, adverse event; BICR, blinded independent central review; DoR, duration of response; HR, hazard 
ratio; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; ORR, objective response rate; 
OS, overall survival; PFS, progression-free survival; RECIST 1.1, Response Evaluation Criteria in Solid Tumors 
version 1.1; SAE, serious adverse event; TTDM, time to death or distant metastases; TTR, time to response. 
 
 
Overall Design: This multicenter, randomized, open label, Phase 3 study compares nivolumab 
plus CCRT followed by nivolumab and ipilimumab combination (Arm A) or nivolumab plus 
CCRT followed by nivolumab alone (Arm B) with CCRT followed by durvalumab (Arm C) in 

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previously untreated LA NSCLC. The safety and efficacy of ipilimumab added to nivolumab 
maintenance therapy will also be characterized by evaluating Arm A vs Arm B descriptively. 
The study is divided into a Screening Period, Concurrent Chemoradiotherapy (CCRT) Period, 
Recovery Period, Maintenance Period, and a Long-term Follow-up Period. The treatment period 
will contain a CCRT Period, a Recovery Period, and a Maintenance Period. Randomization will 
be stratified by: 
• Age: 
− < 65 years 
− ≥ 65 years 
• Tumor PD-L1 status 
− ≥ 1% 
− < 1% 
− indeterminate or not evaluable 
• Stage per AJCC 8th edition: 
− IIIA 
− IIIB 
− IIIC 

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Study Design Schematic 
 
Abbreviations: BICR, blinded independent central review; CCRT, concurrent chemoradiotherapy; ECOG, Eastern 
Cooperative Oncology Group; N, number of participants; NSCLC, non-small cell lung cancer; PD, progressive 
disease; PD-L1, programmed death-ligand 1; PFS, progression-free survival; Q2W, every 2 weeks; Q3W, every 3 
weeks; Q4W, every 4 weeks; Q6W, every 6 weeks; R, randomize; RT, radiotherapy. 
 
 
Number of Participants: Assuming approximately a 40% screen failure rate, approximately 
1400 participants may be screened to randomize 888 participants with previously untreated locally 
advanced NSCLC (1:1:1) to the 3 treatment arms. 
Treatment Arms and Duration: Participants will be randomized (1:1:1) across the 3 treatment 
arms: 
• Arm A: 
− CCRT Period: Nivolumab (360 mg flat dose IV Q3W) for cycles 1 to 3 + platinum doublet 
chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy (total dose of 60-66 Gy) for 
cycles 2 to 3 
− Maintenance Period: Nivolumab (360 mg flat dose IV Q3W) + ipilimumab (1 mg/kg IV 
Q6W) for up to 12 months 

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• Arm B: 
− CCRT Period: Nivolumab (360 mg flat dose IV Q3W) for cycles 1 to 3 + platinum doublet 
chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy (total dose of 60-66 Gy) for 
cycles 2 to 3 
− Maintenance Period: Nivolumab (480 mg flat dose IV Q4W) for up to 12 months 
• Arm C: 
− CCRT Period: Platinum doublet chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy 
(total dose of 60-66 Gy) for cycles 2 to 3 
− Maintenance Period: Durvalumab (10 mg/kg IV Q2W) for up to 12 months. 
 
If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 
of the CCRT Period (Arms A, B, or C), the investigator has the option to skip Cycle 1 of systemic 
anticancer therapy alone, and initiate treatment with radiotherapy concurrently with systemic 
anticancer therapy (Cycle 2). All study procedures for Cycle 2 and Cycle 3 during the CCRT 
Period are still to be followed. The Recovery Period will begin after the final dose of radiotherapy 
and the completion of Cycle 3 procedures as outlined in the Schedule of Activities. An additional 
cycle of consolidation chemotherapy + nivolumab (Arms A and B) or chemotherapy alone 
(Arm C) will not be administered after the completion of radiotherapy in this situation. 

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Study Drugs for CA20973L 
Medication 
Potency 
IP/Non-IP 
Ipilimumab Solution for Injection 
200 mg (5 mg/mL) 
IP 
Ipilimumab Solution for Injectiona 
50 mg (5 mg/mL) 
IP 
Nivolumab Solution for Injectionb 
100 mg (10 mg/mL) 
IP 
Cisplatin Solution for Infusionc 
100 mg/vial (1 mg/mL) 
IP 
Etoposide Concentrate for Solution for Injectionc 
100 mg/vial (20 mg/mL) 
IP 
Durvalumab Solution for Injectionc 
500 mg/vial (50 mg/mL) 
IP 
Carboplatin Solution for Injectionc 
450 mg/vial (10 mg/mL) 
IP 
Pemetrexed Powder for Concentrate for Solution for Infusionc 
500 mg/vial 
IP 
Paclitaxel Solution for Infusionc 
100 mg/vial (6 mg/mL) 
IP 
Abbreviations: IP, investigational product; SmPC, Summary of Product Characteristics. 
a 50 mg ipilimumab vial will be available starting Q3 2022 and may be used in this study. 
b May be labeled as either “BMS-936558-01” or “Nivolumab.” 
c These products may be obtained by the investigational sites as local commercial product in certain countries if 
allowed by local regulations. In these cases, products may be a different pack size/potency than listed in the table. 
The approved local product label (including package insert, SmPC, or equivalent), or local standards for preparing 
and administering these agents may be used, as long as there is no change in the treatment dose or administrative 
schedule, as specified in the protocol. 
 
 
Data Monitoring Committee: Yes 

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2 
SCHEDULE OF ACTIVITIES 
Table 2-1: 
Screening Procedural Outline - All Study Arms (Arm A, Arm B, and Arm C) for CA20973L 
 
Procedure 
Screening 
Visit 
Notes (28 day window, unless specified otherwise)a 
Eligibility Assessments 
Informed Consent 
X 
Register in Interactive Response Technology (IRT) to obtain participant number at the time informed 
consent is obtained. 
Must be obtained prior to performing any protocol-specific screening procedures. 
Study allows for re-enrollment of a participant that has discontinued the study as a pre-treatment failure. 
If re-enrolled, the participant must be re-consented and assigned a new participant number from IRT. 
Inclusion/Exclusion Criteria 
X 
Must be confirmed prior to randomization. 
Medical History 
X 
All medical history relevant to the disease under study including smoking history, alcohol use, AJCC 
stage (per 8th edition), histology, and other relevant history. 
Participants must be evaluated by the site’s multidisciplinary team (eg, medical oncologist, surgeon, 
radiologist) during screening to assess suitability of participant for the study. 
Tumor Sample Submission 
X 
All participants must have tumor tissue available, either recent archival sample (obtained within 3 months 
prior to enrollment) or a fresh pre-treatment biopsy obtained during the Screening Period. 
Sufficient tissue including 1 FFPE tumor block (preferred) or 5-10 unstained slides must be submitted to 
the central laboratory for PD-L1 testing. 
The central laboratory must provide IRT with PD-L1 status prior to randomization. See Section 6.1.1 for 
additional requirements. 
Lymph Node Sampling 
X 
Except for overt cT4 disease, nodal status N2 or N3 must be proven (by biopsy in at least one N2 or N3 
node) via endobronchial ultrasound (EBUS), mediastinoscopy, or thoracoscopy. In addition, T3N1 status 
must be proven in at least one N1 node, if lesion amenable or medically feasible, via one of these 
modalities. Sample collected prior to screening is acceptable. 
See Section 6.1 for additional requirements. 
See Appendix 8 for summary for recommendations for nodal GTV delineation. 
Safety Assessments 
Physical Examination (PE), 
Physical Measurements, and Vital 
Signs 
X 
Height, weight, and vital signs (BP, HR, and temperature) must be collected within 14 days prior to 
randomization. 

Clinical Protocol 
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Table 2-1: 
Screening Procedural Outline - All Study Arms (Arm A, Arm B, and Arm C) for CA20973L 
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Procedure 
Screening 
Visit 
Notes (28 day window, unless specified otherwise)a 
ECOG Performance Status 
X 
Within 14 days prior to randomization (See Appendix 5) 
Assessment of Signs and Symptoms 
X 
Must be performed within 14 days prior to randomization. 
Concomitant Medication Use 
X 
Must be collected within 14 days prior to randomization. Document vaccine use within 30 days prior to 
randomization. See Section 7.7. 
Serious Adverse Events Assessment 
X 
Serious Adverse Event collection from time of consent. 
All AEs (SAEs or non-serious AEs) associated with SARS-CoV-2 infection collected from time of 
consent. 
ECG 
X 
Must be performed within 14 days prior to randomization. See Section 9.4.3. 
Pulmonary function tests 
X 
FEV1, DLCO (%) within 42 days prior to randomization 
Laboratory Tests 
Clinical Laboratory Testing 
X 
All laboratory assessments to be performed within 14 days prior to randomization, except for viral testing 
which is to be completed within 28 days prior to randomization. 
See Table 9.4.4-1 for clinical safety laboratory assessments. 
Pregnancy Test, Follicle 
Stimulating Hormone Test (FSH) 
X 
Serum or urine test (minimum sensitivity 25 IU/L or equivalent units of HCG) to be done at Screening in 
women of childbearing potential (WOCBP). 
Follicle stimulating hormone (FSH) screening - only required to confirm menopause in women <55 years 
of age. 
EGFR Mutation 
X 
EGFR mutation status required for all non-squamous participants (tumor tissue or blood-based assay). 
Historical results obtained as standard of care prior to Screening Period are acceptable. 
Testing to be performed locally or centrally. An approved test by local Health Authority is recommended. 
If mutation testing will be performed centrally, 5 FFPE tumor slides will need to be submitted to the 
central lab in addition to the 5-10 tumor slides required for PD-L1 testing. 

Clinical Protocol 
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nivolumab 
Table 2-1: 
Screening Procedural Outline - All Study Arms (Arm A, Arm B, and Arm C) for CA20973L 
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Procedure 
Screening 
Visit 
Notes (28 day window, unless specified otherwise)a 
Tumor Assessments 
See Section 9.1 
Body Imaging 
X 
PET/CT Whole Body, including contrast, of the base of skull through the upper thighs within 28 days 
prior to randomization. PET component can be performed within 42 days prior to randomization. A 
separate contrast enhanced CT of chest, CT or MRI of upper abdomen (including adrenal glands and full 
liver), and other suspected sites of disease is required if the CT component of the PET/CT is not of 
sufficient diagnostic quality for RECIST 1.1 assessments. 
Participants must have measurable disease per RECIST 1.1 criteria as assessed by investigator. TNM 
staging according to AJCC 8th edition. 
See Section 9.1.1 for further details. 
Brain Imaging 
X 
Within 28 days prior to randomization, MRI of the brain without and with contrast is required for ALL 
participants during screening to rule out brain metastases. 
CT of the brain (without and with contrast) can be performed if MRI is contraindicated or based on 
Investigator discretion. See Section 9.1.1 for further details. 
Abbreviations: AE, adverse event; AJCC, American Joint Committee on Cancer; BP, blood pressure; CRF, case report form; CT, computed tomography; DLCO, 
diffusing capacity of the lungs for carbon monoxide; EBUS, endobronchial ultrasound; ECG, electrocardiogram; ECOG, Eastern Cooperative Oncology Group; 
EGFR, epidermal growth factor receptor; FEV1, forced expiratory volume during first second of forced breath; FFPE, formalin-fixed paraffin-embedded; FSH, 
follicle-stimulating hormone; GTV, gross tumor volume; HCG, human chorionic gonadotropin; 
; IRT, Interactive Response Technology; 
MRI, magnetic resonance imaging; PD-L1, programmed death-ligand 1; PE, physical examination; PET, positron emission tomography; RECIST 1.1, Response 
Evaluation Criteria in Solid Tumors version 1.1; SAE, serious adverse event; 
 
; TNM, tumor nodal 
metastasis; WOCBP, women of childbearing potential. 
a Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Safety Assessments 
Targeted 
Physical 
Examination, 
Weight, and 
Vital Signs 
X 
X 
X 
Weight, BP, HR, and temperature before 
treatment on D1 of each cycle. 
Weight can be assessed up to 24 hours prior to 
dosing. 
ECOG 
Performance 
Status 
X 
X 
X 
Prior to treatment on D1 of each cycle. See 
Appendix 5 
Adverse Events 
Assessment 
(including 
Serious Adverse 
Events) 
Continuously 
All AEs (SAEs or non-serious AEs), including 
those associated with SARS-CoV-2 infection, 
must be collected continuously during the 
treatment period. 
Record at each visit. Collect continuously 
throughout the CCRT Period. 
See Section 9.2.1 for the timing of AE/SAE 
collection. 
Concomitant 
Medication Use 
Continuously 
Record at each visit. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Laboratory Tests 
Clinical 
Laboratory 
Testing 
X 
X 
X 
Within 72 hrs prior to dosing. 
Note: C1D1 labs (or C2D1 labs for 
participants who skip cycle 1; see footnote a) 
do not need to be repeated if performed at 
screening within 72 hours prior to the start of 
treatment. See Table 9.4.4-1 for clinical safety 
laboratory assessments. 
Thyroid 
Stimulating 
Hormone 
X 
X 
X 
TSH (with reflexive fT3 and fT4 if TSH is 
abnormal) must be performed within 72 hrs 
prior to D1 of every cycle except for Arm C 
in the CCRT period. Note: C1D1 labs (or 
C2D1 labs for participants who skip C1; see 
footnote a) do not need to be repeated if 
performed at screening within 72 hours prior 
to the start of treatment. For more details, see 
Table 9.4.4-1 for clinical safety laboratory 
assessments. 
Pregnancy Test 
WOCBP only 
X 
X 
X 
Serum or urine pregnancy test (minimum 
sensitivity 25 IU/L or equivalent units of 
HCG) within 24 hours prior to Day 1 of each 
cycle. 
Test must be performed at least every 4 weeks 
(± 1 week) regardless of dosing schedule in 
cases of dose delays. 

Clinical Protocol 
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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
PK/ IMG 
Assessments 
(Arm A and 
Arm B only) 
PK and immunogenicity sampling varies by cycle. See specimen collection schedule as 
specified in Arm A (CCRT) in Table 9.5-1 and Arm B (CCRT) in Table 9.5-3. 
See Section 9.5 for complete details. 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
X 
Completed prior to dosing on D1 of each 
cycle. If a dose is delayed, outcome 
assessments should also be delayed until 
dosing is resumed. 
See Section 9.1.2. 
PGI-S 
X 
X 
X 
FACT-L 
X 
X 
X 
EQ-5D-5L 
X 
X 
X 
Healthcare 
Resource 
Utilization 
(HCRU) 
X 
X 
X 
See Section 9.9. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Study Treatment 
See Section 7.1. 
Randomize 
X 
See 
note 
Up to 7 days prior to C1D1 (Note: C2D1 for 
participants who skip cycle 1; see footnote a). 
Prior to randomization, the planned 
chemotherapy regimen, the planned number 
of cycles of chemotherapy (up to 2 cycles or 
up to 3 cycles), the planned dose level of 
chemotherapy at the start of treatment for 
agents with more than 1 possible dose level 
per protocol (e.g. carboplatin, paclitaxel), and 
the radiation modality must be pre-defined 
and documented in the IRT and medical 
records by the investigator. 
Administer 
Nivolumab 
(Arm A and 
Arm B Only) 
X 
X 
X 
Participants in Arm C will not receive 
nivolumab as part of the CCRT Period 
Administer nivolumab for participants 
randomized to Arms A and B only as a flat 
dose of 360 mg IV Q3W on Day 1 of each 
cycle. 
Nivolumab must be administered prior to 
administration of chemotherapy. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Administer 
Cisplatin (or 
Carboplatin) 
(all Arms) 
X 
X 
X 
First dose of chemotherapy must be 
administered within 7 calendar days of 
randomization. 
If a participant cannot tolerate cisplatin, then 
carboplatin may be used at dose of AUC 5 IV 
Q3W on Day 1 of each cycle at the discretion 
of the investigator. 
Pre-medication prior to the chemotherapy on 
D1 of each cycle should be administered after 
the completion of nivolumab infusion (Arms 
A and B). 
Cisplatin (or carboplatin) treatment outlined 
here is for combination with pemetrexed or 
etoposide only. 
Administer 
Etoposide 
(only for 
participants 
NOT receiving 
Pemetrexed) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
For participants receiving cisplatin (or 
carboplatin) and Etoposide: 
Cisplatin must be administered as a dose of 
80 mg/m2 IV Q3W on Day 1 of each cycle. 
Etoposide must be administered as a dose of 
100 mg/m2 IV Q3W on a Day 1, Day 2, and 
Day 3 of each cycle. Days 2 and 3 may be 
interrupted, delayed, or discontinued 
depending on how well the participant 
tolerates the treatment and per investigator’s 
discretion. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Administer 
Pemetrexed 
(only for 
participants 
NOT receiving 
Etoposide) 
X 
X 
X 
For participants receiving cisplatin (or 
carboplatin) and Pemetrexed: 
Cisplatin must be administered as a dose of 
75 mg/m2 IV Q3W on Day 1 of each cycle. 
Pemetrexed must be administered with a dose 
of 500 mg/m2 IV Q3W on a Day 1 of each 
cycle. 
If a participant cannot tolerate pemetrexed, 
then etoposide may be used instead at the 
discretion of the investigator. 

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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Radiotherapy 
Radiation therapy starts on Day 1 of Cycle 2 (See note) 
Participants will receive radiotherapy for 5 days every week in daily 
fraction of 2 Gy. The total target dose will be 60-66 Gy in 
30-33 fractions 
Each participant will receive thoracic 
radiotherapy in form of IMRT, VMAT, or 
3DRT. 
The order of the treatment for D1 of C2 and 
C3 are nivolumab, followed by chemotherapy. 
It is recommended that radiotherapy be 
administered after the completion of systemic 
anti-cancer therapy and on the same day if 
logistically feasible. Otherwise, a window of 
± 3 days is permitted. 
Note: If radiotherapy planning is complete 
prior to the initiation of systemic anticancer 
therapy at Cycle 1 (Arms A, B or C), the 
Investigator has the option to skip Cycle 1 
procedures (with systemic anticancer therapy 
alone) and initiate the CCRT period with 
Cycle 2 procedures (radiotherapy concurrently 
with systemic anticancer therapy). All study 
procedures for Cycle 2 and Cycle 3 are still to 
be followed in this situation. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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Table 2-2: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All Arms 
(Arm A, Arm B, and Arm C for CA20973L) Cisplatin (or Carboplatin) + Etoposide or Pemetrexed 
Treatment Regimens 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D2 
D3 
D1 
D2 
D3 
D4 
D5 
D1 
D2 
D3 
D4 
D5 
Efficacy Assessments 
Body and/or 
Brain Imaging 
See note 
No scheduled scan until the recovery period 
but unscheduled scans are permitted per 
investigator judgment. For participants with 
progressive disease that has not been 
confirmed by BICR, if the planned start of 
subsequent anticancer therapy is sooner than 
the time of next scheduled tumor assessment, 
every effort should be made to repeat tumor 
imaging prior to initiation of subsequent 
anticancer therapy. 
Abbreviations: 3DRT, 3-dimensional radiotherapy; AE, adverse event; AUC, area under the concentration-time curve; BICR, blinded independent central review; 
BP, blood pressure; C, Cycle; CCRT, concurrent chemoradiotherapy; CRF, case report form; D, day; ECOG, Eastern Cooperative Oncology Group; EQ-5D-5L, 
5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer Therapy - Lung; 
; fT3, free 
triiodothyronine; fT4, free thyroxine; HCG, human chorionic gonadotropin; HCRU, healthcare resource utilization; HR, heart rate; IgG, immunoglobulin G; 
IMG, immunogenicity; IMRT, intensity-modulated radiation therapy; IRT, Interactive Response Technology; IV, intravenous; NSCLC-SAQ, Non-small Cell Lung 
Cancer Symptom Assessment Questionnaire; PGI-S, Patient Global Impression of Severity; PK, pharmacokinetic; Q3W, every 3 weeks; SAE, serious adverse 
event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TSH, thyroid stimulating hormone; VMAT, volumetric-modulated arc therapy; WOCBP, 
women of childbearing potential. 
a If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 of the CCRT period (Arms A, B or C), the Investigator has 
the option to skip Cycle 1 of systemic anticancer therapy alone, and initiate treatment with radiotherapy concurrently with systemic anticancer therapy (Cycle 
2). All study procedures for Cycle 2 and Cycle 3 during the CCRT period are still to be followed. The Recovery Period will begin after the final dose of 
radiotherapy and the completion of Cycle 3 procedures as outlined above. An additional cycle of consolidation chemotherapy + nivolumab (Arms A and B) or 
chemotherapy alone (Arm C) will not be administered after the completion of radiotherapy in this situation. 
b If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 

Clinical Protocol 
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CA20973L 
nivolumab 
Protocol Amendment No.: 03 
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c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
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Table 2-3: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All 
Arms (Arm A, Arm B, and Arm C for CA20973L) Carboplatin + Paclitaxel Treatment Regimen 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D1 
D8 
D15 
D1 
D8 
D15 
Safety Assessments 
Targeted PE, 
Weight, and 
Vital Signs 
X 
X 
X 
X 
X 
X 
X 
Weight, BP, HR, and temperature before 
treatment. 
Weight can be assessed up to 24 hours prior to 
dosing. 
ECOG 
Performance 
Status 
X 
X 
X 
X 
X 
X 
X 
See Appendix 5. 
Adverse Events 
Assessment 
(including 
SAEs) 
Continuously 
All AEs (SAEs or non-serious AEs), including 
those associated with SARS-CoV-2 infection, 
must be collected continuously during the 
treatment period. 
Record at each visit. Collect continuously 
throughout the CCRT Period. 
See Section 9.2.1 for the timing of AE/SAE 
collection. 
Concomitant 
Medication Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical 
Laboratory 
Testing 
X 
X 
X 
X 
X 
X 
X 
Within 72 hrs prior to dosing. 
Note: C1D1 labs (or C2D1 labs for participants 
who skip cycle 1; see footnote a) do not need to 
be repeated if performed at screening within 72 
hours prior to the start of treatment. See 
Table 9.4.4-1 for clinical safety laboratory 
assessments. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
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Table 2-3: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All 
Arms (Arm A, Arm B, and Arm C for CA20973L) Carboplatin + Paclitaxel Treatment Regimen 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D1 
D8 
D15 
D1 
D8 
D15 
Thyroid 
Stimulating 
Hormone 
X 
X 
X 
TSH (with reflexive fT3 and fT4 if TSH is 
abnormal) must be performed within 72 hrs prior 
to D1 of every cycle except for Arm C in the 
CCRT period. Note: C1D1 labs (or C2D1 labs 
for participants who skip C1; see footnote a) do 
not need to be repeated if performed at screening 
within 72 hours prior to the start of treatment. 
See Table 9.4.4-1 for clinical safety laboratory 
assessments. 
Pregnancy Test 
(WOCBP only) 
X 
X 
X 
Serum or urine pregnancy test (minimum 
sensitivity 25 IU/L or equivalent units of HCG) 
within 24 hours prior to Day 1 of each cycle. 
Test must be performed at least every 4 weeks 
(± 1 week) regardless of dosing schedule in 
cases of dose delays. 
PK/ IMG 
Assessments 
(Arm A and 
Arm B only) 
PK and immunogenicity sampling varies by cycle. See specimen collection schedule 
as specified in Arm A (CCRT) in Table 9.5-1 and Arm B (CCRT) in Table 9.5-3. 
See Section 9.5 for complete details. 

Clinical Protocol 
BMS-936558 
CA20973L 
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Protocol Amendment No.: 03 
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Table 2-3: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All 
Arms (Arm A, Arm B, and Arm C for CA20973L) Carboplatin + Paclitaxel Treatment Regimen 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D1 
D8 
D15 
D1 
D8 
D15 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
X 
Completed prior to dosing on D1 of each cycle. 
If a dose is delayed, outcome assessments 
should also be delayed until dosing is resumed. 
See Section 9.1.2. 
PGI-S 
X 
X 
X 
FACT-L 
X 
X 
X 
EQ-5D-5L 
X 
X 
X 
HCRU 
X 
X 
X 
See Section 9.9. 
Study Treatment 
See Section 7.1. 
Randomize 
X 
See 
notes 
Up to 7 days prior to C1D1 (Note: or C2D1 for 
participants who skip cycle 1; see footnote a). 
Prior to randomization, the planned chemotherapy 
regimen, the planned number of cycles of 
chemotherapy (up to 2 cycles or up to 3 cycles), 
the planned dose level of chemotherapy at the 
start of treatment for agents with more than 1 
possible dose level per protocol (e.g. 
carboplatin, paclitaxel), and the radiation 
modality must be pre-defined and documented 
in the IRT and medical records by the 
investigator. 
Administer 
Nivolumab 
(Arm A and 
Arm B Only) 
X 
X 
X 
Participants in Arm C will not receive 
nivolumab as part of the CCRT Period 
Administer nivolumab for participants 
randomized to Arms A and B only as a flat dose 
of 360 mg IV Q3W on Day 1 of each cycle. 
Nivolumab must be administered prior to 
administration of chemotherapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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Table 2-3: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All 
Arms (Arm A, Arm B, and Arm C for CA20973L) Carboplatin + Paclitaxel Treatment Regimen 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D1 
D8 
D15 
D1 
D8 
D15 
Administer 
Carboplatin 
(only when 
used in 
combination 
with 
Paclitaxel) 
X 
X 
X 
X 
X 
X 
X 
First dose of chemotherapy must be 
administered within 7 calendar days of 
randomization. Days 8 and 15 may be 
interrupted, delayed, or discontinued depending 
on how well the participant tolerates the 
treatment and per investigator’s discretion. 
Pre-medication prior to the chemotherapy on D1 
of each cycle should be administered after the 
completion of nivolumab infusion, if clinically 
feasible (Arms A and B). 
Carboplatin is to be administered as follows 
in combination with paclitaxel: 
• 
AUC 5 or 6 on Day 1 of Cycle 1 
• 
AUC 2 on Days 1, 8, and 15 of Cycle 2 and 
Cycle 3 
Administer 
Paclitaxel 
X 
X 
X 
X 
X 
X 
X 
First dose of chemotherapy must be 
administered within 7 calendar days of 
randomization. Days 8 and 15 may be 
interrupted, delayed, or discontinued depending 
on how well the participant tolerates the 
treatment and per investigator’s discretion. 
Paclitaxel is to be administered as follows in 
combination with carboplatin: 
• 
175 or 200 mg/m2 on Day 1 of Cycle 1 
• 
45 or 50 mg/m2 on Days 1, 8, and 15 of 
Cycle 2 and Cycle 3 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
35 
Approved v81.0 
930137110 8.0 
 
 
Table 2-3: 
On Study Treatment Procedural Outline – Concurrent Chemoradiotherapy (CCRT) Period – All 
Arms (Arm A, Arm B, and Arm C for CA20973L) Carboplatin + Paclitaxel Treatment Regimen 
 
Procedure 
Cycle 1a,b 
(3 weeks) 
Cycle 2a,b 
(3 weeks ± 3 days) 
Cycle 3b 
(3 weeks ± 3 days) 
Notesc 
D1 
D1 
D8 
D15 
D1 
D8 
D15 
Radiotherapy 
Radiation therapy starts on Day 1 of Cycle 2. See note. 
Participants will receive radiotherapy for 5 days every 
week in daily fraction of 2 Gy. The total target dose will 
be 60-66 Gy in 30-33 fractions 
Each participant will receive thoracic 
radiotherapy in form of IMRT, VMAT, or 
3DRT. 
The order of the treatment for D1 of C2 and C3 
are nivolumab, followed by chemotherapy. It is 
recommended that radiotherapy be administered 
after the completion of systemic anticancer 
therapy and on the same day if logistically 
feasible. Otherwise, a window of ± 3 days is 
permitted. 
Note: If radiotherapy planning is complete prior 
to the initiation of systemic anticancer therapy at 
Cycle 1 (Arms A, B or C), the Investigator has 
the option to skip Cycle 1 procedures (with 
systemic anticancer therapy alone) and initiate 
the CCRT period with Cycle 2 procedures 
(radiotherapy concurrently with systemic 
anticancer therapy). All study procedures for 
Cycle 2 and Cycle 3 are still to be followed in 
this situation. 
Efficacy Assessments 
Body and/or 
Brain Imaging 
See note. 
No scheduled scan until the recovery period but 
unscheduled scans are permitted per investigator 
judgment. For participants with progressive 
disease that has not been confirmed by BICR, if 
the planned start of subsequent anticancer 
therapy is sooner than the time of next scheduled 
tumor assessment, every effort should be made 
to repeat tumor imaging prior to initiation of 
subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
36 
Approved v81.0 
930137110 8.0 
 
 
Abbreviations: 3DRT, 3-dimensional radiotherapy; AE, adverse event; AUC, area under the concentration-time curve; BICR, blinded independent central review; 
BP, blood pressure; C, Cycle; CCRT, concurrent chemoradiotherapy; CRF, case report form; D, day; ECOG, Eastern Cooperative Oncology Group; EQ-5D-5L, 
5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer Therapy - Lung; 
fT3, free 
triiodothyronine; fT4, free thyroxine; HCG, human chorionic gonadotropin; HCRU, healthcare resource utilization; HR, heart rate; IgG, immunoglobulin G; IMG, 
immunogenicity; IMRT, intensity-modulated radiation therapy; IRT, Interactive Response Technology; IV, intravenous; NSCLC-SAQ, Non-small Cell Lung 
Cancer Symptom Assessment Questionnaire; PE, physical examination; PGI-S, Patient Global Impression of Severity; PK, pharmacokinetic; Q3W, every 3 weeks; 
SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; TSH, thyroid stimulating hormone; VMAT, volumetric-modulated 
arc therapy; WOCBP, women of childbearing potential. 
a If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 of the CCRT period (Arms A, B or C), the Investigator has 
the option to skip Cycle 1 of systemic anticancer therapy alone, and initiate treatment with radiotherapy concurrently with systemic anticancer therapy (Cycle 
2). All study procedures for Cycle 2 and Cycle 3 during the CCRT period are still to be followed. The Recovery Period will begin after the final dose of 
radiotherapy and the completion of Cycle 3 procedures as outlined above. An additional cycle of consolidation chemotherapy + nivolumab (Arms A and B) or 
chemotherapy alone (Arm C) will not be administered after the completion of radiotherapy in this situation. 
b If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 
c Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-4: 
On Study Treatment Procedural Outline – Recovery Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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Procedure 
Recovery Period 
Notes 
Week 3 of Recovery Period 
Day 22 post CCRT 
End of Recovery 
Perioda 
Safety Assessments 
Targeted PE, Weight, 
and Vital Signs 
X 
X 
Weight, BP, HR, and temperature 
ECOG Performance 
Status 
X 
X 
See Appendix 5. 
ECG 
X 
Adverse Events 
Assessment 
(including SAEs) 
Continuously 
All AEs (SAEs or non-serious AEs), including those associated with 
SARS-CoV-2 infection, must be collected continuously during the 
recovery period. 
Record at each visit. Collect continuously throughout the Recovery 
Period. See Section 9.2. 
Concomitant Medication 
Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical Laboratory 
Testing 
X 
X 
Hematology and chemistry testing should be collected during Recovery 
Period and before maintenance treatment. All testing results during the 
Recovery Period should be documented. See Table 9.4.4-1 for clinical 
safety laboratory assessments. 
Pregnancy Test 
(WOCBP only) 
See notes 
Serum or urine pregnancy test must be performed at least every 4 weeks 
(± 1 week) during Recovery Period. 
Eligibility Criteria before 
Entering the 
Maintenance Period 
X 
See Section 6.1.2 and Section 6.2.2. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-4: 
On Study Treatment Procedural Outline – Recovery Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
38 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Recovery Period 
Notes 
Week 3 of Recovery Period 
Day 22 post CCRT 
End of Recovery 
Perioda 
Efficacy Assessments 
Body Imagingb 
X 
First on-study scans are expected during the Week 3 visit in the Recovery 
Period. 
Contrast enhanced CT of Chest, CT or MRI of upper abdomen (including 
adrenal glands, and full liver), and all other known and/or suspected sites 
of disease should be performed during approximately the Week 3 visit in 
Recovery Period. Use same imaging method as was used at screening. 
See Section 9.1.1 for further details. 
Brain Imagingb 
See notes 
MRI of the brain without and with contrast if clinically indicated. CT of 
the brain (without and with contrast) can be performed if MRI is 
contraindicated or based on Investigator discretion. See Section 9.1.1 for 
further details. 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
Complete at beginning of each clinic visit during Recovery Period including 
the End of Recovery visit. See Section 9.1.2 for further details. 
PGI-S 
X 
X 
FACT-L 
X 
X 
EQ-5D-5L 
X 
X 
HCRU 
X 
X 
See Section 9.9. 
Abbreviations: AE, adverse event; BP, blood pressure; CCRT, concurrent chemoradiotherapy; CT, computed tomography; ECG, electrocardiogram; 
ECOG, Eastern Cooperative Oncology Group; eCRF, electronic case report form; EQ-5D-5L, 5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional 
Assessment of Cancer Therapy - Lung; HR, heart rate; HCRU, healthcare resource utilization; IgG, immunoglobulin G; MRI, magnetic resonance imaging; 
NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; PE, physical examination; PGI-S, Patient Global Impression of Severity; SAE, 
serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of childbearing potential. 

Clinical Protocol 
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a Recovery Period will last approximately 3 to 6 weeks after completion of CCRT (ie, last dose of radiotherapy). If further delay (> 6 weeks) is needed, approval 
by medical monitor or designee is required to move on to the maintenance period, and this must be documented in the participant’s medical record. See 
Section 5.1.3 for details on the Recovery Period. If participant appears fully recovered at approximately the Week 3 visit, then all procedures required at End of 
Recovery Period may be performed at approximately the Week 3 visit. The approximately Week 3 visit will then be considered the End of Recovery Period 
visit. All safety assessments performed post week 3 during Recovery Period should be documented in the eCRFs or via external data transfer. Collection of 
outcome assessments should only be done once when more than one study visit occurs on the same day. If participant discontinues at the End of Recovery visit, 
the End of Recovery Visit may be considered as safety Follow-up 1 visit. If participant meets eligibility criteria of entering into maintenance period within 2 
weeks from the end of CCRT (ie, last dose of radiotherapy), maintenance treatment may be initiated earlier but no less than 18 days after the last dose of 
nivolumab (Arm A and Arm B). If participant meets eligibility criteria of entering into maintenance period but beyond Recovery Period window, approval by 
Medical Monitor or designee is needed and must be documented in medical record. 
b If the planned start of subsequent anticancer therapy is sooner than the time of next scheduled tumor assessment, every effort should be made to repeat tumor 
imaging prior to initiation of subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
40 
Approved v81.0 
930137110 8.0 
 
 
Table 2-5: 
On Study Treatment Procedural Outline – Maintenance Period – Arm A (Nivolumab Q3W + 
Ipilimumab Q6W) (CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
(6 weeks ± 3 days) 
Notes:b Cycle = 6 weeks 
D1c 
D22 
D1 
D22 
Safety Assessments 
Targeted PE, Weight, Vital 
Signs 
X 
X 
X 
X 
Weight, BP, HR, and temperature before treatment. Weight can be assessed up to 
24 hours prior to dosing. 
ECOG Performance status 
X 
X 
To be performed prior to treatment on D1. See Appendix 5. 
Adverse Events Assessment 
(including SAEs) 
Continuously 
All AEs (SAEs or non-serious AEs), including those associated with SARS-CoV- 
2 infection, must be collected continuously during the treatment period. 
Record at each visit. Collect continuously throughout the Maintenance Period. See 
Section 9.2.1 for the timing of AE/SAE collection. 
Concomitant Medication Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical Laboratory Testing 
X 
X 
X 
X 
Must be performed within 72 hrs prior to dosing. C1D1 labs do not need to be 
repeated if performed in the end of Recovery Period and within 72 hrs of C1D1 
dosing. See Table 9.4.4-1 for clinical safety laboratory assessments. 
Thyroid Stimulating 
Hormone 
X 
X 
TSH (with reflexive fT3 and fT4 if TSH is abnormal) must be performed within 
72 hrs prior to D1 of every cycle. For more details, see Table 9.4.4-1 for clinical 
safety laboratory assessments. 
Pregnancy Test WOCBP 
only 
X 
X 
X 
X 
Serum or urine pregnancy test must be performed within 72 hours before each 
dose or at least every 4 weeks (± 1 week) regardless of dosing schedule in cases of 
dose delays. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
41 
Approved v81.0 
930137110 8.0 
 
 
Table 2-5: 
On Study Treatment Procedural Outline – Maintenance Period – Arm A (Nivolumab Q3W + 
Ipilimumab Q6W) (CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
(6 weeks ± 3 days) 
Notes:b Cycle = 6 weeks 
D1c 
D22 
D1 
D22 
Efficacy Assessments 
Body Imagingd 
See note 
Contrast enhanced CT of Chest, CT or MRI of upper abdomen (including adrenal 
glands, and full liver), and other suspected sites of disease should be performed at 
week 24 (±7 days) from the date of randomization, then every 12 weeks (±7 days) 
during treatments. 
During treatment beyond progression (TBP), a follow up scan is required within 6 
weeks of initial Investigator-assessed PD to determine if there has been a 
reduction in tumor size, SD, or continued progression. If TBP continues beyond 
the 6 week scan (based on Investigator judgment), subsequent scans should be 
performed every 12 weeks (±7 days), or if additional worsening is suspected. 
Other anatomical sites should be imaged in the presence of signs or symptoms 
suggesting disease progression. Tumor assessment schedule should be maintained 
regardless of dose delays. 
Tumor assessments will continue until BICR confirmed disease progression, 
Investigator-assessed distant metastases, or treatment discontinuation due to 
additional PD during treatment beyond progression (TBP), whichever occurs later. 
Use same imaging method as was used at screening. 
All study treatment decisions will be based on the investigator’s assessment of 
tumor images. See Section 9.1.1.2 for additional details. 
Brain Imagingd 
See note 
To be performed as clinically indicated for suspicion of disease. See 
Section 9.1.1.2 for additional details. 
PK/Immunogenicity 
Assessments 
PK and immunogenicity sampling 
schedule specified in Table 9.5-2 
See Section 9.5 for complete details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
42 
Approved v81.0 
930137110 8.0 
 
 
Table 2-5: 
On Study Treatment Procedural Outline – Maintenance Period – Arm A (Nivolumab Q3W + 
Ipilimumab Q6W) (CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
(6 weeks ± 3 days) 
Notes:b Cycle = 6 weeks 
D1c 
D22 
D1 
D22 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
To be completed prior to treatment at the start of each maintenance cycle. 
If a dose is delayed, outcome assessments should also be delayed until dosing is 
resumed. See Section 9.1.2 for further details. 
PGI-S 
X 
X 
FACT-L 
X 
X 
EQ-5D-5L 
X 
X 
HCRU 
X 
X 
See Section 9.9. 
Study Treatment 
After participants complete Recovery Period, the first dose must be administered 
within 3 calendar days and no less than 18 days from the last dose of nivolumab. 
Maintenance Period will last approximately 12 months with each treatment cycle 
lasting 6 weeks. 
Nivolumab Q3W 
X 
X 
X 
X 
Nivolumab 360 mg administered on D1 and D22 of each cycle. See Section 7.1.1. 
Ipilimumab Q6W 
X 
X 
Ipilimumab 1 mg/kg administered on D1 of each cycle. Participant baseline 
weight at C1D1 or within 3 days prior to entering the Maintenance Period should 
be used for ipilimumab dosing calculation. 
A ≥ 10% change in weight from baseline requires recalculation for weight-based 
dosing. 
See Section 7.1.2 for further details. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; C, cycle; CRF, case report form; CT, computed tomography; D, 
day; ECOG, Eastern Cooperative Oncology Group; EQ-5D-5L, 5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer 
Therapy - Lung; 
; HCRU, healthcare resource utilization; HR, heart rate; IgG, immunoglobulin G; MRI, magnetic 
resonance imaging; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; PD, progressive disease; PE, physical examination; PGI-S, 
Patient Global Impression of Severity; PK, pharmacokinetic; Q3W, every 3 weeks; Q6W, every 6 weeks; SAE, serious adverse event; SARS-CoV-2, severe acute 
respiratory syndrome coronavirus 2; SD, stable disease; TBP, treatment beyond pregression; TSH, thyroid stimulating hormone; WOCBP, women of childbearing 
potential. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
43 
Approved v81.0 
930137110 8.0 
 
 
a If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
c Safety assessments on C1D1 do not need to be repeated if performed within 3 days of C1D1 at End of Recovery Period. 
d If the planned start of subsequent anticancer therapy is sooner than the time of next scheduled tumor assessment, every effort should be made to repeat tumor 
imaging prior to initiation of subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
44 
Approved v81.0 
930137110 8.0 
 
 
Table 2-6: 
On Study Treatment Procedural Outline – Maintenance Period – Arm B (Nivolumab Q4W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) 
and beyonda 
(4 weeks ± 3 days) 
Notes:b Cycle = 4 weeks 
D1c 
D1 
Safety Assessments 
Targeted PE, Weight, and 
Vital Signs 
X 
X 
Weight, BP, HR, and temperature prior to treatment. Weight can be assessed up to 24 
hours prior to dosing 
ECOG Performance 
Status 
X 
X 
To be performed prior to treatment on D1. See Appendix 5. 
Adverse Events 
Assessment 
(including SAEs) 
Continuously 
All AEs (SAEs or non-serious AEs), including those associated with SARS-CoV-2 
infection, must be collected continuously during the treatment period. 
Record at each visit. Collect continuously throughout the Maintenance Period. See 
Section 9.2.1 for the timing of AE/SAE collection. 
Concomitant Medication 
Use 
Continuously 
Record at each visit 
Laboratory Tests 
Clinical Laboratory 
Testing 
X 
X 
To be performed within 72 hrs prior to dosing. See Table 9.4.4-1 for clinical safety 
laboratory assessments. C1D1 labs do not need to be repeated if end of Recovery labs 
were performed within 72 hrs of dosing. 
Thyroid Stimulating 
Hormone 
X 
X 
TSH (with reflexive fT3 and fT4 if TSH is abnormal) must be performed within 72 hrs 
prior to D1 of every cycle. For more details, see Table 9.4.4-1 for clinical safety 
laboratory assessments. 
Pregnancy Test WOCBP 
X 
X 
Serum or urine pregnancy test must be performed within 72 hours before each dose or 
at least every 4 weeks (± 1 week) regardless of dosing schedule in cases of dose 
delays. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
45 
Approved v81.0 
930137110 8.0 
 
 
Table 2-6: 
On Study Treatment Procedural Outline – Maintenance Period – Arm B (Nivolumab Q4W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) 
and beyonda 
(4 weeks ± 3 days) 
Notes:b Cycle = 4 weeks 
D1c 
D1 
Efficacy Assessments 
Body Imagingd 
See note 
Contrast enhanced CT of Chest , CT or MRI of upper abdomen (including adrenal 
glands, and full liver), and other suspected sites of disease should be performed at 
week 24 (±7 days) from the date of randomization, then every 12 weeks (±7 days) 
during treatment. 
During treatment beyond progression (TBP), a follow up scan is required within 
6 weeks of initial Investigator-assessed PD to determine if there has been a reduction 
in tumor size, SD, or continued progression. If TBP continues beyond the 6 week scan 
(based on Investigator judgment), subsequent scans should be performed every 
12 weeks (±7 days), or if additional worsening is suspected. 
Other anatomical sites should be imaged in the presence of signs or symptoms 
suggesting disease progression. Tumor assessment schedule should be maintained 
regardless of dose delays. 
Tumor assessments will continue until BICR confirmed disease progression, 
Investigator-assessed distant metastases, or treatment discontinuation due to additional 
PD during TBP, whichever occurs later. 
Use same imaging method as was used at screening. All study treatment decisions will 
be based on the investigator’s assessment of tumor images. 
See Section 9.1.1.2 for additional details. 
Brain Imagingd 
See note 
To be performed as clinically indicated for suspicion of disease. See Section 9.1.1.2 
for additional details. 
PK/Immunogenicity 
Assessments 
PK and Immunogenicity sampling 
schedule specified in Table 9.5-4. 
See Section 9.5 for complete details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
46 
Approved v81.0 
930137110 8.0 
 
 
Table 2-6: 
On Study Treatment Procedural Outline – Maintenance Period – Arm B (Nivolumab Q4W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) 
and beyonda 
(4 weeks ± 3 days) 
Notes:b Cycle = 4 weeks 
D1c 
D1 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
To be completed prior to treatment at the start of each maintenance cycle. 
If a dose delay occurs, outcome assessments should also be delayed until dosing is 
resumed. See Section 9.1.2 for further details. 
PGI-S 
X 
X 
FACT-L 
X 
X 
EQ-5D-5L 
X 
X 
HCRU 
X 
X 
See Section 9.9. 
Study Treatment 
After participants complete Recovery Period, the first dose must be administered 
within 3 calendar days and no less than 18 days from the last dose of nivolumab. 
Maintenance Period will last approximately 12 months with each treatment cycle 
lasting 4 weeks. 
Nivolumab Q4W 
X 
X 
Nivolumab 480 mg administered on D1 of each cycle. Participants may be dosed no 
less than 25 days from the previous dose of nivolumab during Q4W cycles. See 
Section 7.1.1. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; C, cycle; CRF, case report form; CT, computed tomography; D, 
day; ECOG, Eastern Cooperative Oncology Group; EQ-5D-5L, 5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer 
Therapy - Lung; 
; HCRU, healthcare resource utilization; HR, heart rate; IgG, immunoglobulin G; MRI, magnetic 
resonance imaging; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; PD, progressive disease; PE, physical examination; PGI-S, 
Patient Global Impression of Severity; PK, pharmacokinetic; Q4W, every 4 weeks; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome 
coronavirus 2; SD, stable disease; TBP, treatment beyond progression; TSH, thyroid stimulating hormone; WOCBP, women of childbearing potential. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
47 
Approved v81.0 
930137110 8.0 
 
 
a If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
c Safety assessments on C1D1 do not need to be repeated if performed within 3 days of C1D1 at End of Recovery Period. 
d If the planned start of subsequent anticancer therapy is sooner than the time of next scheduled tumor assessment, every effort should be made to repeat tumor 
imaging prior to initiation of subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
48 
Approved v81.0 
930137110 8.0 
 
 
Table 2-7: 
On Study Treatment Procedural Outline – Maintenance Period – Arm C (Durvalumab Q2W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
Notes:b (Cycle = 2 weeks ± 3 days) 
D1c 
D1 
Safety Assessments 
Targeted PE, Weight, and Vital 
Signs 
X 
X 
Weight, BP, HR, and temperature prior to treatment. Weight can be assessed up 
to 24 hours prior to dosing. 
ECOG Performance Status 
X 
X 
To be performed prior to treatment. See Appendix 5. 
Adverse Events Assessment 
(including SAEs) 
Continuously 
All AEs (SAEs or non-serious AEs), including those associated with SARS- 
CoV-2 infection, must be collected continuously during the treatment period. 
Record at each visit. Collect continuously throughout the Maintenance Period. 
See Section 9.2.1 for the timing of AE/SAE collection. 
Concomitant Medication Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical Laboratory Testing 
X 
X 
To be performed within 72 hours prior to dosing. C1D1 labs do not need to be 
repeated if end of Recovery labs were performed within 72 hrs of C1D1 dosing. 
See Table 9.4.4-1 for clinical safety laboratory assessments. 
Thyroid Stimulating Hormone 
X 
X 
TSH (with reflexive fT3 and fT4 if TSH is abnormal) must be performed within 
72 hrs prior to D1 of every cycle. For more details, see Table 9.4.4-1 for clinical 
safety laboratory assessments. 
Pregnancy Test WOCBP 
X 
X 
Serum or urine pregnancy test must be performed within 72 hours before each 
dose or at least every 4 weeks (± 1 week) regardless of dosing schedule in cases 
of dose delays. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
49 
Approved v81.0 
930137110 8.0 
 
 
Table 2-7: 
On Study Treatment Procedural Outline – Maintenance Period – Arm C (Durvalumab Q2W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
Notes:b (Cycle = 2 weeks ± 3 days) 
D1c 
D1 
Efficacy Assessments 
Body Imagingd 
See note 
Contrast enhanced CT of Chest, CT or MRI of upper abdomen (including 
adrenal glands, and full liver), and other suspected sites of disease should be 
performed at week 24 (± 7 days) from the date of randomization, then every 
12 weeks (± 7 days) during treatment. 
During treatment beyond progression (TBP), a follow up scan is required within 
6 weeks of initial Investigator-assessed PD to determine if there has been a 
reduction in tumor size, SD, or continued progression. If TBP continues beyond 
the 6 week scan (based on Investigator judgment), subsequent scans should be 
performed every 12 weeks (± 7 days), or if additional worsening is suspected. 
Other anatomical sites should be imaged in the presence of signs or symptoms 
suggesting disease progression. Tumor assessment schedule should be 
maintained regardless of dose delays. 
Tumor assessments will continue until BICR confirmed disease progression, 
Investigator-assessed distant metastases, or treatment discontinuation due to 
additional PD during TBP, whichever occurs later. Use same imaging method 
as was used at screening. 
All study treatment decisions will be based on the investigator’s assessment of 
tumor images. See Section 9.1.1.2 for additional details. 
Brain Imagingd 
See note 
To be performed as clinically indicated for suspicion of disease. See 
Section 9.1.1.2 for additional details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
50 
Approved v81.0 
930137110 8.0 
 
 
Table 2-7: 
On Study Treatment Procedural Outline – Maintenance Period – Arm C (Durvalumab Q2W) 
(CA20973L) 
 
Procedure 
Cycle 1 
(Maintenance)a 
Cycle 2 
(Maintenance) and 
beyonda 
Notes:b (Cycle = 2 weeks ± 3 days) 
D1c 
D1 
Outcomes Assessments 
NSCLC-SAQ 
See notes 
To be completed prior to treatment at the start of maintenance cycle at: 
C1, C3, C4, C5, C7, C9, C10, C11, C13, C15, C16, C17, C19, C21, C22, C23, 
and C25. If a dose is delayed, outcome assessments should also be delayed until 
dosing is resumed. See Section 9.1.2 for further details. 
PGI-S 
FACT-L 
EQ-5D-5L 
HCRU 
X 
X 
See Section 9.9. 
Study Treatment 
After participants complete Recovery Period, the first dose must be 
administered within 3 calendar days. Maintenance Period will last 
approximately 12 months with each treatment cycle lasting 2 weeks. 
Durvalumab Q2W 
X 
X 
Durvalumab 10 mg/kg administered on D1 of each cycle. The participant’s 
baseline weight at C1D1 or within 3 days prior to entering the Maintenance 
Period must be used for durvalumab dosing calculation. From C2D1 and 
onwards, dosing should be calculated based on the weight assessed prior to each 
dosing or per local approved label. See Section 7.1.3. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; C = cycle; CRF, case report form; CT, computed tomography; 
D, day; ECOG, Eastern Cooperative Oncology Group; EQ-5D-5L, 5-level version of the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer 
Therapy - Lung; 
; HCRU, healthcare resource utilization; HR, heart rate; IgG, immunoglobulin G; MRI, magnetic 
resonance imaging; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; PD, progressive disease; PE, physical examination; PGI-S, 
Patient Global Impression of Severity; Q2W, every 2 weeks; SAE, serious adverse event; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2; SD, 
stable disease; TBP, treatment beyond progression; TSH, thyroid stimulating hormone; WOCBP, women of childbearing potential. 
a If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 
b Some of the assessments referred to in this section may not be captured as data in the CRF. They are intended to be used as safety monitoring by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
51 
Approved v81.0 
930137110 8.0 
 
 
c Safety assessments on C1D1 do not need to be repeated if performed within 3 days of C1D1 at End of Recovery Period. 
d If the planned start of subsequent anticancer therapy is sooner than the time of next scheduled tumor assessment, every effort should be made to repeat tumor 
imaging prior to initiation of subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-8: 
Follow-Up Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
52 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Safety Follow-Up 
Visit 1a 
30 Days from 
Last Dose 
(± 7 Days) 
Safety Follow- 
Up Visit 2a 
100 days from 
Last Dose 
(± 7 Days) 
Tumor 
Assessments 
Every 3-6 
months 
(± 7 days) 
Survival Follow-Upa 
Every 3 months 
from Follow-Up 
Visit 2 
(± 14 days) 
Notesb 
Safety Assessments 
Targeted Physical 
Examination, Weight, and 
Vital Sign 
X 
X 
Weight, BP, HR, and temperature. 
ECOG Performance Status 
X 
X 
See Appendix 5. 
Adverse Events Assessment 
(including SAEs) 
X 
X 
See notes 
See notes 
All SAEs and non-serious AEs should be 
collected continuously during the treatment 
period and for a minimum of 100 days 
following discontinuation of dosing. 
Participants will be followed for all SAEs, 
non-serious AEs of special interest (as 
defined in Section 9.2), and all AEs (SAEs 
and non-serious AEs) associated with 
confirmed or suspected SARS-CoV-2 
infection until resolution, the condition 
stabilizes, the event is otherwise explained, 
the event is deemed irreversible, the 
participant is lost to follow-up (as defined in 
Section 8.3), or for suspected cases, until 
SARS-CoV-2 infection is ruled-out. 
Beyond 100 days from the last dose of 
study therapy, participants will be followed 
for drug-related AEs/SAEs until resolution, 
returns to baseline, is deemed irreversible, 
or until the participant is lost to follow-up 
or withdraws study consent. 
See Section 9.2 for additional information. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-8: 
Follow-Up Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
53 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Safety Follow-Up 
Visit 1a 
30 Days from 
Last Dose 
(± 7 Days) 
Safety Follow- 
Up Visit 2a 
100 days from 
Last Dose 
(± 7 Days) 
Tumor 
Assessments 
Every 3-6 
months 
(± 7 days) 
Survival Follow-Upa 
Every 3 months 
from Follow-Up 
Visit 2 
(± 14 days) 
Notesb 
Concomitant Medication 
Use 
X 
X 
See note 
In Survival Follow-up, subsequent cancer 
treatment only. 
Laboratory Tests 
Clinical Laboratory Testing 
X 
See Notes 
To be performed at Safety Follow-up Visit 
2, if toxicities remain. 
See Table 9.4.4-1 for clinical safety 
laboratory assessments. 
Pregnancy Test WOCBP 
X 
X 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-8: 
Follow-Up Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
54 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Safety Follow-Up 
Visit 1a 
30 Days from 
Last Dose 
(± 7 Days) 
Safety Follow- 
Up Visit 2a 
100 days from 
Last Dose 
(± 7 Days) 
Tumor 
Assessments 
Every 3-6 
months 
(± 7 days) 
Survival Follow-Upa 
Every 3 months 
from Follow-Up 
Visit 2 
(± 14 days) 
Notesb 
Efficacy Assessments 
Body Imagingc,d 
See notes 
In Follow-up Period, participants without 
BICR-confirmed progression and/or 
Investigator-assessed distant metastases 
only will receive contrast enhanced CT of 
Chest, CT or MRI of upper abdomen 
(including adrenal glands, and full liver), 
and other suspected sites of disease 
• 
every 12 weeks (±7 days) for up to and 
including 36 months from date of 
randomization, 
• 
then every 24 weeks (±7 day) after 
month 36 from date of randomization. 
Other anatomical sites should be imaged in 
the presence of signs or symptoms 
suggesting disease progression. 
Tumor assessments will continue until 
BICR confirmed disease progression or 
Investigator-assessed distant metastases, 
whichever occurs later. Use the same 
imaging method as was used at Screening. 
See Section 9.1.1.2 for additional details. 
Brain Imagingc,d 
See notes 
In Follow-up Period, brain imaging is only 
required for participants without BICR- 
confirmed progression and/or Investigator 
assessed distant metastases. To be 
performed as clinically indicated for 
suspicion of disease. See Section 9.1.1.2 for 
additional details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-8: 
Follow-Up Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
55 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Safety Follow-Up 
Visit 1a 
30 Days from 
Last Dose 
(± 7 Days) 
Safety Follow- 
Up Visit 2a 
100 days from 
Last Dose 
(± 7 Days) 
Tumor 
Assessments 
Every 3-6 
months 
(± 7 days) 
Survival Follow-Upa 
Every 3 months 
from Follow-Up 
Visit 2 
(± 14 days) 
Notesb 
Survival Status 
X 
X 
X 
Survival Follow-up visits to occur every 3 
months (±14 days) from Safety Follow-up 
Visit 2. Survival visits may be conducted in 
person or by telephone (phone contact is an 
option after BICR confirmed PD and 
Investigator assessed distant metastases, or 
after month 36 from date of randomization 
if not coinciding with a tumor assessment 
visit). BMS may request that survival data 
are collected on all treated participants 
outside of the 3 month window. 
Subsequent PD (PFS-2) 
X 
X 
X 
X 
For participants who start subsequent 
anticancer therapy, subsequent PD date and 
diagnosis method during subsequent 
treatment will be recorded on the CRF 
during the Follow-up Period. 
Subsequent PD assessment takes participant 
status at 1st PD (per Investigator 
assessment) as re-baseline, is defined per 
local standard practice, and may entail 
radiological PD, clinical PD, or other. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-8: 
Follow-Up Period – All Arms (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
56 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Safety Follow-Up 
Visit 1a 
30 Days from 
Last Dose 
(± 7 Days) 
Safety Follow- 
Up Visit 2a 
100 days from 
Last Dose 
(± 7 Days) 
Tumor 
Assessments 
Every 3-6 
months 
(± 7 days) 
Survival Follow-Upa 
Every 3 months 
from Follow-Up 
Visit 2 
(± 14 days) 
Notesb 
Subsequent Anticancer 
Therapyd 
X 
X 
X 
X 
Following Investigator-assessed PD, 
participants will be discontinued from 
treatment and assessed at survival follow-up 
visits (every 3 months) for subsequent 
progression (ie, PFS-2). Information on the 
subsequent PD, subsequent anticancer 
therapy and outcome must be collected. 
Additional subsequent cancer therapy 
information such as regimen, setting of the 
regimen, line of therapy, start date and end 
date of each regimen, best response to the 
regimen, and date of progression after next 
line of therapy will be collected. 
Outcomes Assessments 
NSCLC-SAQ 
X 
X 
X 
Assessments will be collected on Safety 
Follow up Visit 1 and 2 for all participants. 
For participants who complete/discontinue 
from the Maintenance Period, continue at 
every tumor assessment visit until BICR 
confirmed disease progression. 
In addition, EQ-5D-5L to be collected at 
every survival visit which is not associated 
with tumor assessment visits, including 
phone contact for the survival. 
Outcome assessments will not be performed 
during the re-treatment follow-up period. 
PGI-S 
X 
X 
X 
FACT-L 
X 
X 
X 
EQ-5D-5L 
X 
X 
X 
X 
HCRU 
X 
X 
X 
See Section 9.9 for further details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
57 
Approved v81.0 
930137110 8.0 
 
 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BMS, Bristol-Myers Squibb; BP, blood pressure; CRF, case report form; 
CT, computed tomography; ECOG, Eastern Cooperative Oncology Group; eCRF, electronic case report form; EQ-5D-5L, 5-level version of the EuroQol Group’s 
EQ-5D; FACT-L, Functional Assessment of Cancer Therapy - Lung; 
; HCRU, healthcare resource utilization; HR, heart 
rate; IgG, immunoglobulin G; MRI, magnetic resonance imaging; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; PD, 
progressive disease; PFS-2, progression-free survival on next line therapy; PGI-S, Patient Global Impression of Severity; SAE, serious adverse event; SARS-CoV- 
2, severe acute respiratory syndrome coronavirus 2; WOCBP, women of childbearing potential. 
a Participants must be followed for at least 100 days after the last dose of study treatment. Safety Follow-up Visit 1 should occur 30 days from the last dose (± 7 
days). If participant delays treatment and later discontinues treatment > 42 days from the last treatment, the Safety Follow-up Visit 1 may be performed at time 
of discontinuation. Safety Follow-up Visit 2 occurs approximately 100 days (± 7 days) from the last dose of study treatment. Both follow-up visits should be 
conducted in person. 
b Some assessments referred to in this section may not be captured as data in the eCRF. These assessments are intended to be used as safety monitor by the treating 
physician. Additional testing or assessments may be performed as clinically necessary or where required by institutional or local regulations. 
c See Section 5.1.6 for imaging requirements after retreatment period. 
d If the planned start of subsequent anticancer therapy is sooner than the time of next scheduled tumor assessment, every effort should be made to repeat tumor 
imaging prior to initiation of subsequent anticancer therapy. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-9: 
Optional Retreatment Procedural Outline - Arm A (Nivolumab Q3W + Ipilimumab Q6W) (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
58 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Screening for 
Retreatmenta 
Cycle 1 
Retreatmentb 
Cycle 2 
Retreatment and 
beyondb 
(6 weeks ± 3 days) 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D22 
D1 
D22 
Informed Consent 
X 
Participants must be re-consented for retreatment. 
Eligibility Assessment 
X 
X 
See Section 5.1.6. 
Safety Assessments 
Targeted PE, Weight, Vital Signs 
X 
X 
X 
X 
X 
Weight, BP, HR, and temperature before treatment. Weight can 
be assessed up to 24 hours prior to dosing. 
ECOG Performance status 
X 
X 
X 
To be performed prior to treatment on D1. See Appendix 5. 
Adverse Events Assessment 
(including SAEs) 
Continuously 
Record at each visit. Collect continuously throughout the 
Retreatment Period. See Section 9.2.1 for the timing of 
AE/SAE collection. 
Concomitant Medication Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical Laboratory Testing 
X 
X 
X 
X 
X 
Must be performed within 72 hrs prior to dosing. Retreatment 
C1D1 labs do not need to be repeated if performed in the initial 
Follow-up Period and within 72 hrs prior to retreatment C1D1 
dosing. See Table 9.4.4-1 for clinical safety laboratory 
assessments. 
Pregnancy Test WOCBP only 
X 
X 
X 
X 
X 
Serum or urine pregnancy test must be performed within 72 
hours before each dose or at least every 4 weeks (± 1 week) 
regardless of dosing schedule in cases of dose delays. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-9: 
Optional Retreatment Procedural Outline - Arm A (Nivolumab Q3W + Ipilimumab Q6W) (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
59 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Screening for 
Retreatmenta 
Cycle 1 
Retreatmentb 
Cycle 2 
Retreatment and 
beyondb 
(6 weeks ± 3 days) 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D22 
D1 
D22 
Efficacy Assessments 
Body Imaging 
X 
See note 
Contrast enhanced CT of Chest, CT or MRI of upper abdomen 
(including adrenal glands, and full liver), and other suspected 
sites of disease should be performed at every 12 weeks 
(±7 days) from BICR confirmed initial disease progression 
(starting from date of scan). 
Tumor assessment schedule should be maintained regardless of 
dose delays. 
Scans do not need to be submitted to BICR. Subsequent PD 
during the Retreatment Period will be per investigator’s 
assessment. Treatment beyond second progression is not 
allowed. 
Participants without Investigator-assessed distant metastases 
must continue tumor scans during the Retreatment Period until 
metastasis is assessed by the Investigator. 
Use same imaging method used at screening. All study 
treatment decisions will be based on the investigator’s 
assessment of tumor images. 
See Section 5.1.6 and Section 9.1.1.2 for additional details. 
Brain Imaging 
X 
See note 
To be performed as clinically indicated for suspicion of 
disease. 
Scans do not need to be submitted to BICR. Subsequent PD 
during the Retreatment Period will be per investigator’s 
assessment. Treatment beyond second progression is not 
allowed. 
See Section 5.1.6 and Section 9.1.1.2 for additional details. 

Clinical Protocol 
BMS-936558 
CA20973L 
nivolumab 
Table 2-9: 
Optional Retreatment Procedural Outline - Arm A (Nivolumab Q3W + Ipilimumab Q6W) (CA20973L) 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
60 
Approved v81.0 
930137110 8.0 
 
 
 
 
Procedure 
Screening for 
Retreatmenta 
Cycle 1 
Retreatmentb 
Cycle 2 
Retreatment and 
beyondb 
(6 weeks ± 3 days) 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D22 
D1 
D22 
Study Treatment 
Participants who enter the Follow-up Period with ongoing 
disease control (CR, PR, or SD) and without a history of 
treatment beyond progression, may receive retreatment in Arm 
A upon BICR confirmed disease progression. Retreatment 
Period will last up to 12 months with each treatment cycle 
lasting 6 weeks. 
Nivolumab Q3W 
X 
X 
X 
X 
Nivolumab 360 mg administered on D1 and D22 of each cycle. 
See Section 7.1.1. 
Ipilimumab Q6W 
X 
X 
Ipilimumab 1 mg/kg administered on D1 of each cycle. 
Participant baseline weight at C1D1 or within 3 days prior to 
entering the Retreatment Period should be used for ipilimumab 
dosing calculation. 
A ≥ 10% change in weight from baseline requires recalculation 
for weight-based dosing. 
See Section 7.1.2 for further details. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; C, cycle; CR, complete response; CT, computed tomography; 
D, day; ECOG, Eastern Cooperative Oncology Group; HR, heart rate; MRI, magnetic resonance imaging; PD, progressive disease; PE, physical examination; PR, 
partial response; Q3W, every 3 weeks; Q6W, every 6 weeks; SAE, serious adverse event; SD, stable disease; WOCBP, women of childbearing potential. 
a Safety assessments on C1D1 do not need to be repeated if performed within 3 days of C1D1 at Retreatment Screening Period. 
b If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 

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Procedure 
Screening for 
Retreatmenta 
Cycle 1 
(Retreatment)b 
Cycle 2 
(Retreatment) and 
beyond 
(4 weeks ± 3 days)b 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D1 
Informed Consent 
X 
Participants must be re-consented for retreatment. 
Eligibility Assessment 
X 
X 
See Section 5.1.6. 
Safety Assessments 
Targeted PE, Weight, and Vital 
Signs 
X 
X 
X 
Weight, BP, HR, and temperature prior to treatment. 
Weight can be assessed up to 24 hours prior to dosing. 
ECOG Performance Status 
X 
X 
X 
To be performed prior to treatment. See Appendix 5. 
Adverse Events Assessment 
(including SAEs) 
Continuously 
Record at each visit. Collect continuously throughout the 
Retreatment Period. See Section 9.2.1 for the timing of 
AE/SAE collection. 
Concomitant Medication Use 
Continuously 
Record at each visit. 
Laboratory Tests 
Clinical Laboratory Testing 
X 
X 
X 
Must be performed within 72 hrs prior to dosing. 
Retreatment C1D1 labs do not need to be repeated if 
performed in the initial Follow-up Period and within 
72 hours prior to retreatment C1D1 dosing. See 
Table 9.4.4-1 for clinical safety laboratory assessments. 
Pregnancy Test WOCBP 
X 
X 
X 
Serum or urine pregnancy test must be performed within 
72 hours before each dose or at least every 4 weeks (± 1 
week) regardless of dosing schedule in cases of dose 
delays. 

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Procedure 
Screening for 
Retreatmenta 
Cycle 1 
(Retreatment)b 
Cycle 2 
(Retreatment) and 
beyond 
(4 weeks ± 3 days)b 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D1 
Efficacy Assessments 
Body Imaging 
X 
See note 
Contrast enhanced CT of Chest, CT or MRI of upper 
abdomen (including adrenal glands, and full liver), and 
other suspected sites of disease should be performed at 
every 12 weeks (±7 days) from BICR confirmed initial 
disease progression (starting from date of scan). 
Tumor assessment schedule should be maintained 
regardless of dose delays. 
Scans do not need to be submitted to BICR. Subsequent 
PD during the Retreatment Period will be per 
investigator’s assessment. Treatment beyond second 
progression is not allowed. 
Participants without Investigator-assessed distant 
metastases must continue tumor scans during the 
Retreatment Period until metastasis is assessed by the 
Investigator. 
Use same imaging method used at screening. All study 
treatment decisions will be based on the investigator’s 
assessment of tumor images. 
See Section 9.1.1.2 for additional details. 
Brain Imaging 
X 
See note 
To be performed as clinically indicated for suspicion of 
disease. Scans do not need to be submitted to BICR. 
Subsequent PD during the Retreatment Period will be per 
investigator’s assessment. Treatment beyond second 
progression is not allowed. 
See Section 9.1.1.2 for additional details. 

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Procedure 
Screening for 
Retreatmenta 
Cycle 1 
(Retreatment)b 
Cycle 2 
(Retreatment) and 
beyond 
(4 weeks ± 3 days)b 
Notes: Screening visit may occur on same day as C1D1 
retreatment visit 
-28 Days 
D1 
D1 
Study Treatment 
Participants who enter the Follow-up Period with ongoing 
disease control (CR, PR, or SD) and without a history of 
treatment beyond progression, may receive retreatment in 
Arm B upon BICR confirmed disease progression. 
Retreatment Period will last up to 12 months with each 
treatment cycle lasting 4 weeks. 
Nivolumab Q4W 
X 
X 
Nivolumab 480 mg administered on D1 of each cycle. See 
Section 7.1.1. 
Abbreviations: AE, adverse event; BICR, blinded independent central review; BP, blood pressure; C, cycle; CR, complete response; CT, computed tomography; 
D, day; ECOG, Eastern Cooperative Oncology Group; HR, heart rate; MRI, magnetic resonance imaging; PD, progressive disease; PE, physical examination; PR, 
partial response; Q4W, every 4 weeks; SAE, serious adverse event; SD, stable disease; WOCBP, women of childbearing potential. 
a Safety assessments on C1D1 do not need to be repeated if performed within 3 days of C1D1 at Retreatment Screening Period. 
b If a dose is delayed, the procedures scheduled for that same time point must also be delayed to coincide with when that time point’s dosing actually occurs, with 
the exception of tumor assessments which must occur as scheduled. 

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3 
INTRODUCTION 
CA20973L is a phase 3, randomized, open label study to compare nivolumab plus concurrent 
chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab or nivolumab alone versus 
CCRT followed by durvalumab in previously untreated locally advanced non-small cell lung 
cancer (LA NSCLC). 
Immunotherapeutic approaches have recently demonstrated clinical efficacy in several cancer 
types, including NSCLC.1 Tumors may modulate and evade the host immune response through a 
number of mechanisms, including down regulation of tumor-specific antigen expression and 
presentation, secretion of anti-inflammatory cytokines, and upregulation of inhibitory ligands. T 
cell checkpoint regulators such as CTLA-4 and programmed death-1 (PD-1, CD279) are cell 
surface molecules that, when engaged by their cognate ligands, induce signaling cascades down- 
regulating T cell activation and proliferation. One proposed model by which therapeutic T cell 
checkpoint inhibitors derive antitumor activity is through breaking of immune tolerance to tumor 
cell antigens. 
Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on 
activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 
(B7-H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and 
augmenting the host antitumor response (see Section 3.2.2.2 and Section 3.2.3 for clinical 
background on nivolumab and nivolumab plus ipilimumab combination). 
Durvalumab is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that 
inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). In the phase 3 
PACIFIC trial, durvalumab was compared with placebo as maintenance therapy in patients with 
stage III NSCLC that did not progress after CCRT. Durvalumab significantly prolonged PFS 
(median 17.2 months vs 5.6 months, HR 0.51; 95% CI, 0.41 to 0.63), and OS (HR 0.68; 99.73% 
CI, 0.47 to 0.997, P=0.0025).2 Updated analyses at 48 months further observed an estimated PFS 
and OS rate of 35.3% and 49.6%, respectively.3 
Ipilimumab is a fully human monoclonal IgG1κ that binds to the CTLA-4 antigen expressed on a 
subset of T cells from human and nonhuman primates. The proposed mechanism of action for 
ipilimumab is interference of the interaction of CTLA-4 with B7 molecules on antigen-presenting 
cell (APCs), with subsequent blockade of the inhibitory modulation of T-cell activation promoted 
by the CTLA-4/B7 interaction. 
The CA20973L study will allow for direct comparison of novel therapeutic strategy: CCRT with 
concurrent programmed cell death protein-1 /programmed death-ligand 1 (PD-1/PD-L1) blockade 
followed by PD-1/PD-L1 blockade with or without CTLA-4 blockade, compared with PD-1/PD- 
L1 blockade alone after CCRT, as measured by PFS, OS, and other clinical endpoints in previously 
untreated LA NSCLC. 

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3.1 
Study Rationale 
Adding anti PD-1 concurrently to CCRT is hypothesized to improve anti-tumor activity (see 
Section 5.4.2). In the PACIFIC trial, durvalumab was given after the completion of CCRT. In 
subgroup analyses, more pronounced improvement in median PFS and OS was seen in participants 
randomized within 14 days of the last radiation dose compared to participants randomized later, 
suggesting that initiating PD-1/PD-L1 blockade closer to CCRT may be beneficial.4 In a mouse 
model, different combination schedules were assessed. It was observed that initiating PD-1/PD-L1 
blockade during radiotherapy led to longer survival times, whereas starting PD-1/PD-L1 blockade 
7 days after the completion of radiotherapy yielded similar survival results when compared with 
radiotherapy alone, which might be due to an acute increase in PD-L1 expression on tumor cells 
during radiotherapy.5 Ineffective PD-1/PD-L1 blockade when given in a delayed manner might be 
explained by the deletion or anergy of tumor-reactive CD8+ cells. In a phase 2 trial (NICOLAS), 
nivolumab is given concurrently with chemoradiation in locally advanced NSCLC. Preliminary 
data (see Section 3.2.4) suggested this approach is feasible and safe. 6 Another phase 2 trial 
combining atezolizumab concurrently with chemoradiation in locally advanced NSCLC showed 
similar findings.7 
Furthermore, in the Maintenance Period following CCRT, combining immunotherapeutic agents 
with different mechanisms of action offers the possibility of a synergistic response. PD-1 and 
CTLA-4 are both co-inhibitory molecules, but evidence suggests that they use distinct mechanisms 
to limit T cell activation (see Section 3.2.3 and Section 3.2.4 for clinical experience). Preliminary 
indirect data from peripheral T cell assessments suggest that a given T-cell checkpoint inhibitor 
may modulate host immune cell phenotype rendering them more susceptible to alternate 
checkpoint inhibitors and thereby enhancing anti-tumor activity. Available evidence also indicates 
that incorporating ipilimumab into radiotherapy-based strategy holds promise as, besides abscopal 
effect, durable response has been observed with ipilimumab in the context of palliative 
radiotherapy in treating metastatic, refractory NSCLC (see Section 5.4.3). 
The current study aims to demonstrate that incorporation of nivolumab to definitive CCRT 
followed by nivolumab with/without ipilimumab will be efficacious in participants with newly 
diagnosed untreated LA NSCLC, compared with CCRT followed by durvalumab. Additional 
objectives of the study include characterization of safety and tolerability, as well as 
pharmacokinetics, 
and changes in patient-reported outcomes for 
quality of life assessments. The safety and efficacy of ipilimumab added to nivolumab 
maintenance therapy will be characterized descriptively. 
3.1.1 
Research Hypothesis 
CCRT with concurrent nivolumab followed by nivolumab plus ipilimumab will improve PFS and 
OS in previously untreated LA NSCLC compared with CCRT followed by durvalumab. 

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3.2 
Background 
3.2.1 
Epidemiology/Indication 
Lung cancer has been the most common cancer in the world for several decades. There were 
estimated to be 1.8 million new cases in 2012 (12.9% of the total). Lung cancer is the most 
common cause of death from cancer worldwide, estimated to be responsible for nearly one in five 
(1.59 million deaths, 19.4% of the total).8 
Non-small cell lung cancer (NSCLC) represents approximately 80% to 85% of all lung cancers 
and 30% of patients present with Stage III disease. Standard treatment for patients with a good 
performance status and unresectable Stage III NSCLC was definitive chemoradiation. A meta- 
analysis of concurrent chemoradiotherapy versus sequential chemoradiotherapy showed better 
outcomes with concurrent therapy.9 With improvements such as in staging by using PET and in 
radiation technologies, 5-year overall survival (OS) was reported up to 30-35%.10 
Attempts to improve OS include radiotherapy dose escalation/acceleration; new chemotherapy 
combinations, addition of biological agents, targeted agents, and cancer vaccines to standard 
regimens. Technical radiotherapy modifications have also been explored. However, none of these 
efforts has led to an improvement in OS thus far, except for acceleration of radiotherapy in the 
non-concurrent setting.11 Recently, durvalumab, an anti-PD-L1 agent, showed an improvement in 
median PFS, as well as OS in maintenance after CCRT.2 It is becoming the new standard of care. 
However, the majority of patients still experienced disease progression or death during the first 
two years of therapy (18-month PFS rate of 44.2%), and only 57% of patients were alive at 
3 years.4,12 As this stage of disease is potentially curable, new treatment strategies are needed. 
3.2.2 
Mechanism of Action 
Cancer immunotherapy rests on the premise that tumors can be recognized as foreign rather than 
as self and can be effectively attacked by an activated immune system. An effective immune 
response in this setting is thought to rely on immune surveillance of tumor antigens expressed on 
cancer cells that ultimately results in an adaptive immune response and cancer cell death. 
Meanwhile, tumor progression may depend upon acquisition of traits that allow cancer cells to 
evade immunosurveillance and escape effective innate and adaptive immune responses.13,14,15 
Current immunotherapy efforts attempt to break the apparent tolerance of the immune system to 
tumor cells and antigens by either introducing cancer antigens by therapeutic vaccination or by 
modulating regulatory checkpoints of the immune system. T-cell stimulation is a complex process 
involving the integration of numerous positive as well as negative co-stimulatory signals in 
addition to antigen recognition by the TCR. 16 Collectively, these signals govern the balance 
between T-cell activation and tolerance. 
3.2.2.1 
Ipilimumab Mechanism of Action 
CTLA-4, an activation-induced T-cell surface molecule, is a member of the CD28:B7 
immunoglobulin superfamily that competes with CD28 for B7. CTLA-4 mediated signals are 
inhibitory and turn off T cell-dependent immune responses. 17 Ipilimumab is a fully human 

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monoclonal IgG1κ that binds to the CTLA-4 antigen expressed on a subset of T cells from human 
and nonhuman primates. The proposed mechanism of action for ipilimumab is interference of the 
interaction of CTLA-4 with B7 molecules on APCs, with subsequent blockade of the inhibitory 
modulation of T-cell activation promoted by the CTLA 4/B7 interaction. 
3.2.2.2 
Nivolumab Mechanism of Action 
PD-1 is a member of the CD28 family of T-cell co-stimulatory receptors that also includes CD28, 
CTLA-4, ICOS, and BTLA. 18 PD-1 signaling has been shown to inhibit CD-28-mediated 
upregulation of IL-2, IL-10, IL-13, IFN-γ and Bcl-xL. PD-1 expression also has been noted to 
inhibit T cell activation, and expansion of previously activated cells. Evidence for a negative 
regulatory role of PD-1 comes from studies of PD-1 deficient mice, which develop a variety of 
autoimmune phenotypes.19 These results suggest that PD-1 blockade has the potential to activate 
anti-self T-cell responses, but these responses are variable and dependent upon various host genetic 
factors. Thus, PD-1 deficiency or inhibition is not accompanied by a universal loss of tolerance to 
self-antigens. 
In vitro, nivolumab (BMS-936558) binds to PD-1 with high affinity (EC50 0.39-2.62 nM), and 
inhibits the binding of PD-1 to its ligands PD-L1 and PD-L2 (IC50 ± 1 nM). Nivolumab binds 
specifically to PD-1 and not to related members of the CD28 family such as CD28, ICOS, CTL-4 
and BTLA. Blockade of the PD-1 pathway by nivolumab results in a reproducible enhancement 
of both proliferation and IFN-γ release in the MLR. Using a CMV re-stimulation assay with human 
PBMC, the effect of nivolumab on antigen specific recall response indicates that nivolumab 
augmented IFN-γ secretion from CMV specific memory T cells in a dose-dependent manner versus 
isotype-matched control. In vivo blockade of PD-1 by a murine analog of nivolumab enhances the 
anti-tumor immune response and results in tumor rejection in several immunocompetent mouse 
tumor models (MC38, SA1/NPAN02).20 
3.2.2.3 
Clinical Experience with Nivolumab in NSCLC 
Approval of nivolumab in advanced NSCLC was based on 2 phase 3 trials (CheckMate 017 and 
CheckMate 057) which demonstrated survival benefit over docetaxel across histologies in 
previously treated patients. 
The approval in squamous NSCLC was based on the results of CA209017, a randomized trial of 
nivolumab versus docetaxel. The median OS for patients in the nivolumab arm was 9.2 months 
versus 6 months for those in the docetaxel arm (HR = 0.59). Improvement in survival was observed 
for nivolumab regardless of PD-L1 expression, although there was a trend toward better efficacy 
for those with PD-L1 expressing tumors. A single-arm trial (CA209063) of 117 patients with 
metastatic squamous NSCLC with progression after platinum-based chemotherapy and at least 1 
additional systemic regimen showed a 15% objective response rate (ORR); 59% of participants 
with a response had response durations of 6 months or longer.21 
The approval of nivolumab for the treatment of non-squamous NSCLC is based on a second phase 
3 study, CA209057, which met its primary endpoint of superior OS of nivolumab versus docetaxel 
in patients with previously treated non-squamous NSCLC at a preplanned interim analysis. 

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Patients in the nivolumab arm had a 27% reduction in risk of death (HR = 0.73; P = 0.0015). The 
safety profile was also more favorable for nivolumab vs docetaxel.22 
Although the first-line CA209026 trial did not demonstrate that single agent nivolumab provided 
superior efficacy over platinum doublet chemotherapy, the efficacy of nivolumab was similar to 
that of chemotherapy in this first line patient population.23 
A detailed description of the chemistry, pharmacology, efficacy, and safety of nivolumab is 
provided in the Investigator Brochure and local package insert. 
3.2.3 
Clinical Experience with Nivolumab plus Ipilimumab Combination 
Therapy 
Multiple clinical studies have evaluated nivolumab combined with ipilimumab at different doses 
and schedules across various tumor types. 
CA209012 was a multi-arm phase 1b trial evaluating the safety and tolerability of nivolumab in 
patients with chemotherapy-naïve advanced non-small cell lung cancer (NSCLC), as either 
monotherapy or in combination with other agents including ipilimumab, at different doses and 
schedules. The primary endpoint of the study was safety with secondary endpoints of objective 
response rate (ORR) per RECIST 1.1 and 24-week progression-free survival (PFS). Participants 
were assigned to receive nivolumab 3 mg/kg Q2W + ipilimumab 1 mg/kg Q12W (n=38), 
nivolumab 3 mg/kg Q2W + ipilimumab 1 mg/kg Q6W (n=39) and nivolumab 3 mg/kg Q2W 
(n=52). The confirmed ORR was 47% (N3 Q2W + I1 Q12W), 39% (N3 Q2W + I1 Q6W) and 23% 
(N3 Q2W). 
The rate of treatment-related adverse events (AEs) in the Q12W (82%) and Q6W (72%) arms were 
comparable to monotherapy (72%). In the study, Grade 3/4 adverse events were 37%, 33%, and 
19% for the Q12W, Q6W, and nivolumab monotherapy arms, respectively. Treatment-related 
Grade 3-4 AEs led to discontinuation in 5% and 8% of participants in the Q12W and Q6W cohorts, 
respectively, and were similar to nivolumab monotherapy. There were no treatment-related deaths. 
The treatment-related select AEs in patients administered the optimized dosing schedule (3 mg/kg 
of nivolumab Q2W plus 1 mg/kg of ipilimumab Q6W) were skin related (36%), gastrointestinal 
(23%), endocrine (20%), and pulmonary (5%) and there were ≤ 5% treatment related Grade 3 and 
Grade 4 AEs per category. 
Efficacy and safety profiles were further described with nivolumab combined with ipilimumab in 
the ongoing phase 3 CheckMate 227 study which enrolled patients with stage IV or recurrent 
NSCLC who were not previously treated. Those with a level of tumor PD-L1 expression of at least 
1% were randomly assigned, in a 1:1:1 ratio, to receive nivolumab plus ipilimumab, nivolumab 
monotherapy, or chemotherapy. Those with a tumor PD-L1 expression level of less than 1% were 
randomly assigned, in a 1:1:1 ratio, to receive nivolumab plus ipilimumab, nivolumab plus 
chemotherapy, or chemotherapy. Co-primary endpoints were PFS in patients with a TMB ≥ 10 
mutations/Mb using the FoundationOne CDx assay, and OS in patients with PD-L1 
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In the PFS analysis of patients with high tumor mutational burden (≥ 10 mutations/Mb), PFS was 
significantly longer in the group treated by nivolumab plus ipilimumab compared with 
chemotherapy, demonstrating a median PFS of 7.2 months vs 5.5 months, respectively (HR = 0.58; 
97.5% CI: 0.41, 0.81, P < 0.001), and was numerically better than that of nivolumab alone (HR = 
0.75; 95% CI: 0.53, 1.07).24 
In the OS analysis in patients with PD-L1 expression ≥1%, the combination of nivolumab plus 
ipilimumab significantly prolonged survival compared with chemotherapy, reducing the risk of 
death by 21% (HR = 0.79; 95% CI: 0.65, 0.96).25 The median duration of OS was 17.1 months 
(95% CI: 15.0, 20.1) with nivolumab plus ipilimumab and 14.9 months (95% CI: 12.7, 16.7) with 
chemotherapy (P = 0.007), and 2-year survival rates were 40.0% and 32.8%, respectively. The 
ORR was 35.9% (95% CI: 31.1, 40.8) with nivolumab plus ipilimumab (5.8% of patients had a 
complete response) versus 30.0% (95% CI: 25.5, 34.7) with chemotherapy (1.8% of patients had 
a complete response). The median duration of response was 23.2 months and 6.2 months, 
respectively. The response rate and duration of response for nivolumab monotherapy was 27.5% 
and 15.5 months, respectively, showing the added anti-tumor activity of the nivolumab plus 
ipilimumab combination. An OS benefit was also observed in patients with PD-L1 expression less 
than 1%, with a median survival duration of 17.2 months (95% CI: 12.8, 22.0) with nivolumab 
plus ipilimumab and 12.2 months (95% CI: 9.2, 14.3) with chemotherapy. Across trial participants 
(irrespective of PD-L1 expression), the median duration of OS was 17.1 months (95% CI: 15.2, 
19.9) with nivolumab plus ipilimumab and 13.9 months (95% CI: 12.2, 15.1) with chemotherapy. 
The percentage of patients with grade 3 or 4 treatment-related AE in the overall population was 
32.8% with nivolumab plus ipilimumab and 36.0% with chemotherapy. The overall safety profile 
was consistent with previously reported data, with no new safety signals. 
Overall, the results from the CheckMate 227 trial demonstrate the potential of the nivolumab plus 
ipilimumab combination to improve treatment outcomes in patients with NSCLC, irrespective of 
PD-L1 expression. 
The approval of nivolumab plus ipilimumab plus 2 cycles of chemotherapy in first-line NSCLC 
was based on the results of CA2099LA, a randomized trial of nivolumab 360 mg every 3 weeks 
(Q3W) plus ipilimumab 1 mg/kg Q6W plus 2 cycles of chemotherapy (treatment arm) vs 4 cycles 
of chemotherapy with optional pemetrexed as maintenance (control arm) for non-squamous 
histology. This trial met its primary endpoint of OS at the interim analysis with a minimum follow 
up of 8.1 months (HR = 0.69, 96.71% CI: 0.55, 0.87; p = 0.0006). After a minimum follow up of 
12.7 months, median OS was 15.6 months in the treatment arm, and 10.9 months in the control 
arm, yielding a HR of 0.66 (95% CI: 0.55, 0.80) with OS benefit also observed across prespecified 
subgroups. A PFS advantage was demonstrated in the treatment arm vs control arm with a median 
of 6.7 vs 5.0 months (HR = 0.68; 95% CI: 0.57, 0.82), respectively. A significant improvement in 
ORR was also observed with a response rate of 38% in the treatment arm vs 25% in the control 
arm (Odds Ratio = 1.9, 95% CI: 1.4, 2.6). The safety profile remains consistent with previous 
findings with no new toxicity signals and Grade 3/4 treatment-related AEs rates being 47% in the 
treatment arm and 38% in the control arm.26 

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3.2.4 
Clinical Experience with Nivolumab and CCRT 
The safety, tolerability, and feasibility of administering nivolumab concurrently with CCRT in 
patients with stage III locally advanced NSCLC is supported by data from the Phase 2 NICOLAS 
trial.27 In the NICOLAS trial, participants received 3 cycles of platinum-based chemotherapy 
(cisplatin or carboplatin combined with etoposide, pemetrexed or vinorelbine) concurrently with 
radiotherapy (66 Gy/ 33 fractions) and nivolumab (360 mg every 3 weeks). Radiotherapy 
techniques during CCRT included VMAT, IMRT or 3DRT, with a mean lung dose of < 20 Gy. 
Following CCRT, participants received nivolumab maintenance therapy for up to 1 year at a dose 
of 480 mg every 4 weeks. 
The primary endpoint in the NICOLAS trial was pneumonitis-free rate (Grade ≥ 3) observed at 
any time during 6 months post-radiotherapy. One formal interim safety analysis was performed 
when the first 21 participants reached 3 months post-radiotherapy follow-up. Success at the interim 
analysis would be declared if there were zero Grade ≥ 3 pneumonitis events in the 21 evaluable 
participants. Otherwise, at the final analysis, at least 33 of the 41 participants would be required to 
be Grade ≥ 3 pneumonitis-free at 6 months post-radiotherapy to reject the null hypothesis. 
At the interim analysis (completed in September 2017), zero Grade ≥ 3 pneumonitis events were 
observed, demonstrating the safety and tolerability of nivolumab combined with CCRT. By 
August 2018, 41 evaluable participants reached 6 months post-CCRT follow-up. Thirty-six 
participants had not experienced Grade ≥ 3 pneumonitis, above the boundary for null hypothesis 
rejection of ≥ 33 participants remaining event-free. These results provide additional support for 
the interim analysis conclusion that nivolumab + CCRT is safe and tolerable. 
In this ongoing trial, up to May 2019, data are available for 77 safety-evaluable patients with a 
median follow-up of 20.9 months. In this safety cohort, 8 Grade 3 pneumonitis events were 
reported, 7 of which resolved.28 
Based on the formal interim safety analysis in the first 21 participants, the informal safety 
verification in the first 41 participants, and the incidence of pneumonitis Grade ≥ 3 in the full 
safety cohort of 77 participants, NICOLAS study investigators determined that no unexpected AEs 
or increased safety risk was observed in the trial. 
In part 2 of another phase 2 trial (DETERRED) combining atezolizumab concurrently with 
chemoradiation in locally advanced NSCLC also suggested that PD-L1 blockade given 
concurrently with chemoradiation was feasible and safe.7 The chemotherapy component consisted 
of weekly low dose carboplatin and paclitaxel concurrently with radiotherapy followed by 2 cycles 
of full dose carboplatin/paclitaxel as consolidation. Of the 30 participants who received at least 1 
dose of therapy, 3 participants (10%) reported pneumonitis (two Grade 2 events and one Grade 3 
event). The overall toxicity profile of atezolizumab with CCRT followed by consolidation and 
maintenance atezolizumab was similar to CCRT alone followed by consolidation and maintenance 
atezolizumab. 
In the Keynote 799 study, patients with unresectable, locally advanced, Stage III NSCLC were 
randomized into two cohorts containing pembrolizumab and chemoradiation given concurrently 

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with the chemotherapy component consisting of carboplatin/paclitaxel in Cohort A (N = 112) and 
cisplatin/pemetrexed in Cohort B (N = 73). An ORR of 69.6% (n = 78; 95% CI: 60.2-78.0) in 
Cohort A and 70.5% (n = 43; 95% CI: 57.4-81.5) in Cohort B was observed with an estimated 
response duration of ≥ 12 months in most patients with a response. 1-year OS rates in both cohorts 
were > 80%. Safety results were also consistent with findings in other similar studies. Given a 
median follow up of 8.3 months in Cohort A and 5.8 months in Cohort B, Grade ≥ 3 pneumonitis 
occurred in 9 (8.0%) patients in Cohort A, and in 4 (5.5%) patients in Cohort B.29 
Collectively, the results from the NICOLAS, DETERRED, and Keynote 799 trials support the 
combination of nivolumab with CCRT in the CA20973L trial. 
3.3 
Benefit/Risk Assessment 
Lung cancer has been the most common cancer in the world for several decades and the most 
common cause of death from cancer worldwide. Non-small cell lung cancer (NSCLC) represents 
approximately 80% to 85% of all lung cancers and 30% of patients present with Stage III disease. 
Standard treatment for patients with a good performance status and unresectable Stage III NSCLC 
has been definitive chemoradiation. CCRT as standard of care has a well-established safety profile. 
A meta-analysis of concurrent versus sequential chemoradiotherapy showed better outcomes with 
concurrent therapy.9 
Durvalumab, an anti-PD-L1 agent, showed an improvement in median PFS and OS as maintenance 
therapy in patients who did not experience disease progression after CCRT.2 However, the 
majority of patients still experienced disease progression or death during the first two years of 
therapy (18-month PFS rate of 44.2%), and only 57% of patients were alive at 3 years.4,12 Updated 
analyses at 48 months further observed a decrease in PFS and OS with an estimated rate of 35.3% 
and 49.6%, respectively.3 Therefore, further improvement in cure rate is needed, given this stage 
of disease is potentially curable. In addition, the PACIFIC trial only included patients in whom 
disease had not progressed after CCRT. Mitigating the risk of disease progression on or right after 
CCRT represents another high unmet medical need. Please refer to the approved Product Label for 
durvalumab for additional information. 
Clinical and preclinical data have shown the potential for concurrent administration of 
anti-PD-1/PD-L1 therapy with CCRT to improve clinical outcomes.5,12 Safety data from the 
NICOLAS trial provides evidence for the feasibility of nivolumab 360 mg Q3W given 
concurrently with CCRT, with no increased safety risk.6,27,28 Furthermore, clinical evidence from 
CheckMate 227 supports the potential for the combination of nivolumab and ipilimumab 
maintenance therapy to further improve the cure rate and overall treatment outcomes for patients 
with LA NSCLC.25 
Extensive details on the safety profile of nivolumab and ipilimumab are available in their 
respective Investigator Brochures and will not be repeated herein. 
Overall, the safety profile of nivolumab monotherapy as well as in combination with ipilimumab 
is manageable and generally consistent across completed and ongoing clinical trials with no MTD 

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reached at any dose tested up to 10 mg/kg. Most AEs were low-grade (Grade 1 to 2) with relatively 
few related high-grade (Grade 3 to 4) AEs. There was no pattern in the incidence, severity, or 
causality of AEs with respect to nivolumab dose level. 
A pattern of immune-related adverse events has been defined, for which management algorithms 
for nivolumab and ipilimumab have been developed; these are provided in Appendix 6. Most high- 
grade events were manageable with the use of corticosteroids or hormone replacement therapy 
(endocrinopathies) as instructed in these algorithms. 
Additional details on the safety profile of nivolumab, including results from other clinical studies, 
are also available in the nivolumab IB. 
Bristol-Myers Squibb (BMS) has given consideration regarding the benefit/risk of coronavirus 
disease 2019 (COVID-19) vaccination during participation in BMS clinical trials of nivolumab 
and ipilimumab. Based on the review of current available data and evidence to date, knowledge of 
the mechanisms of action of the COVID-19 vaccines and nivolumab or ipilimumab investigation 
[medicinal] products (IPs/IMPs), a biological or pharmacological interaction occurring between 
the vaccine and the IPs that would negatively impact the benefit/risk for participants in BMS 
clinical trials of nivolumab and ipilimumab is not expected; however, data will continue to be 
reviewed. Therefore, at this time, a COVID-19 vaccine given to participants in this trial is 
considered a concomitant medication with no interaction. 
Non-live COVID-19 vaccination is considered a simple concomitant medication within the study. 
However, the efficacy and safety of non-live vaccines (including non-live COVID-19 vaccines) in 
participants receiving nivolumab or ipilimumab is unknown. 
To assure an ongoing favorable risks/benefit assessment for participants, an independent Data 
Monitoring Committee (DMC) will be utilized to monitor the safety and efficacy of treatments 
throughout the conduct of the trial. Furthermore, quality assurance for radiotherapy will be in place 
to ensure adherence to the radiation plan. 
4 
OBJECTIVES, ENDPOINTS, AND ESTIMANDS 
The study objectives and endpoints described below will be evaluated for the following treatment 
regimens: 
• Arm A: Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance 
• Arm B: Nivolumab + CCRT followed by nivolumab maintenance 
• Arm C: CCRT followed by durvalumab maintenance 
 
Table 4-1: 
Objectives and Endpoints 
 
Objectives 
Endpoints 
Primary 
To compare progression-free survival (PFS) for Arm A 
vs Arm C 
• 
PFS by RECIST 1.1 per BICR 

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Objectives 
Endpoints 
Secondary 
To compare OS for Arm A vs Arm C 
• 
OS for Arm A vs Arm C 
To evaluate PFS and OS for Arm B vs Arm C and Arm A 
vs Arm B 
• 
PFS by RECIST 1.1 per BICR for Arm B vs 
Arm C 
• 
OS for Arm B vs Arm C 
• 
PFS by RECIST 1.1 per BICR for Arm A vs 
Arm B 
• 
OS for Arm A vs Arm B 
To evaluate tumor response for Arm A vs Arm C, Arm B 
vs Arm C, and Arm A vs Arm B according to BICR 
assessment 
• 
Objective Response Rate (ORR) by RECIST 1.1 
per BICR 
• 
Duration of response (DoR) by RECIST 1.1 per 
BICR 
• 
Time to response (TTR) by RECIST 1.1 per 
BICR 
To evaluate PFS and tumor response for Arm A vs Arm 
C, Arm B vs Arm C, and Arm A vs Arm B according to 
Investigator assessment of tumor imaging 
• 
PFS by RECIST 1.1 per Investigator assessment 
• 
ORR by RECIST 1.1 per Investigator 
assessment 
• 
DoR by RECIST 1.1 per Investigator assessment 
• 
TTR by RECIST 1.1 per Investigator assessment 
To evaluate time to death or distant metastases (TTDM) 
for Arm A vs Arm C, Arm B vs Arm C, and Arm A vs 
Arm B according to Investigator assessment of tumor 
imaging 
• 
TTDM by RECIST 1.1 per Investigator 
assessment 
To assess safety and tolerability of study treatments 
• 
Incidence of AEs, SAEs, and select AEs 
To evaluate symptom deterioration for Arm A vs Arm C, 
Arm B vs Arm C, and Arm A vs Arm B 
• 
Proportion of participants without meaningful 
symptom deterioration following 48 weeks of 
maintenance therapy based on NSCLC-SAQ 
Exploratory 
To characterize changes in cancer-related symptoms and 
quality-of-life between treatment arms in participants 
with untreated LA NSCLC 
• 
FACT-L total and sub-scale scores 
• 
NSCLC-SAQ total score and items 
• 
EQ-5D-5L VAS and utility index 
To evaluate psychometric measurement properties of the 
LCS sub-scale of FACT-L and NSCLC-SAQ 
• 
Reliability, validity, and responsiveness of the 
LCS sub-scale of FACT-L and NSCLC-SAQ 
• 
Threshold for clinically meaningful change 
To evaluate the tolerability of study treatments 
• 
Symptomatic adverse events as measured by the 
GP5 item of the FACT-L 
To evaluate investigator-assessed outcomes on next-line 
therapies 
• 
PFS on next line therapy (PFS-2) per 
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Abbreviations: AE, adverse event; BICR, blinded independent central review; 
DoR, duration of response; eCRF, electronic case report form; EQ-5D-5L, 5-level version of 
the EuroQol Group’s EQ-5D; FACT-L, Functional Assessment of Cancer Therapy - Lung; HCRU, healthcare resource 
utilization; LA NSCLC, locally advanced non-small cell lung cancer; LCS, lung cancer subscale; 
NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; ORR, objective response rate; 
OS, overall survival; 
PFS, progression-free survival; PFS-2, progression-free 
survival on next line therapy; PK, pharmacokinetics; RECIST 1.1, Response Evaluation Criteria in Solid Tumors 
version 1.1; TTDM, time to death or distant metastases; TTR, time to response; VAS, visual analog scale. 
 
4.1 
Estimand for Primary Objective 
The main estimand corresponding to the primary objective is stratified hazard ratio in PFS by 
RECIST 1.1 per blinded independent central review (BICR) between nivolumab + CCRT followed 
by maintenance therapy with nivolumab + ipilimumab (Arm A) vs CCRT followed by 
maintenance therapy with durvalumab (Arm C) in patients with previously untreated, locally 
advanced Stage IIIA/IIIB/IIIC NSCLC, irrespective of initiation of subsequent anti-cancer 
therapy. 
The supplemental estimand corresponding to the primary objective is stratified hazard ratio in PFS 
by RECIST 1.1 per BICR between nivolumab + CCRT followed by maintenance therapy with 
nivolumab + ipilimumab (Arm A) vs CCRT followed by maintenance therapy with durvalumab 
(Arm C) in patients with previously untreated, locally advanced Stage IIIA/IIIB/IIIC NSCLC, 
accounting for initiation of subsequent anti-cancer therapy. 
The following tables Table 4.1-1 and Table 4.1-2 list the attributes of the main estimand and 
supplemental estimand for the primary objective. 
Objectives 
Endpoints 
To characterize the pharmacokinetics (PK) of ipilimumab 
and nivolumab when administered in combination or for 
nivolumab when administered as monotherapy 
• 
PK parameters 
To assess immunogenicity of nivolumab monotherapy 
and nivolumab and ipilimumab combination therapy 
• 
Incidence of anti-drug antibodies against 
ipilimumab and nivolumab when administered 
in combination or against nivolumab when 
administered as monotherapy 
To assess healthcare resource utilization (HCRU) in each 
treatment arm 
• 
Incidence of HCRU (eg, hospital admissions, 
number of days, discharge diagnosis, date of 
visits, etc) as documented in eCRF 

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Table 4.1-1: 
Summary of Attributes of the Main Estimand for Primary 
Objective 
 
Attribute 
Definition Details 
Treatment 
Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance vs CCRT followed 
by durvalumab maintenance 
Population 
Patients with previously untreated locally advanced Stage IIIA/IIIB/IIIC NSCLC 
Variable 
PFS by RECIST 1.1 per BICR, defined as the time between the date of randomization and 
the date of first documented tumor progression, based on BICR assessments (per RECIST 
v1.1), or death due to any cause, whichever occurs first 
Intercurrent 
Events (ICEs) 
Event 
Strategy 
Description 
Premature discontinuation 
of study therapy 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of PD or death irrespective of 
treatment discontinuation 
Subsequent anti-cancer 
therapy prior to PD or 
death 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of PD or death irrespective of 
initiation of subsequent therapy 
Population-level 
Summary 
Hazard ratio estimated by stratified Cox proportional hazard model 
Abbreviations: BICR, blinded independent central review; CCRT, concurrent chemoradiotherapy; ICE, intercurrent 
event; NSCLC, non-small cell lung cancer; PD, progressive disease; PFS, progression-free survival; RECIST 1.1, 
Response Evaluation Criteria in Solid Tumors version 1.1. 
 
Table 4.1-2: 
Summary of Attributes of the Supplemental Estimand for Primary 
Objective 
 
Attribute 
Definition Details 
Treatment 
Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance vs CCRT followed 
by durvalumab maintenance 
Population 
Patients with previously untreated locally advanced Stage IIIA/IIIB/IIIC NSCLC 
Variable 
PFS by RECIST 1.1 per BICR, defined as the time between the date of randomization and 
the date of first documented tumor progression, based on BICR assessments (per RECIST 
v1.1), or death due to any cause, whichever occurs first 
Intercurrent 
Events (ICEs) 
Event 
Strategy 
Description 
Premature discontinuation 
of study therapy 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of PD or death irrespective of 
treatment discontinuation 
Subsequent anti-cancer 
therapy prior to PD or 
death 
Hypothetical 
strategy 
Participants are censored at the last 
evaluable tumor assessment prior to the 
start of subsequent anti-cancer therapy 
Population-level 
Summary 
Hazard ratio estimated by stratified Cox proportional hazard model 
Abbreviations: BICR, blinded independent central review; CCRT, concurrent chemoradiotherapy; ICE, intercurrent 
event; NSCLC, non-small cell lung cancer; PD, progressive disease; PFS, progression-free survival; RECIST 1.1, 
Response Evaluation Criteria in Solid Tumors version 1.1. 

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4.2 
Estimand for Key Secondary Objective 
The main estimands corresponding to the key secondary objectives are stratified hazard ratio in 
OS between nivolumab + CCRT followed by maintenance therapy with nivolumab + ipilimumab 
(Arm A) vs CCRT followed by maintenance therapy with durvalumab (Arm C), and nivolumab + 
CCRT followed by maintenance therapy with nivolumab (Arm B) vs CCRT followed by 
maintenance therapy with durvalumab (Arm C) in patients with previously untreated locally 
advanced Stage IIIA/IIIB/IIIC NSCLC. 
Table 4.2-1: 
Summary of Attributes of the Main Estimand for Secondary 
Objective (Arm A vs Arm C) 
 
Attribute 
Definition Details 
Treatment 
Nivolumab + CCRT followed by nivolumab + ipilimumab maintenance vs CCRT followed 
by durvalumab maintenance 
Population 
Patients with previously untreated locally advanced Stage IIIA/IIIB/IIIC NSCLC 
Variable 
OS, defined as the time between the date of randomization and the date of death due to any 
cause 
Intercurrent 
Events (ICEs) 
Event 
Strategy 
Description 
Premature discontinuation 
of study therapy 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of death regardless of treatment 
discontinuation 
Subsequent anti-cancer 
therapy prior to death 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of death irrespective of 
subsequent anti-cancer therapy 
Lost to follow-up 
While on 
treatment strategy 
Participants are censored at last known 
alive date 
Population-level 
Summary 
Hazard ratio estimated by stratified Cox proportional hazard model 
Abbreviations: CCRT, concurrent chemoradiotherapy; ICE, intercurrent event; NSCLC, non-small cell lung cancer; 
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Table 4.2-2: 
Summary of Attributes of the Main Estimand for Secondary 
Objective (Arm B vs Arm C) 
 
Attribute 
Definition Details 
Treatment 
Nivolumab + CCRT followed by nivolumab maintenance vs CCRT followed by 
durvalumab maintenance 
Population 
Patients with previously untreated locally advanced Stage IIIA/IIIB/IIIC NSCLC 
Variable 
OS, defined as the time between the date of randomization and the date of death due to any 
cause 
Intercurrent 
Events (ICEs) 
Event 
Strategy 
Description 
Premature discontinuation 
of study therapy 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of death irrespective of 
treatment discontinuation 
Subsequent anti-cancer 
therapy prior to death 
Treatment policy 
strategy 
Disregard the intercurrent event and use 
the time of death irrespective of 
subsequent anti-cancer therapy 
Lost to follow-up 
While on 
treatment strategy 
Participants are censored at last known 
alive date 
Population-level 
Summary 
Hazard ratio estimated by stratified Cox proportional hazard model 
Abbreviations: CCRT, concurrent chemoradiotherapy; ICE, intercurrent event; NSCLC, non-small cell lung cancer; 
OS, overall survival. 
 
5 
STUDY DESIGN 
5.1 
Overall Design 
This is a multicenter, randomized, open-label, Phase 3 study to compare nivolumab plus CCRT 
followed by nivolumab and ipilimumab combination (Arm A) or nivolumab plus CCRT followed 
by nivolumab alone (Arm B) with CCRT followed by durvalumab (Arm C) in previously untreated 
LA NSCLC. The safety and efficacy of ipilimumab added to nivolumab maintenance therapy will 
also be characterized by evaluating Arm A vs Arm B descriptively. 
The study is divided into a Screening Period, a Concurrent Chemoradiotherapy (CCRT) Period, a 
Recovery Period, a Maintenance Period, and a Long-term Follow-up Period. The treatment period 
will contain a CCRT Period, a Recovery Period, and a Maintenance Period. 
Participants will be randomized (1:1:1) across 3 treatment arms: 
• Arm A: 
− CCRT Period: Nivolumab (360 mg flat dose IV Q3W) for cycles 1 to 3 + platinum doublet 
chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy (total dose of 60-66 Gy) for 
cycles 2 to 3 
− Maintenance Period: Nivolumab (360 mg flat dose IV Q3W) + ipilimumab (1 mg/kg IV 
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• Arm B: 
− CCRT Period: Nivolumab (360 mg flat dose IV Q3W) for cycles 1 to 3 + platinum doublet 
chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy (total dose of 60-66 Gy) for cycles 
2 to 3 
− Maintenance Period: Nivolumab (480 mg flat dose IV Q4W) for up to 12 months 
• Arm C: 
− CCRT Period: Platinum doublet chemotherapy (IV Q3W) for cycles 1 to 3 + radiotherapy 
(total dose of 60-66 Gy) for cycles 2 to 3 
− Maintenance Period: Durvalumab (10 mg/kg IV Q2W) for up to 12 months 
 
If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 
of the CCRT Period (Arms A, B, or C), the investigator has the option to skip Cycle 1 of systemic 
anticancer therapy alone and initiate treatment with radiotherapy concurrently with systemic 
anticancer therapy (Cycle 2). All study procedures for Cycle 2 and Cycle 3 during the CCRT 
Period are still to be followed. The Recovery Period will begin after the final dose of radiotherapy 
and the completion of Cycle 3 procedures as outlined in the Schedule of Activities. An additional 
cycle of consolidation chemotherapy + nivolumab (Arms A and B) or chemotherapy alone 
(Arm C) will not be administered after the completion of radiotherapy in this situation. 
• Randomization will be stratified by: 
• Age: 
− < 65 years 
− ≥ 65 years 
• Tumor PD-L1 status: 
− ≥ 1% 
− < 1% 
− indeterminate or not evaluable 
• Stage (per AJCC 8th edition): 
− IIIA 
− IIIB 
− IIIC 
 
The proportions of participants with indeterminate or not evaluable tumor PD-L1 status will be 
monitored and reassessed as needed to ensure that the sample size in this stratum is adequate for 
analysis. Details will be described in the statistical analysis plan. 
The study design schematic is presented in Figure 5.1-1. 

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Figure 5.1-1: 
Study Design Schematic 
 
Abbreviations: BICR, blinded independent central review; CCRT, concurrent chemoradiotherapy; ECOG, Eastern 
Cooperative Oncology Group; N, number of participants; NSCLC, non-small cell lung cancer; PD, progressive 
disease; PD-L1, programmed death-ligand 1; PFS, progression-free survival; Q2W, every 2 weeks; Q3W, every 3 
weeks; Q4W, every 4 weeks; Q6W, every 6 weeks; R, randomize; RT, radiotherapy. 
 
5.1.1 
Screening Period 
Participants will provide written informed consent (ICF) to participate in the study before 
completing any protocol-specified procedures or evaluations not considered to be part of the 
participant’s standard care. After signing the ICF, participants will be evaluated for entry criteria 
during the Screening Period within 28 days before randomization. Re-enrollment after screen 
failure will be allowed. Tumor imaging during Screening will include whole body PET/CT 
(including contrast) of the base of the skull through the upper thighs, within 28 days prior to 
randomization. PET component can be performed within 42 days prior to randomization. A 
separate contrast enhanced CT of chest, CT or MRI of upper abdomen (including adrenal glands, 
and full liver), and other suspected sites of disease is required if the CT component of the PET/CT 
is not of sufficient diagnostic quality for RECIST 1.1 assessments. Imaging of the brain with MRI 
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randomization. CT of the brain (without and with contrast) can be performed if MRI is 
contraindicated or based on Investigator discretion. 
All participants must have tissue submitted during screening. See Section 6.1 (Inclusion Criteria) 
and Section 9.8 (Biomarkers) for specifications. Sufficient, recent tumor tissue obtained within 
3 months prior to enrollment from a tumor lesion (formalin-fixed, paraffin-embedded block or 5 
to 10 unstained slides, obtained from core biopsy, excisional biopsy or surgical specimen) will be 
submitted to the central laboratory along with an associated pathology report. Fine needle 
aspiration is unacceptable for submission. In order for the participants to be treated, the sample 
must be submitted to the central laboratory for the PD-L1 test, and the PD-L1 status must be 
available to IRT prior to randomization. PD-L1 testing will be performed using the validated 
Agilent/Dako PD-L1 IHC 28-8 pharmDx assay. Participants should not have received any local or 
systemic anticancer therapy after the date that the submitted tumor tissue was obtained. 
Clinical TNM staging should be performed per major guidelines (eg, ESMO, NCCN). Participants 
must be evaluated by the site’s multidisciplinary team (eg, medical oncologist, surgeon, radiologist) 
during screening to assess the suitability of the participant for the study. 
Except for overt cT4 disease, nodal status N2 or N3 must be proven by biopsy in at least one N2 
or N3 node via endobronchial ultrasound (EBUS), mediastinoscopy, or thoracoscopy. In addition, 
T3N1 status must be proven in at least one N1 node (if lesion amenable or medically feasible) via 
one of these modalities. See Appendix 8 for summary for recommendations for nodal GTV 
delineation. 
5.1.2 
CCRT Period 
Participants in all arms will receive CCRT. Participants in Arm A and Arm B will receive the 
addition of nivolumab concurrently with CCRT; whereas participants in Arm C will receive CCRT 
alone during the CCRT Period. After randomization, participants must commence systemic study 
treatments (chemotherapy ± nivolumab) within 7 days. 
Chemotherapy consists of up to 3 cycles of platinum-based doublet treatment, administered in 
3-week cycles (Cycles 1 to 3). Prior to randomization, the planned chemotherapy regimen, the 
planned number of cycles of chemotherapy (up to 2 cycles or up to 3 cycles), the planned dose 
level of chemotherapy at the start of treatment for agents with more than 1 possible dose level per 
protocol (e.g. carboplatin, paclitaxel), and the radiation modality must be pre-defined and 
documented in the IRT and medical records by the investigator. Please note that if the actual 
treatment regimen administered to the participant during the CCRT Period changes from the 
planned regimen documented in the IRT prior to randomization, the rationale for the change must 
also be recorded in the case report form (CRF) and documented in the medical record. Participants 
with tumor of squamous histology will receive etoposide/cisplatin or paclitaxel/carboplatin. 
Participants with tumor of non-squamous histology will receive either etoposide/cisplatin, 
paclitaxel/carboplatin, or pemetrexed/cisplatin. If cisplatin cannot be tolerated, cisplatin may be 
replaced with carboplatin and the rationale must be documented in the CRF and medical record. 
If pemetrexed cannot be tolerated, pemetrexed may be replaced with etoposide and the rationale 
must be documented in the CRF and medical record. Recommended dose modification schedule 

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(Section 7.4.5) should be followed; however, local standards and clinical judgment should be used 
for individual cases. 
Radiotherapy starts on the first day of Cycle 2 of chemotherapy and consists of a target physical 
dose of 60-66 Gy in 30-33 daily fractions of 2 Gy (typically on a 5 days on/2 days off schedule as 
appropriate, 
over 
6-7 
weeks) 
by 
intensity-modulated 
radiation 
therapy 
(IMRT), 
volumetric-modulated arc therapy (VMAT), or 3-dimentional RT (3DRT). It is recommended that 
radiotherapy be administered on the same day and after the completion of systemic anticancer 
therapy. If logistically infeasible, a window of ± 3 days is permitted. In case the administration of 
systemic anticancer therapy must be delayed due to toxicity, radiotherapy must start ± 3 days of 
the start of systemic anticancer therapy in Cycle 2. 
If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 
of the CCRT period (Arms A, B, or C), the investigator has the option to skip Cycle 1 of systemic 
anticancer therapy alone, and initiate treatment with radiotherapy concurrently with systemic 
anticancer therapy (Cycle 2). All study procedures for Cycle 2 and Cycle 3 during the CCRT period 
are still to be followed. An additional cycle of consolidation systemic anticancer therapy will not 
be administered after the completion of radiotherapy in this situation. 
Sites must be equipped and qualified to deliver standard of care radiotherapy concurrent with 
systemic anticancer therapy. Radiotherapy will be subject to a QA process. This will involve site 
qualification/credentialization and real time review of radiotherapy plans with real time feedback 
to sites. Upon completion of radiotherapy, all data must be submitted for final analysis. QA 
services will be provided by an external vendor who will provide a separate radiotherapy manual 
to describe detailed radiotherapy requirements and QA processes. 
In Arm A and Arm B, nivolumab 360 mg IV Q3W for up to 3 cycles (Cycles 1 to 3) will be given 
concurrently to chemotherapy or chemoradiotherapy, starting on the first day of each cycle and 
must be given prior to the administration of chemotherapy. It is also recommended that nivolumab 
be given prior to radiotherapy on the same day if logistically feasible. 
Every effort should be made to continue radiotherapy during the CCRT Period in an uninterrupted 
manner. In case of severe toxicities, such as high-grade esophagitis necessitating interruption of 
systemic anticancer therapy, radiotherapy may continue as appropriate provided the investigator 
believes supportive care will enable the participant to complete this part of therapy without 
excessive risk. Additional details are included in chemotherapy and radiotherapy toxicity 
management sections of the protocol (Sections 7.4.5 and 7.6). Compliance will be documented in 
the eCRF. 
Participants who have confirmed disease progression by blinded independent central review 
(BICR) during the CCRT Period will be discontinued from the treatment and enter the Follow-up 
Period. However, all study treatment decisions will be based on the investigator’s assessment of 
tumor images. In case of premature discontinuation of CCRT with reasons other than PD, as 
confirmed by BICR, continuation of the participant into the recovery period may be considered 
based on discussion with the Medical Monitor and Investigator. 

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5.1.3 
Recovery Period 
Recovery Period lasts approximately 3 weeks up to 6 weeks from the end of the CCRT Period (ie, 
last dose of radiotherapy). For participants who are recovering from toxicities associated with 
CCRT treatment, the first dose of maintenance immunotherapy may be delayed up to 6 weeks 
from the end of CCRT (ie, last dose of radiotherapy). If further delay (> 6 weeks) is needed, 
approval by medical monitor or designee is required to move on to the maintenance period, and 
this must be documented in the participant’s medical record. 
Tumor measurement imaging, safety evaluations, and other procedures should be performed 
approximately 3 weeks following the completion of CCRT (ie, last dose of radiotherapy). Tumor 
imaging during the Recovery Period will be the first on-treatment scan for the study. Other 
examinations during the Recovery Period should be performed as close as possible to the 
anticipated commencement of maintenance immunotherapy. 
The maintenance immunotherapy begins when the investigator determines that the participant has 
recovered from the effects of the combined modality treatment sufficiently. For entry into the 
Maintenance Period, participants must meet all eligibility criteria detailed in Section 6.1.2. 
Participants receiving pemetrexed during the CCRT Period should continue their scheduled folic 
acid until 21 days after the last dose of pemetrexed or per local standard. 
Participants who do not meet any criteria of initiating maintenance immunotherapy should proceed 
to the Follow-up Period. 
5.1.4 
Maintenance Period 
Maintenance Period lasts for up to 12 months of treatment for Arm A, Arm B, and Arm C. The 
first dosing in maintenance can be initiated within 2 weeks from the end of CCRT (ie, last dose of 
radiotherapy) but no less than 18 days from the previous dosing of nivolumab (Arm A and B) and 
should be given within 3 calendar days from completion of the last visit in the Recovery Period 
provided eligibility criteria are met. 
Maintenance Period of the study consists of multiple treatment cycles with associated evaluations 
and procedures specified in Table 2-5, Table 2-6, and Table 2-7. One cycle of treatment is defined 
as 6 weeks for Arm A, as 4 weeks for Arm B, or as 2 weeks for Arm C. Every effort should be 
made to schedule visits within the protocol-specified windows. 
Contrast enhanced CT of chest, CT or MRI of upper abdomen (including adrenal glands, full liver), 
and other suspected sites of disease should be performed 24 weeks (± 7 days) from randomization, 
then every 12 weeks (±7 days) during treatment according to Table 2-5, Table 2-6, and Table 2-7. 
Tumor imaging should be submitted to BICR on an ongoing basis. In the case of PD as assessed 
by the investigator (per RECIST 1.1), the images and any associated documentation should be 
submitted to BICR for independent review of progression. Tumor assessment imaging should 
continue per protocol schedule and be submitted to BICR until progression is confirmed by BICR, 
regardless of the start of subsequent anticancer therapies. Furthermore, if the PD is assessed as 
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the Sponsor. 
according to the protocol schedule until distant metastasis is assessed by the Investigator (per 
RECIST 1.1). These images do not need to be submitted to BICR for review. 
Participants will be treated until Investigator-assessed disease progression, death, unacceptable 
toxicity, symptomatic deterioration, the Investigator’s decision to discontinue treatment, 
withdrawal of consent on further treatment, lost to follow-up, BMS decision to terminate the study, 
or completion of required treatment in the Maintenance Period. Additional assessments may occur 
when the decision is made to discontinue treatment. 
In certain circumstances, participants with PD per RECIST 1.1, but with otherwise stable or 
improved performance and clinical status, may continue to be treated in the event of a perceived 
benefit per Investigator; see Section 8.1.6 for treatment beyond progression criteria. 
Participants who cannot complete planned maintenance therapy should enter the Follow-up Period. 
BMS may request that survival data be collected on all participants on treatment in the CCRT 
Period, Recovery Period, or Maintenance Period, if applicable. At the time of this request, each 
participant will be contacted to determine his/her survival status unless the participant has 
withdrawn consent for all contact. 
5.1.5 
Follow Up Period 
Long-term follow-up should continue until withdrawal of consent, death, or study termination by 
Timing for long-term follow-up will be as follows: 
Assessments should continue as described in Table 2-8. 
Safety Follow up: Participants must be followed for safety for at least 100 days after the last dose 
of study treatment. Safety Follow-up Visit 1 should occur 30 days from the last dose (± 7 days). If 
participant delays treatment and later discontinues treatment > 42 days from the last treatment, the 
Safety Follow-up Visit 1 may be performed at time of discontinuation. Safety Follow-up Visit 2 
occurs approximately 100 days (± 7 days) from the last dose of study treatment. Both follow-up 
visits should be conducted in person. If the participant discontinues study treatment for a clinically 
significant AE, the participant will be followed until resolution of the AE or the event is considered 
to be stable and/or chronic. 
Survival Follow Up: Post the Safety Follow up, all participants will be contacted for survival 
every 3 months (± 14 days), by visit (if due for tumor assessments) or phone contact by 
Investigator’s discretion. BMS may request that survival data be collected on all treated 
participants outside of the 3 month specified window. At the time of this request, each participant 
will be contacted to determine his/her survival status unless the participant has withdrawn consent 
for all contact. Tumor assessments should be performed as outlined in Table 2-8. Information on 
the subsequent PD, subsequent anticancer therapy, and outcome must be collected. Subsequent PD 
assessment takes participant status at the initial PD as re-baseline, is defined per local standard 

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practice, and may entail radiological PD, clinical PD, or other. In addition, outcome measures will 
be collected based on Section 9.1.2. 
5.1.6 
Optional Retreatment during Follow-up Period in Arm A and Arm B 
After completing 12 months of Maintenance Period treatment, retreatment is allowed for 
participants in Arm A and Arm B. Participants must have entered the Follow-up Period with 
ongoing disease control (CR, PR, or SD) and without history of treatment beyond progression. 
After BICR-confirmed PD during the Follow-up Period and at the discretion of the investigator, 
participants will be treated with the same maintenance dose and schedule from randomization. For 
Arm A, participants may be retreated with only nivolumab, if ipilimumab was not tolerated. 
Ipilimumab monotherapy is not allowed during retreatment. The maximum duration of retreatment 
is up to 1 year and retreatment is allowed only one time for both Arm A and Arm B. 
Before retreatment, 
• participants must not meet dose delay criteria for nivolumab (see Section 7.4.1) or ipilimumab 
(see Section 7.4.2). 
• participants must not have been treated with any anticancer therapy during the Follow-up 
Period. 
• participants must not have clinical conditions that require urgent medical interventions. 
• participants must be re-consented before initiation of retreatment. 
 
At retreatment, 
• participants must have a baseline tumor assessment within 28 days before the first dose of 
retreatment. 
• participants will have tumor assessments every 12 weeks (± 7 days) from BICR confirmed 
initial disease progression (starting from date of scan). Scans during the Retreatment Period do 
not need to be submitted to BICR. The assessment of PD during the Retreatment Period will 
be per investigator’s assessment using RECIST 1.1. 
• participants without Investigator-assessed distant metastases must continue tumor imaging 
during the Retreatment Period until metastasis is assessed by the Investigator. 
• participants will follow study procedures outlined in Table 2-9 (Arm A) and in Table 2-10 
(Arm B). 
 
Participants who complete or discontinue retreatment must complete assessments for Safety 
Follow-up Visit 1, Safety Follow-up Visit 2, and Survival Follow-up (see Table 2-8). 
5.1.7 
Data Monitoring Committee and Other External Committees 
5.1.7.1 
Data Monitoring Committee 
A Data Monitoring Committee has been established to provide oversight of safety and efficacy 
considerations in protocol CA20973L and to provide advice to the Sponsor regarding actions the 
committee deems necessary for the continued protection of participants enrolled in the study. The 
DMC will be charged with assessing such actions in light of an acceptable benefit/risk profile for 

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nivolumab given concurrently with CCRT as well as in combination with ipilimumab. The DMC 
will act in an advisory capacity to BMS and will monitor participant safety and evaluate the 
available efficacy data for the study. The oncology therapeutic area of BMS has primary 
responsibility for design and conduct of the study. 
When required, adjudicated events will be submitted to the DMC and Health Authorities for review 
on a specified timeframe in accordance with the adjudication documentation. 
Additional details concerning DMC oversight are provided in the DMC charter. 
5.1.8 
Radiotherapy Quality Assurance and Quality Control 
A designated vendor will credentialize sites including the use of a mock case prior to enrollment 
of the first participant at each site. Furthermore, the vendor will perform real-time review of the 
radiation plan for the first enrolled participant and provide feedback to the site within 3 days. 
Treatment will not be delayed, but adjustment of radiation plan may be made as a result of quality 
review. All participants will have their radiation plans and actual delivery reviewed for the purpose 
of measuring compliance to protocolled radiation prescription. The RT quality assurance (QA) and 
quality control (QC) data submission requirements and protocol compliance criteria are detailed 
in the RT QA & QC manual. 
5.2 
Number of Participants 
It is expected that approximately 1400 participants will be screened in order to randomize 
888 participants with previously untreated locally advanced NSCLC, assuming a screen failure 
rate of approximately 40%. Participants will be randomized (1:1:1) into 1 of the 3 treatment arms 
(Section 5.1). 
5.3 
End of Study Definition 
The start of the trial is defined as the first participant’s first visit. End of trial is defined as the last 
participant’s last study visit or last survival assessment/confirmation. The total duration of the 
study is up to 5 years from randomization of the last participant, or until the time of final OS 
analysis, whichever occurs later. 
5.4 
Scientific Rationale for Study Design 
5.4.1 
Rationale for Study Population and Study Comparator 
This study will evaluate the potential for CCRT + nivolumab followed by nivolumab with/without 
ipilimumab to improve treatment outcomes compared with CCRT followed by durvalumab for 
participants with previously untreated, locally advanced Stage IIIA, IIIB, or IIIC NSCLC. 
Participants will be enrolled if their NSCLC is amenable to treatment with definitive CCRT. 
Participants who are not planned for potential curative surgical resection will be eligible. Please 
refer to Section 6.1 for detailed eligibility requirements. 
Durvalumab, an anti-PD-L1 agent, showed an improvement in median PFS and OS as maintenance 
therapy in patients who did not experience disease progression after CCRT (PACIFIC trial).2 
CCRT followed by durvalumab is becoming the new standard of care. However, the majority of 
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(18-month PFS rate of 44.2%), and only 57% of patients were alive at 3 years.4,12 Updated analyses 
at 48 months further observed a decrease in PFS and OS with an estimated rate of 35.3% and 
49.6%, respectively.3 Therefore, new treatment strategies are needed, given this stage of disease 
is potentially curable. In addition, the PACIFIC study only included patients whose disease had 
not progressed after CCRT. Mitigating the risk of disease progression on or right after CCRT 
represents another high unmet medical need. 
5.4.2 
Rationale of Combining Nivolumab with CCRT 
Clinical evidence suggests that the combination of checkpoint inhibitors and radiotherapy may be 
beneficial. In a secondary analysis of KEYNOTE-001, a phase I trial of pembrolizumab, patients 
who received radiotherapy followed by pembrolizumab experienced significantly longer 
progression-free survival and overall survival than did those who had not undergone radiotherapy 
before anti-PD-1 therapy.30 Mechanistically, radiation, acting as an in-situ tumor vaccine, releases 
tumor antigens and helps their presentation to dendritic cells, thus, modulating the immune system 
and helping to mount an immune response against the tumor.31 Radiation also provides a pro- 
immunogenic effect on the tumor microenvironment.32 Consistently, radiotherapy led to PD-L1 
upregulation in tumor cells which was observed in a mouse model, as well as in patients.5,33 This 
upregulation of PD-L1 was mediated by interferon gamma produced by CD8+ T cell blockade of 
PD-1/PD-L1, which enhanced the efficacy of radiotherapy. 
Similarly, chemotherapy may modulate the tumor/immune system interaction in favor of the 
immune system. Chemotherapy can result in tumor cell death with a resultant increase in tumor 
antigen delivery to antigen-presenting cells. Tumor cell death may also lead to a reduction in 
soluble and membrane-bound factors inhibiting tumor-infiltrating T-cells. Chemotherapy may also 
disrupt immune system regulatory networks by decreasing numbers of T-regulatory cells. 
Consistently, chemotherapy may induce PD-L1 expression, which relates to cancer 
immunoresistance.34 
Taken together, combining PD-1/PD-L1 blockade with chemoradiation has the potential to 
orchestrate multi-dimensional anti-tumor activities and maintain a pro-immunogenic tumor 
microenvironment, to improve clinical outcomes in untreated stage III NSCLC. 
5.4.3 
Rationale of Incorporating Ipilimumab into Radiotherapy-based 
Strategy 
Supportive evidence of incorporating ipilimumab into a radiotherapy-based approach mainly 
comes from the metastatic, refractory, and palliative settings. Abscopal effect (ie, anti-tumor 
effects that occur outside the radiation field) was first described in 195335 and before the advent 
of immunotherapy. Recently, an anecdotal case of a durable complete abscopal response to 
palliative radiotherapy and ipilimumab in a patient with metastatic NSCLC was reported.36 Similar 
clinical findings continue to accumulate in NSCLC and other tumor types. 37 Data from a 
prospective phase 2 trial to evaluate radiotherapy and ipilimumab in chemo-refractory metastatic 
NSCLC indicate an ORR of 18% (7/39) with 2 CR, in addition, 5 patients had SD, leading to a 
DCR of 31%. At median follow-up of 43 months, median OS was 7.4 months for the entire cohort, 

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whereas it was 20.4 months for participants who achieved disease control.38 Thus, incorporating 
ipilimumab into radiotherapy-based treatment may also improve outcomes in earlier stages of 
disease (such as, untreated locally advanced NSCLC). 
5.4.4 
Rationale of Concurrent Scheduling of Nivolumab with CCRT 
The optimal schedule for combining checkpoint blockade and chemoradiation is still unknown. In 
the PACIFIC trial, durvalumab was given after the completion of CCRT. In subgroup analyses, 
more pronounced improvement in median PFS was seen in patients randomized within 14 days of 
the last radiation dose than in those randomized later, suggesting that initiating PD-1/PD-L1 
blockade closer to CCRT may be beneficial. 
In a mouse model, different combination schedules were assessed. It was observed that initiating 
PD-1/PD-L1 blockade during radiotherapy lead to longer survival times, whereas starting 
PD-1/PD-L1 blockade 7 days after the completion of radiotherapy yielded similar survival results 
when compared with radiotherapy alone.5 This might be due to an acute increase in PD-L1 
expression on tumor cells during radiotherapy; ineffective PD-1/PD-L1 blockade when given in a 
delayed manner might be explained by the deletion or anergy of tumor-reactive CD8+ cells. 
Safety and tolerability may be of concern when further intensifying CCRT by adding 
immunotherapy. Data from the phase 2 NICOLAS study, designed to evaluate the safety and 
feasibility of nivolumab given concurrently with CCRT, demonstrated that this combination was 
well tolerated. Results showed no major increase in prohibitive toxicity including pneumonitis.24 
Two phase 2 trials combining atezolizumab and pembrolizumab, respectively, concurrently with 
chemoradiation in locally advanced NSCLC also suggested that PD-L1 blockade given 
concurrently with chemoradiation was feasible and safe.7,29 
Therefore, concurrent scheduling of nivolumab with CCRT may offer enhanced efficacy with an 
acceptable toxicity profile. 
5.4.5 
Rationale of Duration of Maintenance Therapy 
Durvalumab, the control treatment in the CA20973L trial, was approved for 1 year of therapy 
following CCRT and is becoming the new standard of care. Therefore, a 1-year maintenance 
duration is opted for in all study arms in the CA20973L trial. Nivolumab (with or without 
ipilimumab) will be administered for a duration of up to 1 year in alignment with the comparator, 
durvalumab. 
5.4.6 
Rationale of Backbone CCRT 
The standard dose-fractionation of radiation in unresectable stage III NSCLC is 60-66 Gy, given 
in fractions of 2 Gy once per day over 30-33 days during definitive CCRT. 
The ideal concurrent chemotherapy regimen has not been determined. The most common regimens 
are cisplatin/etoposide and carboplatin/paclitaxel in ASCO endorsed ASTRO recommendation, 
whereas in ESMO recommendation, cisplatin/etoposide and cisplatin/vinca alkaloid were 
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In the PROCLAIM trial in which pemetrexed/cisplatin was compared with etoposide/cisplatin in 
the context of concurrent chemoradiation, pemetrexed/cisplatin failed to show an improvement in 
OS; however, high grade drug related toxicities were less with pemetrexed/cisplatin.10 In addition, 
the ongoing phase 2 NICOLAS trial suggested that nivolumab given concurrently with CCRT 
containing cisplatin/etoposide, cisplatin/vinorelbine, or cisplatin/pemetrexed was well tolerated.6 
A 
phase 
2 
trial 
combining 
atezolizumab 
concurrently 
with 
chemoradiation 
with 
carboplatin/paclitaxel as the chemotherapy component in locally advanced NSCLC also suggested 
that PD-L1 blockade given concurrently with chemoradiation was feasible and safe.7 Similar 
findings were also obtained from a phase 2 trial with pembrolizumab given concurrently with 
chemoradiation using carboplatin/paclitaxel (Cohort A) or cisplatin/pemetrexed (Cohort B) as the 
chemotherapy component (Section 3.2.4).29 Therefore, cisplatin/etoposide, carboplatin/paclitaxel, 
and cisplatin/pemetrexed have been selected as concurrent chemotherapy options for the 
CA20973L trial. 
Chemotherapy is generally given in 2 to 4 cycles and up to 3 cycles in the phase 2 NICOLAS trial. 
In the CA20973L trial, systemic therapy (chemotherapy ± nivolumab) will start at Cycle 1 in the 
CCRT Period and be administered for up to 3 cycles (Cycles 1 to 3). Radiotherapy will start at 
Cycle 2 and be administered for Cycles 2 to 3. However, if radiotherapy planning is complete prior 
to the initiation of systemic treatment at Cycle 1 of the CCRT period (Arms A, B, or C), the 
investigator has the option to skip Cycle 1 of systemic therapy alone, and initiate treatment with 
radiotherapy concurrently with systemic therapy (Cycle 2). All study procedures for Cycle 2 and 
Cycle 3 during the CCRT period are still to be followed. There is no clinical evidence supporting 
further consolidation therapy, 41 and as such, an additional cycle of consolidation systemic 
anticancer therapy will not be administered after the completion of radiotherapy if Cycle 1 is 
skipped. 
5.4.7 
Rationale for Open-Label Design 
Immune related toxicities require early recognition and prompt intervention with special 
management algorithms. Furthermore, PFS and other key tumor response-based endpoints will be 
assessed by BICR and OS assessment is an objective. Therefore, an open-label design is not 
expected to introduce bias in this trial. 
5.5 
Justification for Dose 
5.5.1 
Justification for Dosing Regimen of Nivolumab 
Nivolumab monotherapy was originally approved as a body-weight based dose of 3 mg/kg Q2W, 
and was updated to 240 mg Q2W or 480 mg Q4W in multiple indications.42,43 Nivolumab 360 mg 
Q3W is also under evaluation in monotherapy and in combination therapy studies. Less frequent 
360 mg Q3W and 480 mg Q4W dosing regimens can reduce the burden to patients of frequent, 
lengthy IV treatments and allow combination of nivolumab with other agents using alternative 
dosing regimens. 
The benefit-risk profiles of nivolumab 240 mg Q2W, 360 mg Q3W, and 480 mg Q4W are 
predicted to be comparable to 3 mg/kg Q2W. This assessment is based on a comprehensive 

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characterization of nivolumab PK, safety, efficacy, and exposure-response relationships across 
indications. Population PK (PPK) analyses have shown that the PK of nivolumab is linear with 
proportional exposures over a dose range of 0.1 to 10 mg/kg; no clinically meaningful differences 
in PK across ethnicities and tumor types were observed. Using the PPK model, the exposures 
following administration of several dosing regimens of nivolumab administered as a flat dose were 
simulated, including 240 mg Q2W, 360 mg Q3W, and 480 mg Q4W. The simulated average serum 
concentration at steady state following administration of nivolumab 360 mg Q3W and 480 mg 
Q4W are predicted to be similar to those following administration of nivolumab 240 mg Q2W and 
nivolumab 3 mg/kg Q2W administered to patients over a wide body weight range (34-180 kg) 
across tumor types. 
Extensive exposure-response (E-R) analyses of multiple PK measures (maximum serum 
concentration at Day 1, average serum concentration at Day 28 [Cavg28], and trough serum 
concentration at Day 28) and efficacy and safety endpoints indicated that the efficacy of the 
flat-dose 480 mg IV regimen are similar to that of 3 mg/kg Q2W IV regimen. In E-R efficacy 
analyses for OS and ORR conducted in melanoma, RCC, and NSCLC using Cavg28 as the 
exposure measure, probabilities of achieving a response and survival probabilities at 1 year and 
2 years for IV 480 mg Q4W were similar to that of IV 3 mg/kg Q2W. In E-R safety analyses, it 
was demonstrated that the exposure margins for safety are maintained following nivolumab 480 
mg Q4W, and the predicted risks of discontinuations due to AEs or death, AE Grade ≥ 3, and 
immune-mediated AEs (IMAEs) Grade ≥ 2 are similar following nivolumab 480 mg Q4W relative 
to nivolumab 3 mg/kg Q2W across tumor types. In addition, nivolumab exposures with 240 mg 
Q2W, 360 mg Q3W, and 480 mg Q4W flat-dose IV regimens across tumor types are maintained 
well below the corresponding exposures observed with the well-tolerated 10 mg/kg IV nivolumab 
Q2W dose regimen. 
5.5.2 
Justification for Dosing Regimen of Nivolumab plus Ipilimumab 
The phase 2 CA209568 study had a safety lead-in phase which evaluated the safe dosing level of 
nivolumab and ipilimumab plus platinum-based doublet chemotherapy, which is applied in the 
CA2099LA treatment arm. In CA209568, participants received nivolumab 360 mg every 3 weeks 
and ipilimumab 1 mg/kg every 6 weeks combined with 2 cycles of platinum-based chemotherapy, 
followed by nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks until 
progression or unacceptable toxicity. 
The safety lead-in phase of CA209568 treated 36 participants with a minimum follow-up of 
11 weeks (longest follow-up of 9 months, median follow-up of 4.7 months). There was 1 case of 
dose limiting toxicities (DLTs) as defined by hepatic enzyme elevation. No safety concerns were 
observed with ongoing monitoring (DBL: July, 2018). In August 2017, the independent DMC 
recommended to initiate CA2099LA based of the evaluation of safety data from study CA209568, 
where the same dosing regimen was investigated. 
Moreover, and in addition to the regular monitoring of the CA2099LA study, the independent 
DMC had an early review of the safety data after 15 patients were treated with nivolumab and 
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up. As planned in the CA2099LA DMC Charter, the independent DMC reviewed the safety data 
during the first safety review meeting in May 2018 and recommended the study to continue with 
no modification. As of March 2019, 361 patients were randomized in the nivolumab plus 
ipilimumab treatment arm (with 2 cycles of histology-based platinum doublet chemotherapy) in 
the CA2099LA study. 
In CA209568 and CA2099LA trials, nivolumab 360 mg every 3 weeks plus ipilimumab 1 mg/kg 
every 6 weeks combined with 2 cycles of platinum-based chemotherapy, which was followed by 
nivolumab 360 mg every 3 weeks and ipilimumab 1 mg/kg every 6 weeks, has been tolerated. 
Therefore, the CA20973L study using this same IO combination (nivolumab 360 mg Q3W + 
ipilimumab 1 mg/kg Q6W) without chemotherapy should have a less toxic profile and thus should 
be tolerated. Additionally, safety will be regularly monitored by independent DMC review 
throughout the CA20973L trial. 
6 
STUDY POPULATION 
For entry into the study, the following criteria MUST be met. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, are not permitted. 
6.1 
Inclusion Criteria 
6.1.1 
Inclusion Criteria for CCRT 
1) Signed Written Informed Consent 
a) Participants or legally acceptable representatives (LAR, see Appendix 2) (where acceptable 
per local guidelines) must have signed and dated an IRB/IEC approved written informed 
consent form in accordance with regulatory and institutional guidelines. This must be 
obtained before the performance of any protocol related procedures that are not part of 
normal participant care 
b) Participants must be willing and able to comply with scheduled visits, treatment schedule, 
and laboratory testing 
2) Participant and Target Disease Characteristics 
a) Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (See Appendix 5) 
b) Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) 
pathologically confirmed (including cytology) NSCLC, according to 8th TNM 
classification,44 that is amenable to definitive CCRT. Participants who are not planned for 
potential curative surgical resection are eligible, except for those foregoing surgery due to 
clinical contraindication for general anesthesia/surgery. Participants must be evaluated by 
the site’s multidisciplinary team (eg, medical oncologist, surgeon, radiologist) during 
screening to assess the suitability of the participant for the study. 
i) Overt cT4 disease. Vertebral invasive disease must not extend into the spinal canal. OR 
ii) Nodal status N2 or N3 must be proven (by biopsy in at least one N2 or N3 node, via 
EBUS, mediastinoscopy, or thoracoscopy) OR 

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iii) Nodal status N1 must be proven by biopsy in at least one N1 node via EBUS, 
mediastinoscopy, or thoracoscopy for T3 disease, unless lesion unamenable or 
medically infeasible (must be documented in medical record). 
Note: fine needle aspiration/cytology is acceptable for diagnosis and staging purposes. 
c) Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy 
given as primary therapy for locally advanced disease 
d) Measurable disease per RECIST 1.1 criteria 
e) All participants must have tissue submitted to a central laboratory during screening. Either 
a formalin-fixed, paraffin-embedded (FFPE) tissue block or 5 to 10 unstained tumor tissue 
sections, obtained within 3 months prior to enrollment, with an associated pathology report, 
must be submitted to the central laboratory for inclusion. Biopsy should be excisional, core 
needle or surgical specimen. Fine needle aspiration is unacceptable for submission. The 
central laboratory must provide IRT with PD-L1 status prior to randomization. PD-L1 
testing will be performed using the validated Agilent/Dako PD-L1 IHC 28-8 pharmDx 
assay. 
3) Age and Reproductive Status 
a) Males and females, ≥ 18 years of age 
b) Women of childbearing potential (WOCBP) must have a negative serum or urine 
pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) at screening and 
within 24 hours prior to the start of study treatment. 
i) If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum 
pregnancy test is required. In such cases, the participant must be excluded from 
participation if the serum pregnancy result is positive. 
ii) Additional requirements for pregnancy testing during and after study intervention are 
located in Section 2, Schedule of Activities 
iii) The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy 
c) Women must not be breastfeeding 
d) Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) 
of contraception for the duration of treatment with study treatment and for 5 months post- 
treatment completion, or according to approved local Product label requirements for 
individual chemotherapy agents, whichever is longer. Women should use an adequate 
method(s) of contraception as indicated in Appendix 4 
i) A female participant is eligible to participate if she is not pregnant or breastfeeding, 
and at least 1 of the following conditions applies: 
(1) Is not a WOCBP with documented proof that they are not of childbearing potential 
OR 

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(2) Is a WOCBP and using a contraceptive method that is highly effective (with a 
failure rate of < 1% per year), with low user dependency, as described in Appendix 
4 during the intervention period and for at least 5 months post-treatment 
completion, or according to approved local product label requirements for 
individual chemotherapy agents, whichever is longer, and agrees not to donate eggs 
(ova, oocytes) for the purpose of reproduction for the same time period 
Note: Women who are not of childbearing potential are exempt from contraceptive 
requirements 
e) Males who are sexually active with WOCBP must agree to follow instructions for method(s) 
of contraception (Appendix 4) for the duration of treatment with study treatment(s) and 7 
months post-treatment completion, or according to approved local Product label 
requirements for individual chemotherapy agents, whichever is longer. In addition, male 
participants must be willing to refrain from sperm donation during this time. 
f) Investigators shall counsel WOCBP, and male participants who are sexually active with 
WOCBP, on the importance of pregnancy prevention, the implications of an unexpected 
pregnancy, and the potential of fetal toxicity occurring due to transmission of study 
treatment to a developing fetus. 
i) The investigator shall evaluate the effectiveness of the contraceptive method in 
relationship to the first dose of study intervention. 
ii) Local laws and regulations may require the use of alternative and/or additional 
contraception methods. 
 
6.1.2 
Inclusion Criteria for Maintenance Treatment 
4) For entry into maintenance therapy, the following criteria MUST be met: 
a) Note: Inclusion criteria 4 a) was removed as per Protocol Amendment 02. Eastern 
Cooperative Oncology Group (ECOG) performance status ≤ 1 (Appendix 5) 
b) No BICR-confirmed progressive disease per RECIST 1.1 during or after CCRT 
c) No current or prior use of immunosuppressive medication within 14 days before the first 
dose of maintenance immunotherapy, with the exceptions of intranasal and inhaled 
corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 
10 mg/day of daily prednisone equivalent. Systemic steroid administration required as 
prophylaxis against or to manage toxicities arising from CCRT is allowed 
d) Any toxicity from CCRT should resolve to Grade 1 or baseline (except for Grade 2 fatigue, 
esophagitis, or alopecia). Participants with irreversible, well controlled, or recovering from 
toxicity that is not reasonably expected to be exacerbated by study treatment may be 
included after consultation with the BMS medical monitor. Participants with 
myelosuppression may be allowed to proceed with maintenance therapy at the 
investigator’s discretion 
e) Participants in Arm A and Arm B that received nivolumab should NOT meet 
discontinuation criteria for immunotherapy (Section 8.1.1) 

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6.2 
Exclusion Criteria 
6.2.1 
Exclusion Criteria for CCRT 
1) Medical Conditions 
a) Any condition including medical, emotional, psychiatric, or logistical that, in the opinion 
of the Investigator, would preclude the participant from adhering to the protocol or would 
increase the risk associated with study participation or study treatment administration or 
interfere with the interpretation of safety results (eg, a condition associated with diarrhea 
or acute diverticulitis) 
b) Active infection requiring systemic therapy within 14 days prior to randomization 
c) Concurrent malignancy (present during screening) requiring treatment or history of prior 
malignancy active within 2 years prior to randomization (ie, participants with a history of 
prior malignancy are eligible if treatment was completed at least 2 years before 
randomization and the participant has no evidence of disease). Participants with history of 
prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that 
have undergone definitive treatment at any time are also eligible 
d) Participants with an active, known, or suspected autoimmune disease. Participants with 
type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin 
disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or 
conditions not expected to recur in the absence of an external trigger are permitted to enroll 
e) Participants with a condition requiring systemic treatment with either corticosteroids 
(> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 
days of start of randomization. Inhaled or topical steroids, and adrenal replacement steroid 
doses > 10 mg daily prednisone equivalent, are permitted in the absence of active 
autoimmune disease 
f) Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or 
any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint 
pathways 
g) Presence of pleural/pericardial effusion on CT scan and/or X-ray, unless it is not 
cytologically positive nor exudative via pleuracentesis. Effusions that are too small to be 
tapped safely are acceptable 
h) Participants with EGFR mutation regardless of mutation type are excluded. Non-squamous 
tumor with unknown EGFR mutation status must be tested for EGFR mutation (PCR-based 
test should be used). 
i) Known ALK translocation and/or ROS1 rearrangement 
j) Note: Exclusion criteria 1 j) was removed as per revised protocol 01: Clinical evidence 
of hearing loss 
k) Note: Exclusion criteria 1 k) was removed as per revised protocol 01: ≥ Grade 2 
peripheral neuropathy 
l) History of organ or tissue transplant that requires systemic use of immune suppressive 
agents 
m) Known history of positive test for human immunodeficiency virus (HIV) or known 
acquired immunodeficiency syndrome (AIDS). Note: Testing for HIV must be performed 
at sites where mandated locally. 

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n) Previous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 
4 weeks prior to screening. Symptoms must have resolved and based on investigator 
assessment in consultation with the medical monitor, there are no sequelae that would place 
the participant at a higher risk of receiving investigational treatment (see Section 6.4.1). 
2) Prior/Concomitant Therapy 
a) Prior thoracic radiotherapy. Exceptions are prior radiotherapies involving the chest for 
clinical conditions other than lung cancers (eg, breast cancer) of which the radiation field 
does not overlap with that of the disease under study AND does not have FDG uptake at 
the previously irradiated area of the lung per the PET scan performed during screening. All 
other prior radiotherapy is allowed and must be completed at least 30 days prior to study 
treatment with residual toxicities resolved prior to study enrollment. 
b) Use of an investigational agent or an investigational device within 28 days before 
administration of first dose of study treatment. 
c) Participants who have received a live / attenuated vaccine within 30 days before first 
treatment. 
d) Treatment with complementary medications (eg, herbal supplements or traditional Chinese 
medicines) intended for general health support or to treat the disease under study within 
2 weeks prior to randomization/treatment. See Section 7.7.1 for prohibited therapies. 
e) Pancoast tumor or other situations with surgery as part of management plan. 
f) Radiation plan is not likely to comply with lung V20 <35% (ideally <30%) 
i) Note: Exclusion criteria 2 f) i was removed as per revised protocol 01: Mean lung 
dose <20 Gy and/or V20<35%, AND V5≤60% 
ii) Note: Exclusion criteria 2 f) ii was removed as per revised protocol 01: Mean 
esophagus dose <34Gy 
iii) Note: Exclusion criteria 2 f) iii was removed as per revised protocol 01: Mean heart 
dose <15Gy 
g) Participants currently in other interventional trials, including those for COVID-19, may not 
participate in BMS clinical trials until the protocol-specific washout period is achieved. If 
a study participant has received an investigational COVID-19 vaccine or other 
investigational product designed to treat or prevent COVID-19 prior to screening, 
enrollment must be delayed until the biologic impact of the vaccine or investigational 
product is stabilized, as determined by discussion between the investigator and the medical 
monitor. 
3) Physical and Laboratory Test Findings 
a) WBC < 2000/μL 
b) Neutrophils < 1500/μL 
c) Platelets < 100 x 103/μL 
d) Hemoglobin < 9.0 g/dL 
 
Note: May not transfuse within 14 days of randomization to meet eligibility criteria 3)a, 3)b, 3)c, 
and 3)d. 

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e) Serum creatinine > 1.5 x ULN, unless creatinine clearance ≥ 40 mL/min (measured or 
calculated using the Cockcroft-Gault formula) for participants receiving carboplatin and 
≥60 mL/min for participants receiving cisplatin 
Female CrCl = (140- age in years) x weight in kg x 0.85 
72 x serum creatinine in mg/dL 
Male CrCl = (140- age in years) x weight in kg x 1.00 
72 x serum creatinine in mg/dL 
f) AST/ALT > 3.0 x ULN 
g) Total bilirubin > 1.5 x ULN (except participants with Gilbert Syndrome who must have a 
total bilirubin level of < 3.0 x ULN) 
h) Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, 
eg, Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C 
antibody (anti-HCV) positive (except if HCV-RNA negative) 
i) Inadequate pulmonary function defined as forced expiratory volume in 1 second (FEV1) 
≤ 50% of predicted normal volume and/or carbon monoxide lung diffusing capacity 
(DLCO) ≤ 40% of predicted normal value 
4) Allergies and Adverse Drug Reaction 
a) History of allergy or hypersensitivity to study treatment components 
b) History of severe hypersensitivity reaction to any monoclonal antibody 
5) Other Exclusion Criteria 
a) Prisoners or participants who are involuntarily incarcerated. (Note: Under certain specific 
circumstances a person who has been imprisoned may be included or permitted to continue 
as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required.) 
b) Participants who are compulsorily detained for treatment of either a psychiatric or physical 
(eg, infectious disease) illness. 
Note: The approved local Product Label requirements for the individual chemotherapy drugs in 
this trial must also be followed when determining participant eligibility. 
6.2.2 
Exclusion Criteria for Maintenance 
1) For entry into maintenance therapy, any of the following criteria MUST NOT be met: 
a) Any condition including medical, emotional, psychiatric, or logistical that, in the opinion 
of the Investigator, would preclude the participant from adhering to the protocol or would 
increase the risk associated with study participation or study treatment administration or 
interfere with the interpretation of safety results 
2) Physical and Laboratory Test Findings 
a) Criteria 7 a) was removed from revised protocol 01: WBC < 2000/μL 
b) Criteria 7 b) was removed from revised protocol 01: Neutrophils < 1500/μL 
c) Criteria 7 c) was removed from revised protocol 01: Platelets < 100 x 103/μL 
d) Criteria 7 d) was removed from revised protocol 01: Hemoglobin < 9.0 g/dL 

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e) Serum creatinine > 1.5 x ULN, unless creatinine clearance ≥ 40 mL/min (measured or 
calculated using the Cockcroft-Gault formula) 
Female CLcr = ([140 - age in years] x weight in kg x 0.85) 
72 x serum creatinine in mg/dL 
Male CLcr = ([140 - age in years] x weight in kg x 1.00) 
72 x serum creatinine in mg/dL 
f) AST/ALT > 3.0 x ULN 
g) Total bilirubin > 1.5 x ULN (except participants with Gilbert Syndrome who must have a 
total bilirubin level of < 3.0 x ULN) 
If a delay of > 6 weeks is needed in the recovery period, approval by medical monitor or designee 
is required to move on to the maintenance period, and this must be documented in the participant’s 
medical record. 
Eligibility criteria for this study have been carefully considered to ensure the safety of the study 
participants and that the results of the study can be used. It is imperative that participants fully 
meet all eligibility criteria. 
6.3 
Lifestyle Restrictions 
During the CCRT Period, esophageal complaints are common with combined modality therapy. 
Esophagitis does not constitute a reason to interrupt or delay radiotherapy or chemotherapy 
provided oral intake is sufficient to maintain hydration. Participants should be advised to avoid 
alcoholic, acidic, or spicy foods or beverages. 
6.4 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but who 
are not subsequently randomized in the study/included in the analysis population. A minimal set 
of screen failure information is required to ensure transparent reporting of screen failure 
participants, to meet the Consolidated Standards of Reporting Trials (CONSORT) publishing 
requirements, as applicable, and to respond to queries from regulatory authorities. Minimal 
information includes date of consent, demography, screen failure details, eligibility criteria, and 
any serious AEs. 
6.4.1 
Retesting During Screening Period 
Participant Re-enrollment: This study permits the re-enrollment of a participant that has 
discontinued the study as a pre-treatment failure (ie, participant has not been randomized / has not 
been treated). If re-enrolled, the participant must be re-consented and assigned a new participant 
number from IRT. 
Retesting of laboratory parameters and/or other assessments within any single Screening Period 
will be permitted (in addition to any parameters that require a confirmatory value). 
The most current result prior to Randomization is the value by which study inclusion will be 
assessed, as it represents the participant’s most current clinical state. 

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Laboratory parameters and/or assessments that are included in Table 2-1 Screening Procedural 
Outline may be repeated in an effort to find all possible well-qualified participants. Consultation 
with the Medical Monitor may be needed to identify whether repeat testing of any particular 
parameter is clinically relevant. 
Testing for asymptomatic SARS-CoV-2 infection, for example by reverse transcription (RT)-PCR 
or viral antigen is not required. However, some participants may develop suspected or confirmed 
symptomatic SARS-CoV-2 infection or be discovered to have asymptomatic SARS-CoV-2 
infection during the screening period. In such cases, participants may be considered eligible for 
the study after meeting all inclusion/exclusion criteria related to active infection, and after meeting 
the following criteria: 
• At least 10 days (20 days for severe/critical illness) have passed since symptoms first appeared 
or positive RT-PCR or viral antigen test result, and 
• At least 24 hours have passed since last fever without the use of fever-reducing medications, 
and 
• Acute symptoms (eg, cough, shortness of breath) have resolved and 
• In the opinion of the investigator, there are no COVID-19-related sequelae that may place the 
participant at a higher risk of receiving investigational treatment, and 
• Negative follow-up SARS-CoV-2 RT-PCR or viral antigen test based on institutional, local, 
or regional guidelines 
 
7 
TREATMENT 
Study treatment is defined as any investigational treatment(s), marketed product(s), placebo or 
medical device intended to be administered to a study participant according to the study 
randomization or treatment allocation. 
Study  treatment  includes  both  Investigational  [Medicinal]  Product  (IP/IMP)  and 
Non-investigational [Medicinal] Product (Non-IP/Non-IMP) and can consist of the following: 
An investigational product, also known as investigational medicinal product in some regions, is 
defined a pharmaceutical form of an active substance or placebo being tested or used as a reference 
in a clinical study, including products already with a marketing authorization but used or 
assembled (formulated or packaged) differently than the authorized form, or used for an 
unauthorized indication, or when used to gain further information about the authorized form. 

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• Ipilimumab Solution for Injection 
• Nivolumab Solution for Injection 
• Durvalumab Solution for Injection 
• Cisplatin Solution for Infusion 
• Etoposide Concentrate for Solution for Injection 
• Carboplatin Solution for Injection 
• Pemetrexed Powder for Concentrate for Solution for Infusion 
• Paclitaxel Solution for Infusion 
 
Other medications used as support or escape medication for preventative, diagnostic, or therapeutic 
reasons, as components of the standard of care for a given diagnosis, may be considered as 
non-investigational products. Note: Radiotherapy administered in this study is NOT considered 
study treatment. 

 
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Table 7-1: 
Study treatments for CA20973L 
 
Product Description / Class and 
Dosage Form 
Potency 
IP/ 
Non-IP 
Blinded or 
Open Label 
Packaging / 
Appearance 
Storage Conditions 
(per label) 
Ipilimumab 
Solution for Injection 
200 mg 
(5 mg/mL) 
IP 
Open-label 
Vial (one or more 
vials per carton) 
Store at 2 - 8 C. 
Protect from light and freezing. 
Ipilimumab 
Solution for Injectiona 
50 mg 
(5 mg/mL) 
IP 
Open-label 
Vial (one or more 
vials per carton) 
Store at 2 - 8 C. 
Protect from light and freezing. 
Nivolumab Solution for 
Injectionb 
100 mg 
(10 mg/mL) 
IP 
Open-label 
Vial (multiple 
vials/carton) 
Store at 2 - 8 C. 
Protect from light and freezing. 
Cisplatin Solution for Infusionc 
100 mg/vial 
(1 mg/mL) 
IP 
Open-label 
Vial (multiple 
vials/carton) 
Product should be stored as per market 
product conditions 
Etoposide Concentrate for Solution for 
Injectionc 
100 mg/vial 
(20 mg/mL) 
IP 
Open-label 
Vial (multiple 
vials/carton) 
Product should be stored as per market 
product conditions 
Durvalumab Solution for Injectionc 
500 mg/vial 
(50 mg/mL) 
IP 
Open-label 
Vial (multiple 
vials/carton) 
Product should be stored as per market 
product conditions 
Carboplatin Solution for Injectionc 
450 mg/vial 
(10 mg/mL) 
IP 
Open-label 
Vial (multiple 
vials/carton) 
Product should be stored as per market 
product conditions 
Pemetrexed Powder for Concentrate for 
Solution for Infusionc 
500 mg/vial 
IP 
Open-label 
Vial (one or more 
vials per carton) 
Product should be stored as per market 
product conditions 
Paclitaxel Solution for Infusionc 
100 mg/vial 
(6 mg/mL) 
IP 
Open-label 
Vial (one or more 
vials per carton) 
Product should be stored as per market 
product conditions 
Abbreviations: IP, investigational product; SmPC, Summary of Product Characteristics. 
a 50 mg ipilimumab vial will be available starting Q3 2022 and may be used in this study. 
b May be labeled as either “BMS-936558-01” or “Nivolumab”. 
c These products may be obtained by the investigational sites as local commercial product in certain countries if allowed by local regulations. In these cases, 
products may be a different pack size/potency than listed in the table. The approved local product label (including package insert, SmPC, or equivalent), or local 
standards for preparing and administering these agents may be used, as long as there is no change in the treatment dose or administrative schedule, as specified 
in the protocol. 
 
 
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7.1 
Treatments Administered 
Table 7.1-1: 
Selection and Timing of Dose 
 
Study 
Treatmenta 
Unit Dosage level(s) 
Dosage formulation 
Frequency of Administration 
Route of 
Administration 
Nivolumab 
• 
360 mg (Arms A and B) 
• 
480 mg (Arm B only) 
• 
Q3W (in CCRT Period for Arms A and 
B; in Maintenance Period for Arm A) 
• 
Q4W (in Maintenance Period for Arm B) 
IV 
Cisplatinb 
(+ etoposide) 
80 mg/m2 
D1 Q3W for up to 3 cycles in CCRT Period 
IV 
Etoposidec 
100 mg/m2 
D1 to D3 Q3W for up to 3 cycles in CCRT 
Period 
IV 
Cisplatinb 
(+ pemetrexed) 
75 mg/m2 
D1 Q3W for up to 3 cycles in CCRT Period 
IV 
Pemetrexedc 
500 mg/m2 
D1 Q3W for up to 3 cycles in CCRT Period 
IV 
Carboplatin 
(+ etoposide or 
pemetrexed) 
AUC 5 
D1 Q3W for up to 3 cycles in CCRT Period 
IV 
Carboplatin 
(+ paclitaxel) 
a) AUC 5 or 6 
b) AUC 2 
a) D1 Cycle 1 for 1 cycle in CCRT Period 
b) D1, D8, D15 for Cycle 2 and Cycle 3 in 
CCRT Period 
IV 
Paclitaxel 
a) 175 or 200 mg/m2 
b) 45 or 50 mg/m2 
a) D1 Cycle 1 for 1 cycle in CCRT Period 
b) D1, D8, D15 for Cycle 2 and Cycle 3 in 
CCRT Period 
IV 
Ipilimumab 
1 mg/kg 
Q6W (maintenance in Arm A) 
IV 
Durvalumab 
10 mg/kg 
Q2W (Maintenance in Arm C) 
IV 
Abbreviations: AUC, area under the concentration-time curve; CCRT, concurrent chemoradiotherapy; D, day; 
IV, intravenous; Q2W, every 2 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks; Q6W, every 6 weeks. 
a If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 of the CCRT 
period (Arms A, B, or C), the investigator has the option to skip Cycle 1 of systemic anticancer therapy alone, and 
initiate treatment with radiotherapy concurrently with systemic anticancer therapy (Cycle 2). All study procedures 
for Cycle 2 and Cycle 3 during the CCRT period are still to be followed. An additional cycle of consolidation 
systemic anticancer therapy will not be administered after the completion of radiotherapy in this situation. 
b If cisplatin cannot be used, it can be replaced by carboplatin. 
c If pemetrexed cannot be used, it can be replaced by etoposide. 
 
Study agent(s) should be administered in an area with access to resuscitation equipment. All 
participants should begin study treatment within 7 calendar days of randomization. Information on 
drug preparation, infusion techniques, and materials required for the infusions are described in 
Pharmacy Manual. 

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7.1.1 
Nivolumab Dosing 
In Arm A and Arm B during CCRT Period, participants should receive nivolumab at a dose of 
360 mg over an approximately 30 (± 5) minute IV infusion on Day 1 of each treatment cycle up to 
3 cycles and prior to the administration of chemotherapy. If needed, flush the IV line with an 
appropriate amount of diluent (eg, 0.9% Sodium Chloride or 5% Dextrose in water) to ensure that 
the complete dose is administered over approximately 30 minutes. Participants may be dosed Q3W 
± 3 days. See Section 7.4.5 for timing of chemotherapy dosing in case of dose delay of nivolumab. 
Participants may be dosed no less than 18 days from the previous dose of nivolumab during Q3W 
cycles. See Section 7.1.5 for option to skip cycle 1 of nivolumab + chemotherapy alone if RT 
planning is completed prior to the first dose at Cycle 1. 
In Arm A Maintenance Period, participants should receive nivolumab at a dose of 360 mg over an 
approximately 30 (± 5) minute infusion followed by ipilimumab at a dose of 1 mg/kg over an 
approximately 30 (± 5) minute infusion on Day 1 of every cycle (Q6W cycles). In addition, 
nivolumab will be administered on Day 22 of every cycle, at a dose of 360 mg over an 
approximately 30 (± 5) minute infusion. Treatment will continue until confirmed progression, 
unacceptable toxicity, withdrawal of consent, completion of approximately 12 months of 
treatment, or the study ends, whichever occurs first. Participants may be dosed Q3W ± 3 days for 
nivolumab. When study treatments nivolumab and ipilimumab are to be administered on the same 
day, nivolumab is to be administered first. Nivolumab infusion must be promptly followed by a 
flush of diluent to clear the line of nivolumab before starting the ipilimumab infusion. The second 
infusion will always be the ipilimumab study treatment and will start after the infusion line has 
been flushed, filters changed, and participant has been observed to ensure no infusion reaction has 
occurred. 
There will be no dose escalations or reductions of nivolumab or ipilimumab allowed. Participants 
may be dosed no less than 18 days from the previous dose of nivolumab during Q3W cycles. When 
dose is delayed, see Section 7.4.4 for rules of rescheduling. Premedications are not recommended 
for the first dose of nivolumab. 
In Arm B Maintenance Period, participants should receive nivolumab at a dose of 480 mg over an 
approximately 30 (± 5) minute infusion on Day 1 of each treatment cycle until progression, 
unacceptable toxicity, withdrawal of consent, completion of approximately 12 months of 
treatment, or the study ends, whichever occurs first. If needed, flush the IV line with an appropriate 
amount of diluent (eg, 0.9% Sodium Chloride or 5% Dextrose in water) to ensure that the complete 
dose is administered over approximately 30 minutes. Participants may be dosed Q4W ± 3 days for 
nivolumab. 
There will be no dose escalations or reductions of nivolumab allowed. Participants may be dosed 
no less than 25 days from the previous dose of nivolumab during Q4W cycles. Premedications are 
not recommended for the first dose of nivolumab. 
Participants should be carefully monitored for infusion reactions during nivolumab and/or 
ipilimumab administration. If an acute infusion reaction is noted, participants should be managed 
according to Section 7.4.4.2. 

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Doses of nivolumab and ipilimumab may be interrupted, delayed, or discontinued depending on 
how well the participant tolerates the treatment. 
Please refer to the current IB and/or Pharmacy Manual for further details regarding storage, 
preparation, and administration of nivolumab. 
Care must be taken to assure sterility of the prepared solution as the product does not contain any 
antimicrobial preservative or bacteriostatic agent. 
In Arm A and Arm B, participants may be retreated with nivolumab after completing 12 months 
of treatment during the Maintenance Period, if the participant has achieved disease control (CR, 
PR, or SD) and subsequently progresses. See Section 5.1.6. 
7.1.2 
Ipilimumab Dosing 
In Arm A Maintenance Period, after the infusion of nivolumab, the infusion line should be flushed 
and the filters changed. Participants should then receive ipilimumab 1 mg/kg over an 
approximately 30 (± 5) minute infusion IV every 6 weeks (Q6W) starting on Day 1. Participants 
will be dosed Q3W ± 3 days for nivolumab and Q6W ± 3 days for ipilimumab. Treatment will 
continue until confirmed progression, unacceptable toxicity, withdrawal of consent, completion of 
approximately 12 months of treatment, discontinuation of nivolumab, or the study ends, whichever 
occurs first. 
Ipilimumab dosing calculations should be based on the body weight. Dosing calculations should 
be based on the body weight assessed on C1D1 in Maintenance. It is not necessary to re-calculate 
subsequent doses if the participant weight is within 10% of the baseline weight. All doses should 
be rounded to the nearest milligram. There will be no dose modifications allowed. Participants 
may be dosed no less than 37 days from the previous dose of ipilimumab. 
Ipilimumab is not permitted to continue on study after nivolumab is discontinued. The assessment 
for discontinuation of nivolumab should be made separately from the assessment made for 
discontinuation of ipilimumab. Although there is overlap among the discontinuation criteria, if 
discontinuation criteria are met for ipilimumab but not for nivolumab, treatment with nivolumab 
may continue if ipilimumab is discontinued. 
Participants should be carefully monitored for infusion reactions during ipilimumab 
administration. If an acute infusion reaction is noted, participants should be managed according to 
Section 7.4.4.2. 
Doses of ipilimumab may be interrupted, delayed, or discontinued depending on how well the 
participant tolerates the treatment. Dosing visits are not skipped, only delayed. 
Use separate infusion bags and filters when administering nivolumab and ipilimumab on the same 
day. 
For details regarding ipilimumab storage, preparation, and administration, please refer to the 
current IB and/or Pharmacy Manual. 

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In Arm A, participants may be retreated with nivolumab and ipilimumab after completing 
12 months of treatment during the Maintenance Period, if the participant has achieved disease 
control (CR, PR, or SD) and subsequently progresses. Ipilimumab monotherapy is not permitted. 
See Section 5.1.6. 
7.1.3 
Durvalumab Dosing 
In Arm C Maintenance Period, participants should receive durvalumab at a dose of 10 mg/kg as a 
60 (± 5) minute infusion on Day 1 of each treatment cycle until confirmed progression, 
unacceptable toxicity, withdrawal of consent, completion of approximately 12 months of 
treatment, or the study ends, whichever occurs first. 
There will be no dose escalations or reductions of durvalumab allowed. Participants may be dosed 
Q2W ± 3 days. Premedications are not recommended for the first dose of durvalumab. 
Participants should be carefully monitored for infusion reactions during durvalumab 
administration. If an acute infusion reaction is noted, participants should be managed according to 
the local durvalumab prescribing information. 
Doses of durvalumab may be interrupted, delayed, or discontinued depending on how well the 
participant tolerates the treatment. Dosing visits are not skipped, only delayed. Please refer to the 
approved local Product Label for durvalumab for additional information. 
7.1.4 
Chemotherapy Dosing 
During the CCRT Period, participants will be given chemotherapy for up to 3 cycles, with each 
cycle lasting 3 weeks. See Section 7.1.5 for option to skip cycle 1 of chemotherapy ± nivolumab 
alone if RT planning is completed prior to the first dose of therapy at Cycle 1. While 
etoposide/cisplatin and paclitaxel/carboplatin are applicable to any histology, participants with 
tumor of non-squamous histology have an additional option which is pemetrexed/cisplatin. In the 
case cisplatin cannot be given (eg, poor tolerability), carboplatin can replace cisplatin. The reasons 
must be recorded in the eCRF and medical record. In the case pemetrexed cannot be given 
(eg, poor tolerability), etoposide can replace pemetrexed. The reasons must be recorded in the 
eCRF and medical record. 
7.1.4.1 
Paclitaxel/Carboplatin Dosing 
Each cycle of paclitaxel + carboplatin will last for 3 weeks. Treatment with paclitaxel and 
carboplatin will be administered as follows for Cycle 1, Cycle 2, and Cycle 3: 
• Cycle 1; Day 1: carboplatin AUC 5 or 6 + paclitaxel 175 or 200 mg/m2 
• Cycle 2 and Cycle 3; Day 1, Day 8, and Day 15: carboplatin AUC 2 + paclitaxel 45 or 50 mg/m2 
 
Days 8 and 15 may be interrupted, delayed, or discontinued depending on how well the participant 
tolerates the treatment and per investigator’s discretion. The carboplatin dose must be calculated 
according to Calvert formula. When calculating creatinine clearance (CrCl), the formula of 
Cockcroft-Gault (see below) should be used or per local standard: 

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• Calvert Formula: Dose (in mg) = Target AUC × (GFR + 25) 
• Cockcroft-Gault: CrCl (
mL ) = 
[140-age (years)×actual body weight (kg)] ×{0.85 if female} 
 
min 
72 × serum creatinine (mg) 
dL 
 
Carboplatin doses (AUC 2 or AUC 5 or 6) will be administered IV over approximately 30 minutes 
(or per local standard). 
Paclitaxel doses of 175 or 200 mg/m2 will be administered IV over approximately 180 minutes (or 
per local standard). Paclitaxel doses of 45 or 50 mg/ m2 will be administered IV over approximately 
60 minutes (or per local standard). 
7.1.4.2 
Etoposide/cisplatin 
Each cycle of etoposide + cisplatin will last for 3 weeks. Etoposide 100 mg/m2 IV will be 
administered over approximately 60 minutes (or per local standard) on Day 1, Day 2, and Day 3 
of each cycle. Days 2 and 3 may be interrupted, delayed, or discontinued depending on how well 
the participant tolerates the treatment and per investigator’s discretion. Cisplatin will be 
administered at a dose of 80 mg/m2 IV on Day 1 of each cycle. Recommended infusion time is 
approximately 60 minutes (or per local standard). 
7.1.4.3 
Pemetrexed/cisplatin 
Each cycle of pemetrexed + cisplatin will last for 3 weeks. Participants will receive pemetrexed at 
a dose of 500 mg/m2 as a 10-minute IV infusion (or per local standard) on Day 1 with cisplatin at 
a dose of 75 mg/m2 as a 60-minute (or per local standard) IV infusion on Day 1 of each cycle. 
Pemetrexed should be infused before cisplatin on Day 1 of a cycle. 
Pre-medications for use with pemetrexed are as follows: 
• Oral corticosteroid should be given according to local standards at a dose equivalent to 
dexamethasone 4 mg BID on the day prior to, the day of, and the day after the administration 
of pemetrexed. 
• Daily oral folic acid 350 mcg to 1000 mcg should be given starting 1 week prior to the first 
dose of pemetrexed, with at least 5 doses of folic acid administered in the 7 days prior to the 
first dose. Oral folic acid should be continued daily throughout the treatment with pemetrexed 
and for 21 days after the last dose of pemetrexed. 
• Intramuscular (IM) injection of vitamin B12 1000 mcg should be given approximately one 
week prior to the first dose of pemetrexed. 
• Participants with non-squamous histology may begin folic acid and vitamin B12 prior to 
randomization in anticipation of administration of pemetrexed 
• Antiemetic premedication may be given per local standard. 
 
7.1.4.4 
Carboplatin Dosing (with Etoposide or Pemetrexed) 
In the event that carboplatin is administered instead of cisplatin with etoposide or pemetrexed, the 
reasons are to be documented in CRF as well as in medical record. Carboplatin at AUC 5 will be 

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given as a 30-minute (or per local standard) IV infusion on Day 1 of each 3 week cycle during 
CCRT. Carboplatin dose must be calculated according to Calvert formula. When calculating 
creatinine clearance (CrCl), the formula of Cockcroft-Gault should be used or per local standard. 
7.1.4.5 
Premedication 
Antiemetic premedication will be administered according to local standards. Recommended 
antiemetic treatments are dexamethasone (dosing according to local standards; an equivalent dose 
of another corticosteroid may be substituted) and a 5-HT3 receptor antagonist (type per 
investigator discretion and local standards-of-care). Additional use of antiemetic premedications 
may be employed at the discretion of the Investigator. Doses of chemotherapy may be interrupted, 
delayed, reduced, or discontinued depending on how well the participant tolerates the treatment. 
See the following sections for more details: Section 7.4 (dose delays) and Section 8 (dose 
discontinuations). 
Pre- and post-hydration for cisplatin should be administered per institutional protocol or per the 
following recommendation: Pre-treatment hydration of 1 to 2 liters of fluid infused IV prior to 
cisplatin infusion; Adequate hydration and urinary output must be maintained for at least 24 hours 
following cisplatin administration. Use of mannitol following the cisplatin infusion is allowed per 
local standard. 
7.1.5 
Radiotherapy Planning and Delivery 
Each participant will receive thoracic radiotherapy in form of IMRT, VMAT, or 3DRT. Irradiation 
commences on D1 of Cycle 2 of systemic anticancer therapy (chemotherapy ± nivolumab) and 
will be delivered 5 days per week in once daily fraction, 2 Gy per fraction, to a target dose of 60-66 
Gy in 30-33 fractions. 
If radiotherapy planning is complete prior to the initiation of systemic anticancer therapy at Cycle 1 
of the CCRT period (Arms A, B, or C), the investigator has the option to skip Cycle 1 of systemic 
anticancer therapy alone, and initiate treatment with radiotherapy concurrently with systemic 
anticancer therapy (Cycle 2). All study procedures for Cycle 2 and Cycle 3 during the CCRT period 
are still to be followed. An additional cycle of consolidation systemic anticancer therapy will not 
be administered after the completion of radiotherapy in this situation. 
If the administration of systemic anticancer therapy at Cycle 2 must be delayed due to toxicity (for 
participants who start systemic treatment at Cycle 1), radiotherapy should start ± 3 days of start of 
systemic anticancer therapy in Cycle 2. It will not be considered a protocol deviation if 
chemoradiation is delayed for administrative reasons (eg, holidays), provided the full planned dose 
of radiotherapy is delivered. More detailed radiotherapy requirements can be found in the Thoracic 
Radiotherapy Guidelines, and QA & QC processes are subject to the CA20973L Radiotherapy 
Manual. 
7.2 
Method of Treatment Assignment 
Before the study is initiated, each user will receive log-in information and directions on how to 
access the IRT. Each participant will be assigned a unique participant number after signing the 
ICF. Participant numbers will be used on all participants’ study information. Participant numbers 

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will not be reassigned. An IRT will be employed to manage participant randomization. The 
investigator or designee will register the participant for enrollment by following the enrollment 
procedures established by BMS. The following information is required for enrollment: 
• Date that informed consent was obtained 
• Year of birth 
• Gender at birth 
 
Once enrolled in IRT, enrolled participants who have met all eligibility criteria will be ready to be 
randomized through the IRT. Refer to the IRT manual for the information required for participant 
randomization. Please note that prior to randomization, the planned chemotherapy regimen, the 
planned number of cycles of chemotherapy (up to 2 cycles or up to 3 cycles), the planned dose 
level of chemotherapy at the start of treatment for agents with more than 1 possible dose level per 
protocol (eg, carboplatin, paclitaxel), and the radiation modality must be pre-defined and 
documented in the IRT and medical records by the investigator. Please note that if the actual 
treatment regimen administered to the participant during the CCRT Period changes from the 
planned regimen documented in the IRT prior to randomization, the rationale for the change must 
be recorded in the CRF and documented in the medical record. 
Participants meeting all eligibility criteria will be randomized in a 1:1:1 ratio to 3 treatment arms 
and stratified by age, PD-L1 status, and stage (per AJCC staging system, 8th edition) as described 
below: 
• Age: 
− <65 years old at time of randomization 
− ≥65 years old at time of randomization 
• Tumor PD-L1 status (from IRT): 
− ≥1% 
− <1% 
− Indeterminate or not evaluable 
• Stage (per AJCC 8th edition): 
− Stage IIIA 
− Stage IIIB 
− Stage IIIC 
 
The randomization procedures will be carried out via permuted blocks within each stratum, defined 
by combination of age, PD-L1 status, and AJCC Stage at Screening. The exact procedures for 
using the IRT will be detailed in the IRT manual. 
7.3 
Blinding 
This is a randomized, open-label study. Blinding procedures are not applicable. 

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7.4 
Dosage Modification 
Dose reductions or dose escalations of nivolumab, ipilimumab, or durvalumab are not permitted 
in this study. Dose modifications for chemotherapy are allowed (see Section 7.4.5). 
Dose Delay Criteria 
• SARS-CoV-2 infection either confirmed or suspected. 
 
Criteria to Resume Treatment 
Participants with SARS-CoV-2 infection (either confirmed or suspected) may resume treatment 
after all of the following: 
• at least 10 days (20 days for severe/critical illness) have passed since symptoms first appeared 
or positive test result (eg, RT-PCR or viral antigen), 
• resolution of acute symptoms (including at least 24 hours has passed since last fever without 
fever reducing medications), 
• evaluation by the Investigator with confirmation that there are no sequelae that would place 
the participant at a higher risk of receiving investigational treatment, and 
• consultation by the medical monitor. 
 
For suspected cases, treatment may also resume if SARS-CoV-2 infection is ruled-out and other 
criteria to resume treatment are met. 
7.4.1 
Nivolumab Dose Delay Criteria 
Nivolumab administration should be delayed for the following: 
• Grade 2 non-skin, drug-related AE, with the exception of fatigue 
• Grade 2 drug-related creatinine, AST, ALT, and/or total bilirubin abnormalities 
• Grade 3 skin, drug-related AE 
• Grade 3 drug-related laboratory abnormality, with the following exceptions: 
− Grade 3 lymphopenia or asymptomatic amylase or lipase does not require dose delay 
− Grade ≥ 3 AST, ALT, total bilirubin will require dose discontinuation 
• Any adverse event, laboratory abnormality, or intercurrent illness which, in the judgment of 
the investigator, warrants delaying the dose of nivolumab. 
 
Participants who require delay of nivolumab should be re-evaluated weekly or more frequently if 
clinically indicated and resume nivolumab dosing when retreatment criteria are met. 
7.4.1.1 
Criteria to Resume Nivolumab 
Participants may resume treatment with nivolumab when the drug-related AE(s) resolve to 
Grade ≤ 1 or baseline value, with the following exceptions: 
• Participants may resume treatment in the presence of Grade 2 fatigue 
• Participants who have not experienced a Grade 3 drug-related skin AE may resume treatment 
in the presence of Grade 2 skin toxicity 

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• For participants with Grade 2 AST, ALT and/or total bilirubin abnormalities, dosing may 
resume when laboratory values return to baseline and management with corticosteroids, if 
needed, is complete. 
• Drug-related pulmonary toxicity, diarrhea or colitis must have resolved to baseline before 
treatment is resumed. Participants with persistent Grade 1 pneumonitis after completion of a 
steroid taper over at least 1 month may be eligible for retreatment if discussed with and 
approved by BMS Medical Monitor (or designee). 
• Participants may resume treatment with study treatment if they have completed AE 
management (ie, corticosteroid taper) or are on ≤ 10 mg prednisone or equivalent. 
 
Participants with drug-related endocrinopathies adequately controlled with only physiologic 
hormone replacement may resume treatment after consultation with the BMS Medical Monitor (or 
designee). Nivolumab therapy must be delayed until such time as this requirement is met. Please 
refer to Section 8.1.1 for special requirements for adrenal insufficiency. 
Protracted delay or discontinuation of nivolumab during the CCRT Period does not prevent 
participants from entering the Maintenance Period in Arm A or Arm B if: 
1) the delay or discontinuation is not due to nivolumab-related toxicities, and 
2) eligibility criteria for initiation of the Maintenance Period are met. 
 
In addition, nivolumab may not be resumed sooner than 18 days after the prior nivolumab dose. 
7.4.2 
Ipilimumab Dose Delay Criteria 
Ipilimumab administration should be delayed as described in dose delay criteria for nivolumab in 
Section 7.4. 
In addition, participants receiving ipilimumab in combination with nivolumab that have drug- 
related toxicities that meet the criteria for dose delay, should have both drugs (ipilimumab and 
nivolumab) delayed until retreatment criteria are met. Exceptions apply to the retreatment criteria 
after dose delay of ipilimumab and nivolumab for Grade ≥ 3 amylase and lipase abnormalities that 
are not associated with symptoms or clinical manifestations of pancreatitis and that are attributed 
to ipilimumab alone. 
Participants who require delay should be re-evaluated weekly or more frequently if clinically 
indicated. Participants should resume dosing when retreatment criteria are met. 
7.4.2.1 
Criteria to Resume Ipilimumab 
Participants may resume treatment with nivolumab and ipilimumab when drug-related AE(s) 
resolve(s) to Grade 1 or baseline value, with the following exceptions: 
• Participants may resume treatment in the presence of Grade 2 fatigue. 
• Participants who have not experienced a Grade 3 drug-related skin AE may resume treatment 
in the presence of Grade 2 skin toxicity. 

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• Participants with baseline Grade 1 AST/ALT or total bilirubin who require dose delays for 
reasons other than a 2-grade shift in AST/ALT or total bilirubin may resume treatment in the 
presence of Grade 2 AST/ALT or total bilirubin. 
• Participants with combined Grade 2 AST/ALT and total bilirubin values meeting 
discontinuation parameters (Section 8.1.2) should have treatment permanently discontinued. 
• Drug-related pulmonary toxicity, diarrhea, or colitis must have resolved to baseline before 
treatment is resumed. 
• Participants who received systemic corticosteroids for management of any drug-related 
toxicity must be off corticosteroids or have tapered down to an equivalent dose of prednisone 
≤ 10 mg/day. 
• Drug-related endocrinopathies adequately controlled with only physiologic hormone 
replacement may resume treatment after consultation with the BMS Medical Monitor. 
Ipilimumab therapy must be delayed until such time as this requirement is met. 
• Dose delay of ipilimumab which results in no ipilimumab dosing for > 12 weeks requires 
ipilimumab discontinuation, with exceptions as noted in Section 8.1.2. 
• Ipilimumab may not be resumed sooner than 37 days after the prior ipilimumab dose. 
• In general, participants who meet criteria to resume ipilimumab will also have met criteria to 
resume nivolumab, so it should be feasible to synchronize dosing of both drugs when resuming 
ipilimumab. In order to facilitate this, the dosing days of nivolumab and ipilimumab may be 
adjusted within the permitted ± 5 day window, as long as consecutive nivolumab doses are 
given at least 18 days apart. 
NOTE: One exception occurs when ipilimumab and nivolumab doses are delayed due to 
drug-related Grade 3 amylase or lipase abnormalities not associated with symptoms or clinical 
manifestations of pancreatitis. If the investigator assesses the Grade 3 amylase or lipase 
abnormality is related to ipilimumab and not related to nivolumab, nivolumab may be resumed 
when the amylase or lipase abnormality resolves to Grade < 3 but ipilimumab may only resume 
when the amylase or lipase abnormality resolves to Grade 1 or baseline. Investigator attribution 
of this toxicity to the ipilimumab dosing must be clearly noted in the participant's medical 
chart. The BMS Medical Monitor should be consulted prior to resuming ipilimumab in the 
participant. 
 
7.4.3 
Dose Delay Criteria for Durvalumab 
Durvalumab-related toxicities should be managed according to the approved Product Label 
requirements for durvalumab. Please refer to the approved durvalumab Product Label for criteria 
to delay, resume, and discontinue durvalumab treatment. 
7.4.4 
Rescheduling Nivolumab and Ipilimumab for Arm A Maintenance 
Period: 
• Ipilimumab should be infused on the same day as nivolumab on Day 1 of every cycle unless 
ipilimumab is delayed. 
• On Day 22 visit of any cycle, if nivolumab dosing is delayed by more than 7 days, the dosing 
on the Day 22 visit within the cycle should be skipped. Dosing with both nivolumab and 

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ipilimumab may resume on D1 of the subsequent cycle as long as the minimum ipilimumab 
dosing interval is 37 days. 
• If an ipilimumab dose is delayed beyond 6 weeks from the prior ipilimumab dose, then 
subsequent ipilimumab doses should be rescheduled with nivolumab as long as the minimum 
dosing interval for 2 consecutive nivolumab dosing is 18 days. 
• A dose delay of ipilimumab which results in no ipilimumab dosing for >12 weeks requires 
ipilimumab discontinuation, with exceptions as noted in Section 8.1. 
 
7.4.4.1 
Management Algorithms for Ipilimumab, Nivolumab, or Durvalumab 
Immuno-oncology agents are associated with AEs that can differ in severity and duration from 
AEs caused by other therapeutic classes. Ipilimumab, nivolumab, and durvalumab are considered 
immuno-oncology agents in this protocol. Early recognition and management of AEs associated 
with immuno-oncology agents may mitigate severe toxicity. Management Algorithms (see 
Appendix 6) and nivolumab and ipilimumab Investigator Brochures have been developed to assist 
investigators in assessing and managing the following groups of AEs: 
• Gastrointestinal 
• Renal 
• Pulmonary 
• Hepatic 
• Endocrinopathy 
• Skin 
• Neurological 
• Myocarditis 
 
Management algorithms for durvalumab may follow the principles aforementioned or per local 
approved Product Label requirements. 
7.4.4.2 
Treatment of Nivolumab or Ipilimumab Infusion Reactions 
Since nivolumab and ipilimumab contain only human immunoglobulin protein sequences, they are 
unlikely to be immunogenic and induce infusion or hypersensitivity reactions. However, if such a 
reaction were to occur, it might manifest with fever, chills, rigors, headache, rash, pruritus, 
arthralgias, hypo- or hypertension, bronchospasm, or other symptoms. All Grade 3 or 4 infusion 
reactions should be reported within 24 hours to the BMS Medical Monitor and reported as an SAE 
if criteria are met. Infusion reactions should be graded according to NCI CTCAE (Version 4.0) 
guidelines. 
Treatment recommendations are provided below and may be modified based on local treatment 
standards and guidelines, as appropriate: 

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For Grade 1 symptoms: (mild reaction; infusion interruption not indicated; intervention not 
indicated) 
• Remain at bedside and monitor participant until recovery from symptoms. The following 
prophylactic premedications are recommended for future infusions: diphenhydramine 50 mg 
(or equivalent) and/or acetaminophen/paracetamol 325 to 1000 mg at least 30 minutes before 
additional nivolumab or ipilimumab administrations. 
 
For Grade 2 symptoms: (moderate reaction requires therapy or infusion interruption but 
responds promptly to symptomatic treatment [eg, antihistamines, non-steroidal 
anti-inflammatory 
drugs, 
narcotics, 
corticosteroids, 
bronchodilators, 
IV 
fluids]; 
prophylactic medications indicated for ≤ 24 hours) 
• Stop the nivolumab or ipilimumab infusion, begin an IV infusion of normal saline, and treat 
the 
participant 
with 
diphenhydramine 
50 
mg 
IV 
(or 
equivalent) 
and/or 
acetaminophen/paracetamol 325 to 1000 mg; remain at bedside and monitor participant until 
resolution of symptoms. Corticosteroid and/or bronchodilator therapy may also be 
administered as appropriate. If the infusion is interrupted, then restart the infusion at 50% of 
the original infusion rate when symptoms resolve; if no further complications ensue after 
30 minutes, the rate may be increased to 100% of the original infusion rate. Monitor participant 
closely. If symptoms recur, then no further nivolumab or ipilimumab will be administered at 
that visit. Administer diphenhydramine 50 mg IV, and remain at bedside and monitor the 
participant until resolution of symptoms. The amount of study treatment infused must be 
recorded on the electronic case report form (eCRF). 
• For future infusions, the following prophylactic premedications are recommended: 
diphenhydramine 50 mg (or equivalent) and/or acetaminophen/paracetamol 325 to 1000 mg 
should be administered at least 30 minutes before nivolumab or ipilimumab infusions. If 
necessary, corticosteroids (up to 25 mg of SoluCortef or equivalent) may be used. 
 
For Grade 3 or 4 symptoms: (severe reaction, Grade 3: prolonged [ie, not rapidly responsive 
to symptomatic medication and/or brief interruption of infusion]; recurrence of symptoms 
following initial improvement; hospitalization indicated for other clinical sequelae [eg, renal 
impairment, pulmonary infiltrates]. Grade 4: Life threatening; pressor or ventilatory 
support indicated) 
• Immediately discontinue infusion of nivolumab or ipilimumab. Begin an IV infusion of normal 
saline and treat the participant as follows: Recommend bronchodilators, epinephrine 0.2 to 
1 mg of a 1:1000 solution for subcutaneous administration or 0.1 to 0.25 mg of a 1:10,000 
solution injected slowly for IV administration, and/or diphenhydramine 50 mg IV with 
methylprednisolone 100 mg IV (or equivalent), as needed. Participant should be monitored 
until the investigator is comfortable that the symptoms will not recur. Nivolumab or 
ipilimumab will be permanently discontinued. Investigators should follow their institutional 
guidelines for the treatment of anaphylaxis. Remain at bedside and monitor participant until 
recovery of the symptoms. 

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In case of late-occurring hypersensitivity symptoms (eg, appearance of a localized or generalized 
pruritus within 1 week after treatment), symptomatic treatment may be given (eg, oral 
antihistamine or corticosteroids). 
7.4.5 
Chemotherapy Dose Delay, Dose Modification, and Criteria to Resume 
Treatment 
Clinical judgment should guide chemotherapy dose modifications in the study and follow local 
institutional standards and approved product labeling. When administering granulocyte colony 
stimulating factors (G-CSF) for supportive measures, local standard of care and approved product 
labeling should be utilized. After the first cycle of chemotherapy, G-CSFs may be used only to 
assist with hematologic recovery. General guidelines for coordinating chemotherapy, 
immunotherapy, and radiotherapy are listed below. 
7.4.5.1 
Etoposide or Pemetrexed + Platinum Regimens 
1) During the CCRT Period, systemic anticancer therapy begins on Day 1 of Cycle 1 and 
radiotherapy begins on Day 1 of Cycle 2. However, if radiotherapy planning is complete prior 
to the initiation of systemic anticancer therapy at Cycle 1 (Arms A, B, or C), the investigator 
has the option to skip Cycle 1 of systemic anticancer therapy alone, and initiate treatment with 
radiotherapy concurrently with systemic anticancer therapy (Cycle 2). All study procedures for 
Cycle 2 and Cycle 3 during the CCRT period are still to be followed. An additional cycle of 
consolidation systemic anticancer therapy will not be administered after the completion of 
radiotherapy in this situation. 
2) When radiotherapy is initiated, systemic anticancer therapy and radiotherapy should be 
administered on the same day (i.e. Day 1), with radiotherapy administered after the completion 
of systemic anticancer therapy, if logistically feasible. Otherwise, a ± 3 day window will be 
permitted for the initiation of radiotherapy. For participants randomized to Arms A or B, 
chemotherapy must be administered after the completion of nivolumab administration AND 
on the same day nivolumab is administered. 
3) Repeated chemotherapy dose delays are allowed if needed. If a single chemotherapy agent is 
delayed, the other chemotherapy agent(s) and nivolumab should be delayed. Nivolumab may 
resume only when criteria to resume both chemotherapy and nivolumab are met. 
4) In the case that systemic anticancer therapy was administered during Cycle 1: 
a) If Cycle 2 chemotherapy is delayed, radiotherapy should not be initiated, and nivolumab 
not administered (in Arms A and B), until chemotherapy is resumed. Participants should 
be monitored at least on a weekly basis. If Cycle 2 chemotherapy is delayed for >3 weeks, 
then Cycle 2 chemotherapy should be skipped, and radiotherapy should be administered. 
The date of the first radiotherapy dose is defined as C2D1. 
b) If Cycle 2 chemotherapy is skipped, participants may receive nivolumab treatment on 
C2D1 for Arms A and B (± 3 days of initiation of radiotherapy). 
c) If Cycle 2 chemotherapy is discontinued, in Arms A and B, participants may receive 
nivolumab treatment on C2D1 (± 3 days of initiation of radiotherapy), and C3D1 (± 3 days 
of continuation of radiotherapy). 

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5) Regardless of whether Cycle 1 systemic anticancer therapy is skipped or not: 
a) If Cycle 3 chemotherapy is delayed, in Arms A and B, nivolumab should be delayed, but 
radiotherapy should continue as scheduled. 
b) If participant meets criteria to resume chemotherapy, chemotherapy (and nivolumab in 
Arms A and B) may be administered at any time during radiotherapy in Cycle 3. 
c) If Cycle 3 chemotherapy is discontinued, participants in Arms A and B may receive 
nivolumab treatment at any time during radiotherapy in Cycle 3. 
d) After the end of radiotherapy, any planned remaining systemic anticancer therapy that has 
yet to be dosed should be omitted. 
 
7.4.5.2 
Paclitaxel + Carboplatin Regimen 
1) During the CCRT Period, systemic anticancer therapy begins on Day 1 of Cycle 1 and 
radiotherapy begins on Day 1 of Cycle 2. However, if radiotherapy planning is complete prior 
to the initiation of systemic anticancer therapy at Cycle 1 (Arms A, B, or C), the investigator 
has the option to skip Cycle 1 of systemic anticancer therapy alone, and initiate treatment with 
radiotherapy concurrently with systemic anticancer therapy (Cycle 2). All study procedures for 
Cycle 2 and Cycle 3 during the CCRT period are still to be followed. An additional cycle of 
consolidation systemic anticancer therapy will not be administered after the completion of 
radiotherapy in this situation. 
2) When radiotherapy is initiated, systemic anticancer therapy and radiotherapy should be 
administered on the same day (i.e. Day 1), with radiotherapy administered after the completion 
of systemic anticancer therapy, if logistically feasible. Otherwise, a ± 3 days window will be 
permitted for the initiation of radiotherapy. For participants randomized to Arms A or B, 
chemotherapy must be administered after the completion of nivolumab administration AND 
on the same day nivolumab is administered. 
3) Repeated chemotherapy dose delays are allowed if needed. If a single chemotherapy agent is 
delayed, the other chemotherapy agent(s) and nivolumab should be delayed. Nivolumab may 
resume only when criteria to resume both chemotherapy and nivolumab are met. 
4) In the case that systemic anticancer therapy was administered during Cycle 1: 
a) If Cycle 2 chemotherapy is delayed, radiotherapy should not be initiated, and nivolumab 
not administered (in Arms A and B), until chemotherapy is resumed. Participants should 
be monitored at least on a weekly basis. Carboplatin + paclitaxel treatment in Cycle 2 and 
Cycle 3 entails 3 weekly doses in each cycle. Weekly doses that are delayed by more than 
1 week should be skipped and the next weekly dose administered when criteria to resume 
chemotherapy are met. If Cycle 2 chemotherapy is delayed for >3 weeks, then Cycle 2 
Day 1 chemotherapy should be skipped, and radiotherapy should be administered. The date 
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b) If Cycle 2 Day 1 chemotherapy is skipped, participants may receive nivolumab treatment 
on C2D1 (± 3 days of initiation of radiotherapy) in Arms A and B. If remaining weekly 
chemotherapy within C2 can resume afterwards, chemotherapy doses may be administered. 
From C2D8 onwards, if weekly chemotherapy is delayed beyond 7 days, this weekly 
chemotherapy should be skipped; if chemotherapy can’t resume beyond two consecutive 
weeks, the chemotherapy should be discontinued. 
c) If Cycle 2 chemotherapy is discontinued, participants may receive nivolumab treatment on 
C2D1 (± 3 days of initiation of radiotherapy), and C3D1 (± 3 days of continuation of 
radiotherapy). 
5) If Cycle 1 systemic anticancer therapy was skipped: 
a) From C2D8 and onwards, if weekly chemotherapy is delayed beyond 7 days, this weekly 
chemotherapy should be skipped; if chemotherapy can’t resume beyond two consecutive 
weeks, the chemotherapy should be discontinued. 
6) Regardless of whether Cycle 1 systemic anticancer therapy is skipped or not: 
a) If Cycle 3 Day 1 chemotherapy is delayed, nivolumab (in Arms A and B) should be 
delayed, but radiotherapy should continue as scheduled. 
b) If participant meets criteria to resume chemotherapy, chemotherapy (and nivolumab in 
Arms A and B) may be administered at any time during radiotherapy in Cycle 3 and the 
dose resumption date is defined as C3D1. 
c) If the criteria to resume the remaining weekly chemotherapy within Cycle 3 are met, 
remaining C3D8 and/or C3D15 chemotherapy may be resumed as long as radiotherapy 
does not come to an end. 
d) If Cycle 3 chemotherapy is discontinued, participants in Arms A and B may receive 
nivolumab treatment at any time during radiotherapy in Cycle 3. 
e) After the end of radiotherapy, any planned remaining systemic anticancer therapy that has 
yet to be dosed should be omitted. 
 
Chemotherapy toxicity may be managed per local standards. The following tables provide 
recommended delay and dose modifications for the following toxicities with cisplatin/carboplatin 
+ etoposide or pemetrexed: Table 7.4.5.3-1 (Hematologic); Table 7.4.5.4-1 (Hepatic); 
Table 7.4.5.5-1 (Renal-Cisplatin); Table 7.4.5.5-2 (Renal-Carboplatin); and Table 7.4.5.6-1 (Other 
toxicities). Toxicity management recommendations for the carboplatin + paclitaxel regimen is 
provided in Section 7.4.5.7. 

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7.4.5.3 
Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose Modifications 
for Hematologic Toxicity 
Dose modifications for hematologic toxicity are based on each pre-treatment blood count. 
Table 7.4.5.3-1: 
Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose 
Modifications for Hematological Toxicity 
 
ANC x 109/l 
Platelets x 109/l 
Cisplatin + Etoposide or Cisplatin + Pemetrexed 
Carboplatin + Etoposide or Carboplatin + Pemetrexed 
> 1.5 at day 1 of cycle 
and 
>100 
Full dose 
≤ 1.5 at day 1 of cycle 
or 
≤100 
Delay until recovery ANC > 1.5 and platelets >100 
Febrile neutropenia 
episode or treatment 
delay for grade 4 
neutropenia > 7 days 
Delay until recovery ANC > 1.5 and platelets >100 
First event: full dose and G-CSF support is recommended. 
Second event (or if G-CSF support was already delivered): 
20% dose reduction of both drugs and continuing G-CSF 
support. 
Grade 4 
thrombocytopenia 
requiring medical 
intervention or 
grade ≥ 2 
bleeding with 
thrombocytopenia 
Delay until recovery ANC > 1.5 and platelets > 100 
First event: 20% dose reduction of both drugs 
Second event: 35% dose reduction of both drugs 
Abbreviations: ANC, absolute neutrophil count; G-CSF, granulocyte colony-stimulating factor. 
 
7.4.5.4 
Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose Modifications 
for Hepatic Toxicity 
It is possible that radiation may lead to abnormal liver function tests especially for lesions in the 
lower part of right lung. If these abnormalities are believed to be related to radiation only, no dose 
modification for chemotherapy is necessary. 

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Table 7.4.5.4-1: 
Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose 
Modifications for Hepatic Toxicity 
 
AST/ALT 
Bilirubin 
Cisplatin or Carboplatin 
Etoposide or Pemetrexed 
2-5 x ULN at 
day 1 of cycle 
and 
≤2 x ULN 
Full dose 
Full dose 
> 5 x ULN at 
day 1 of cycle 
or 
> 2 x ULN 
Delay one week then reassess using the same criteria. 
A delay up to three weeks is allowed (if a longer delay is necessary trial 
treatment must be stopped). 
First event: 20% dose reduction of etoposide at cycle 2 (or cycle 3 if 
first cycle systemic therapy is skipped), no reduction in carboplatin. 
Second event: 35% dose reduction of etoposide at cycle 3 (only 
applicable if systemic therapy is initiated at cycle 1). 
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal. 
 
7.4.5.5 
Cisplatin/Carboplatin + Etoposide or Pemetrexed Dose Modifications 
for Renal toxicity 
Dose modifications for renal toxicity are shown in Table 7.4.5.5-1 for cisplatin and 
Table 7.4.5.5-2 for carboplatin. The calculated creatinine clearance should be determined before 
each course of chemotherapy. 
Table 7.4.5.5-1: 
Cisplatin-based Chemotherapy Dose Modifications for Renal 
Toxicity (with Etoposide or Pemetrexed) 
 
Calculated Creatinine 
Clearance at day 1 of Cycle 
Cisplatin 
Etoposide or Pemetrexed 
> 50 ml/min 
Full dose 
Full dose 
20-50 ml/min 
Switch to carboplatin AUC 5 
If pemetrexed is used, switch to etoposide 
with 25% dose reduction if < 45ml/min 
< 20 ml/min 
Off treatment 
Off treatment 
Abbreviation: AUC, area under the concentration-time curve. 
 
Carboplatin-based chemotherapy dose modifications for renal toxicity are shown in 
Table 7.4.5.5-2. 
Table 7.4.5.5-2: 
Carboplatin-based Chemotherapy Dose Modifications for Renal 
Toxicity (with Etoposide or Pemetrexed) 
 
Calculated creatinine 
clearance at day 1 of cycle 
Carboplatin 
Etoposide or Pemetrexed 
> 50 ml/min 
Full dose 
Full dose 
20-50 ml/min 
Full dose 
If pemetrexed is used, switch to etoposide 
with 25% dose reduction if < 45ml/min 
< 20 ml/min 
Off treatment 
Off treatment 

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7.4.5.6 
Other toxicities with Cisplatin/Carboplatin + Etoposide or Pemetrexed 
Other toxicities during treatment with cisplatin or carboplatin with etoposide or pemetrexed are 
listed in Table 7.4.5.6-1. 
Table 7.4.5.6-1: 
Dose modifications for other toxicities with Cisplatin/Carboplatin + 
Etoposide or Pemetrexed 
 
Severity 
Modification 
Peripheral neuropathy grade > 2 
Switch to carboplatin AUC5 
100% dose of etoposide 
Grade 3-4 mucositis 
50% dose of pemetrexed 
Any grade 3-4 toxicities other than 
mucositis, nausea/vomiting, fatigue or 
alopecia 
• 
25% dose reduction for cisplatin/carboplatin and etoposide, or 
pemetrexed after recovery to grade ≤1. 
• 
A delay up to three weeks is allowed (if a longer delay is 
necessary treatment must be stopped). 
Abbreviation: AUC, area under the concentration-time curve. 
 
7.4.5.7 
Dose Modifications for Toxicities with Carboplatin + Paclitaxel Regimen 
Dose modification entails dose delay, skipping, and discontinuation. There are no dose reductions 
unless required by local standards. Hematological and non-hematological toxicities are listed in 
Table 7.4.5.7-1 and Table 7.4.5.7-2, respectively. 
Table 7.4.5.7-1: 
Carboplatin + Paclitaxel Dose Modifications for Hematological 
Toxicities 
 
Severity 
Paclitaxel 
Carboplatin 
Thrombocytopenia grade > 1 
Hold until grade ≤ 1 
Hold until grade ≤ 1 
Other hematological toxicities grade ≥ 3 except for 
leukopenia and lymphopenia 
Hold until grade ≤ 2 
Hold until grade ≤ 2 
 
Table 7.4.5.7-2: 
Carboplatin + Paclitaxel Dose Modifications for Non-Hematological 
Toxicities 
 
Severity 
Paclitaxel 
Carboplatin 
Neuropathy grade 2 
Neuropathy grade ≥ 3 
Hold until grade ≤ 1 
Discontinue 
Maintain dose 
Discontinue 
Febrile neutropenia 
Hold 
Hold 
CrCl < 20 ml/min 
Maintain dose 
Discontinue 
Allergic reaction grade ≥ 3 
Discontinue 
Discontinue 
Other non-hematological toxicities grade ≥ 3 
Hold until grade ≤ 2 
Hold until grade ≤ 2 
Abbreviation: CrCl, creatinine clearance. 

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If weekly low dose chemotherapy cannot resume beyond 7 days, this dose should be skipped. If 
weekly dose cannot resume beyond 2 consecutive weeks, chemotherapy should be permanently 
discontinued. 
7.4.6 
Radiotherapy Dose Modification 
In principle, radiotherapy should continue with ≤ Grade 3 non-hematological toxicities and should 
be held for Grade 4 non-hematological toxicities, then resume when toxicities resolve to ≤ Grade 2. 
Holding radiotherapy for Grade 4 hematological toxicities other than lymphopenia and leukopenia 
may be considered. 
7.4.6.1 
Esophagitis from Radiotherapy 
Esophageal complaints are common with combined modality therapy. Esophagitis does not 
constitute a reason to interrupt or delay radiotherapy or chemotherapy provided oral intake is 
sufficient to maintain hydration. Participants should be advised to avoid alcoholic, acidic, or spicy 
foods or beverages. Viscous xylocaine, carafate, or other medications should be used for 
symptomatic relief. As the esophageal transit time is clearly prolonged with radiotherapy and 
reflux may occur, the use of PPIs or H2 antagonists is recommended. Opioids may be required, 
especially in managing high grade esophagitis. In case of Grade 2 esophagitis occurring during the 
first 2 weeks of radiotherapy, a fungal infection, mainly candida albicans, may have occurred. 
Treatment with anti-fungal agents such as nystatin or fluconazole should be considered. 
Acute esophagitis may persist for 4-6 weeks. If Grade 4 esophagitis occurs, and a treatment 
interruption is being considered, every effort should be made to limit it to ≤ 3 treatment days. 
Participants requiring hospitalization because of esophagitis may have their treatment interrupted. 
Acute esophageal toxicity should be pharmacologically managed with the recommended treatment 
options per local standard practice and should be initiated at the first signs or symptoms of esophageal 
toxicity. See Table 7.4.6.4-1 for recommended management of high grade esophagitis. 
7.4.6.2 
Pulmonary Toxicity from Radiotherapy 
See Table 7.4.6.4-1. 
7.4.6.3 
Skin Toxicity from Radiotherapy 
See Table 7.4.6.4-1. 
7.4.6.4 
Combined Chemoradiotherapy Dose Modifications 
Table 7.4.6.4-1: 
Chemoradiotherapy Modifications for In-Field Toxicities 
 
Toxicity 
CTCAE v 4.0 
Grade 
Radiotherapy 
Chemotherapy 
Esophagus/pharynx 
4 
Hold treatment until ≤ Grade 2 
Hold treatment until ≤ Grade 2 
Esophagus/pharynx 
3 
No change or hold ≤ 5 days 
Hold treatment until ≤ Grade 2 
Esophagus/pharynx 
2 
No change 
No change 

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Table 7.4.6.4-1: 
Chemoradiotherapy Modifications for In-Field Toxicities 
 
Pulmonary 
4 
Discontinue 
Discontinue 
Pulmonary 
3 
Consider to hold until ≤ Grade 2 
Consider to hold until ≤ Grade 2 
Skin 
4 
Hold treatment until ≤ Grade 2 
Hold treatment until ≤ Grade 2 
Skin 
3 
No change 
No change 
Abbreviation: CTCAE v 4.0, Common Terminology Criteria for Adverse Events version 4.0. 
 
Additional chemoradiotherapy modifications are as follows: 
1) If treatment is interrupted ≥ 3 weeks for pneumonitis, discontinue all protocol therapy in CCRT 
period. 
2) In case of interruptions due to machine breakdown or public holidays or any interruptions of 
therapy up to 7 days, radiation should be completed to the prescribed doses. Total number of 
fractions and elapsed days should be carefully reported 
3) In the case of Grade 3 esophagitis related to the concomitant treatment, chemotherapy should 
be suspended if the investigator believes continued use will jeopardize the delivery of full-dose 
radiotherapy; radiation is to be continued 
 
7.5 
Preparation/Handling/Storage/Accountability 
The investigational product should be stored in a secure area according to local regulations. It is 
the responsibility of the investigator, or designee where permitted, to ensure that investigational 
product is only dispensed to study Participants. The investigational product must be dispensed 
only from official study sites by authorized personnel according to local regulations. 
The product storage manager should ensure that the study treatment is stored in accordance with 
the environmental conditions (temperature, light, and humidity) as determined by BMS. If 
concerns regarding the quality or appearance of the study treatment arise, the study treatment 
should not be dispensed and contact BMS immediately. 
Study treatment not supplied by BMS will be stored in accordance with the approved Product 
Label. 
Investigational product documentation (whether supplied by BMS or not) must be maintained that 
includes all processes required to ensure drug is accurately administered. This includes 
documentation of drug storage, administration and, as applicable, storage temperatures, 
reconstitution, and use of required processes (eg, required diluents, administration sets). 
• Further guidance and information for final disposition of unused study treatment are provided 
in Appendix 2 and CA20973L Study Manual. 

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7.6 
Treatment Compliance 
Study treatment compliance will be periodically monitored by drug accountability. Study 
treatment will be administered in the clinic by trained personnel. Drug accountability should be 
reviewed by the site study staff at each visit to confirm treatment compliance. 
7.7 
Concomitant Therapy 
7.7.1 
Prohibited and/or Restricted Treatments 
The following medications are prohibited and/or restricted during the study (unless utilized to treat 
a drug-related adverse event or as premedication): 
• Immunosuppressive agents 
• Immunosuppressive doses of systemic corticosteroids (except as stated in Section 7.7.3) 
• Any concurrent anti-neoplastic therapy other than specified as study treatments (ie, 
chemotherapy, hormonal therapy, immunotherapy, extensive, non-palliative radiation therapy, 
or standard or investigational agents for treatment of NSCLC) 
• Any complementary medications (eg, herbal supplements or traditional Chinese medicines) 
intended to treat the disease under study or provide supportive care. Use of marijuana and its 
derivatives for treatment of symptoms related to cancer or cancer treatment are permitted if 
obtained by medical prescription or if its use (even without a medical prescription) has been 
legalized locally 
• Any live/attenuated vaccine (eg, varicella, zoster, yellow fever, rotavirus, oral polio, and 
measles, mumps, rubella [MMR]) during treatment and until 100 days post last dose 
• Investigators should refer to the approved local product labeling for the chemotherapy drugs 
for additional prohibited and restricted concomitant medications. After the first cycle of 
chemotherapy, prophylactic G-CSFs can be administered only to assist with hematologic 
recovery. 
 
7.7.2 
Prior and Concomitant Medications 
Any medications (prescription and OTC), vitamin and mineral supplements, and/or herbs taken by 
the participant from screening through the treatment phase of the study will be documented and 
recorded, including start and stop date, dose and route of administration, frequency, and indication. 
Medications taken for any procedure are encouraged to be included. 
COVID-19 vaccines that are NOT live are allowed and should be handled in the same manner as 
other vaccines. Administration may occur during the study. 
7.7.3 
Other Restrictions and Precautions 
Participants are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational 
corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses > 10 mg 
daily of prednisone are permitted. A brief (less than 3 weeks) course of corticosteroids for 
prophylaxis (eg, contrast dye allergy) or for treatment of non-autoimmune conditions (eg, 
delayed-type hypersensitivity reaction caused by a contact allergen) is permitted. 
Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg 
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randomization are excluded. Inhaled or topical steroids, and adrenal replacement steroid doses 
> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 
7.7.4 
Imaging Restriction and Precaution 
It is the local imaging facility’s responsibility to determine, based on participant attributes 
(eg, allergy history, diabetic history, and renal status), the appropriate imaging modality and 
contrast regimen per imaging study. Imaging contraindications and contrast risks are to be 
considered in this assessment. Participants with renal insufficiency are to be assessed as to whether 
or not they should receive contrast and if so, which contrast agent and dose is appropriate. Specific 
to MRI, participants with severe renal insufficiency (ie, estimated glomerular filtration rate (eGFR) 
< 30 mL/min/1.73 m2) are at increased risk of nephrogenic systemic fibrosis and MRI contrast is 
contraindicated. In addition, participants may be excluded from MRI if they have tattoos, metallic 
implants, pacemakers, etc. This will be outlined in the image acquisition manual. 
Gentle hydration before and after IV contrast should follow local standard of care. The ultimate 
decision to perform MRI in an individual participant in this study rests with the site radiologist, 
the investigator, and standards set by the local Ethics Committee. 
7.8 
Treatment After the End of the Study 
At the end of the study, BMS will not continue to provide BMS supplied study treatment to 
participants/investigators unless BMS chooses to extend the study. The investigator should ensure 
that the participant receives appropriate standard of care to treat the condition under study. 
BMS reserves the right to terminate access to BMS supplied study treatment if any of the following 
occur: a) the study is terminated due to safety concerns; b) the development of study drug is 
terminated for other reasons, including, but not limited to, lack of efficacy and/or not meeting the 
study objectives; c) the participant can obtain medication from a government-sponsored or private 
health program. In all cases, BMS will follow local regulations. 
8 
DISCONTINUATION CRITERIA 
8.1 
Discontinuation from Study Treatment 
Participants MUST discontinue investigational product (and non-investigational product at the 
discretion of the investigator) for any of the following reasons: 
• Participant’s request to stop study treatment. Participants who request to discontinue study 
treatment will remain in the study and must continue to be followed for protocol specified 
follow-up procedures. The only exception to this is when a participant specifically withdraws 
consent for any further contact with him/her or persons previously authorized by participant to 
provide this information. 
• Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the 
opinion of the investigator, indicates that continued participation in the study is not in the best 
interest of the participant 
• Completion of the course of study treatment 
• Termination of the study by Bristol-Myers Squibb (BMS) 

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• Loss of ability to freely provide consent through imprisonment or involuntarily incarceration 
for treatment of either a psychiatric or physical (eg, infectious disease) illness. (Note: Under 
specific circumstances, a participant who has been imprisoned may be permitted to continue 
on the study. Strict conditions apply and BMS approval is required.) 
• Disease progression in the absence of clinical benefit as determined by the Investigator 
• See Section 8.1.1, Section 8.1.2, Section 8.1.3, Section 8.1.4, and Section 8.1.5 for 
discontinuation criteria for nivolumab, ipilimumab, durvalumab, chemotherapy, and CCRT, 
respectively. 
• Noncompliance of the participant with protocol-mandated procedures based on the judgment 
and agreement of both the Investigator and Sponsor 
 
If a participant has not progressed following discontinuation of study treatment(s), every effort 
should be made to continue to obtain radiographic tumor assessments until BICR confirmed 
progression and Investigator-assessed distant metastases. 
A participant may also be withdrawn from investigational product/study by the Sponsor, 
Regulatory Authorities, or Institutional Review Boards (IRBs)/ Independent Ethics Committees 
(IECs). 
Participants may choose to discontinue the study at any time, for any reason, and without prejudice 
to further treatment. 
Refer to Section 2: Schedule of Activities for data which must be collected at the time of treatment 
discontinuation and follow-up and for any further evaluations that can be completed. 
In the case of pregnancy, the investigator must immediately, within 24 hours of awareness of the 
pregnancy, notify the BMS Medical Monitor/designee of this event. In most cases, the study 
treatment will be permanently discontinued in an appropriate manner (eg, dose tapering if 
necessary for participant safety). 
All participants who discontinue study treatment should comply with protocol specified follow-up 
procedures as outlined in Table 2-8. The only exception to this requirement is when a participant 
withdraws consent for all study procedures including post-treatment study follow-up or loses the 
ability to consent freely (ie, is imprisoned or involuntarily incarcerated for the treatment of either 
a psychiatric or physical illness). 
If study treatment is discontinued prior to the participant’s completion of the study, the reason for 
the discontinuation must be documented in the participant’s medical records per local regulatory 
requirements in each region/country and entered on the appropriate case report form (eCRF) page. 
8.1.1 
Discontinuation Criteria for Nivolumab 
Treatment with nivolumab should be permanently discontinued for any of the following: 
• Any Grade 2 drug-related uveitis, eye pain, or blurred vision that does not respond to topical 
therapy and does not improve to Grade 1 severity within the retreatment period OR requires 
systemic treatment 

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• Any Grade 3 non-skin, drug-related AE lasting > 7 days or recurs, with the following 
exceptions for laboratory abnormalities, drug-related uveitis, pneumonitis, bronchospasm, 
neurologic toxicity, myocarditis, hypersensitivity reactions, infusion reactions, and 
endocrinopathies: 
− Grade 3 drug-related uveitis, pneumonitis, bronchospasm, neurologic toxicity, myocarditis, 
hypersensitivity reaction, or infusion reaction of any duration requires discontinuation 
− Grade 3 drug-related endocrinopathies, adequately controlled with only physiologic 
hormone replacement do not require discontinuation. Adrenal insufficiency requires 
discontinuation regardless of control with hormone replacement. 
− Grade 3 drug-related laboratory abnormalities do not require treatment discontinuation 
except: 
♦ Grade 3 drug-related thrombocytopenia > 7 days or associated with bleeding requires 
discontinuation 
♦ Grade ≥ 3 drug-related AST, ALT or total bilirubin requires discontinuation* 
♦ Concurrent AST or ALT > 3 x ULN and total bilirubin > 2x ULN 
* In most cases of Grade 3 AST or ALT elevation, study treatment(s) will be permanently 
discontinued. If the investigator determines a possible favorable benefit/risk ratio that warrants 
continuation of study treatment(s), a discussion between the investigator and the BMS medical 
monitor or designee must occur. 
• Any Grade 4 drug-related adverse event or laboratory abnormality (including but not limited 
to creatinine, AST, ALT, or total bilirubin), except for the following events which do not 
require discontinuation: 
− Grade 4 neutropenia ≤ 7 days 
− Grade 4 lymphopenia or leukopenia or asymptomatic amylase or lipase 
− Isolated Grade 4 electrolyte imbalances/abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 72 hours 
of their onset 
− Grade 4 drug-related endocrinopathy adverse events, such as, hyper- or hypothyroidism, 
or glucose intolerance, which resolve or are adequately controlled with physiologic 
hormone replacement (corticosteroids, thyroid hormones) or glucose-controlling agents, 
respectively, may not require discontinuation after discussion with and approval from the 
BMS Medical Monitor. 
• Any event that leads to delay in dosing lasting > 8 weeks from the previous dose requires 
discontinuation (exception is for nivolumab 480 mg Q4W where the delay can last up to 
10 weeks), with the following exceptions: 
− Dosing delays to allow for prolonged steroid tapers to manage drug-related adverse events 
are allowed. 
− Dosing delays lasting > 8 weeks from the previous dose (> 10 weeks for nivolumab 480 mg 
Q4W) that occur for non-drug-related reasons may be allowed if approved by the BMS 
Medical Monitor (or designee). 

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Prior to re-initiating treatment in a participant with a dosing delay lasting > 8 weeks (> 10 weeks 
for nivolumab 480 mg Q4W), the BMS Medical Monitor (or designee) must be consulted. Tumor 
assessments should continue as per protocol even if dosing is delayed. Periodic study visits to 
assess safety and laboratory studies should also continue every 6 weeks or more frequently if 
clinically indicated during such dosing delays. 
Nivolumab should be discontinued for any adverse event, laboratory abnormality, or intercurrent 
illness which, in the judgment of the Investigator, presents a substantial clinical risk to the 
participant with continued nivolumab dosing. 
NOTE: For participants in Arm A, during the Maintenance Period, receiving nivolumab in 
combination with ipilimumab, the assessment for discontinuation of nivolumab should be made 
separately from the assessment made for discontinuation of ipilimumab. Although there is overlap 
among the discontinuation criteria, if discontinuation criteria are met for ipilimumab but not for 
nivolumab, treatment with nivolumab may continue if ipilimumab is discontinued. 
If a participant meets criteria for discontinuation and the investigator is unable to determine 
whether the event is related to nivolumab, or ipilimumab, the participant should discontinue all 
treatment: and be taken off the treatment phase of the study. Continuation of ipilimumab after 
discontinuation of nivolumab is not allowed on study. 
8.1.2 
Ipilimumab Discontinuation Criteria 
Ipilimumab should be permanently discontinued if any of the following criteria are met: 
• Any Grade ≥ 2 drug-related uveitis or eye pain or blurred vision that does not respond to topical 
therapy and does not improve to Grade 1 severity within 2 weeks OR requires systemic 
treatment; 
• Any Grade ≥ 3 bronchospasm or other hypersensitivity reaction; 
• Any other Grade 3 non-skin, drug-related adverse with the following exceptions for laboratory 
abnormalities, grade ≥ 3 nausea and vomiting, grade 3 neutropenia and thrombocytopenia, and 
symptomatic endocrinopathies which resolved (with or without hormone substitution); 
• Any drug-related liver function test (LFT) abnormality that meets the following criteria require 
discontinuation: 
− Grade ≥ 3 drug related AST, ALT or total bilirubin required discontinuation 
♦ In most cases of Grade 3 AST, ALT evaluation study treatment(s) will be permanently 
discontinued. If the investigator determines a possible favorable benefit/risk ratio that 
warrants continuation of study treatment(s), a discussion between the investigator and 
the BMS medical monitor or designee must occur. 
− Concurrent AST or ALT > 3 x ULN and total bilirubin > 2X ULN 
• Any Grade 4 drug-related adverse event or laboratory abnormality, except for the following 
events, which do not require discontinuation: 
− Grade 4 neutropenia ≤ 7 days 
− Grade 4 lymphopenia or leukopenia 

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− Isolated Grade 4 amylase or lipase abnormalities which are not associated with symptoms 
or clinical manifestations of pancreatitis. 
− Isolated Grade 4 electrolyte imbalances/abnormalities that are not associated with clinical 
sequelae and are corrected with supplementation/appropriate management within 72 hours 
of their onset 
− Grade 4 drug-related endocrinopathy adverse events such as adrenal insufficiency, ACTH 
deficiency, hyper- or hypothyroidism, or glucose intolerance, which resolve or are 
adequately controlled with physiologic hormone replacement (corticosteroids, thyroid 
hormones) or glucose controlling agents, respectively, may not require discontinuation 
after discussion with and approval from the BMS Medical Monitor. 
• Any treatment delay resulting in no ipilimumab dosing for > 12 weeks with the following 
exceptions: Dosing delays to manage drug-related adverse events, such as prolonged steroid 
tapers, are allowed. Prior to re-initiating treatment in a participant with a dosing delay lasting 
> 12 weeks, the BMS medical monitor must be consulted. Tumor assessments should continue 
as per protocol even if dosing is delayed. 
• Any adverse event, laboratory abnormality, or intercurrent illness which, in the judgment of 
the Investigator, presents a substantial clinical risk to the participant with continued 
ipilimumab dosing 
 
The assessment for discontinuation of ipilimumab should be made separately from the assessment 
made for discontinuation of nivolumab. Although there is overlap among the discontinuation 
criteria, if discontinuation criteria are met for ipilimumab but not for nivolumab, treatment with 
nivolumab may continue if ipilimumab is discontinued. 
If a participant meets criteria for discontinuation and the investigator is unable to determine 
whether the event is related to nivolumab or ipilimumab, the participant should discontinue 
nivolumab and ipilimumab. 
8.1.3 
Durvalumab Discontinuation Criteria 
The toxicity management strategy for durvalumab (see Section 7.4.3) may lead to discontinuation 
or resumption of durvalumab upon clinical outcomes. See local approved prescribing information 
for durvalumab. 
8.1.4 
Discontinuation Criteria for Chemoradiotherapy 
As highlighted in dose modification for chemotherapy (see Section 7.4.5) and chemoradiation (see 
Section 7.4.6), despite diligent management, if toxicities remain unmanageable, components in 
question should be discontinued. 
Specifically, one or both chemotherapy components should be discontinued for any of the 
following: 
• Grade ≥3 drug-related thrombocytopenia associated with clinically significant bleeding 
• Any drug-related grade 3/4 adverse event (eg, ANC, PLT) which recurs after two prior dose 
reductions for the same drug related adverse event requires discontinuation of the drug(s) 
which was/were previously dose reduced 

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• Any drug-related liver function test (LFT) abnormality that meets the following criteria: 
− AST or ALT > 5-10x ULN for > 2 weeks 
− AST or ALT > 10x ULN 
− Total bilirubin > 5 x ULN 
− Concurrent AST or ALT > 3 x ULN and total bilirubin > 2 x ULN 
• Any Grade ≥ 3 drug-related hypersensitivity reaction or infusion reaction requires 
discontinuation of the drug(s) that is suspected to be causing the reaction. The drug(s) not 
suspected to be related to the hypersensitivity reaction or infusion reaction may be continued 
• In case of renal toxicity, if CrCl ≤ 50 mL/min but ≥ 20 mL/min, cisplatin should be 
discontinued and a switch to carboplatin at AUC 5 could be opted for. In addition, participants 
receiving cisplatin with pemetrexed must discontinue cisplatin if the calculated creatinine 
clearance decreases to < 50 mL/min (based on the Cockcroft Gault formula). The other drug 
(pemetrexed) may be continued, and the platinum agent may, at the investigator’s discretion, 
be switched to carboplatin for the remainder of the platinum-based doublet cycles when the 
participant meets retreatment criteria. Carboplatin should be discontinued if CrCl < 20 
mL/min. In case of CrCl < 45 mL/min, pemetrexed should be discontinued and may be 
substituted with etoposide with 25% dose reduction. In case of CrCl < 20 mL/min, any 
chemotherapy should be stopped 
• Participants with non-hematologic toxicities ≥ Grade 3 (excluding neurotoxicity), pemetrexed 
should be withheld until resolution to better than or equal to baseline 
• In case of peripheral neuropathy grade > 2, cisplatin should be stopped and be substituted by 
carboplatin at AUC 5. Stop chemotherapy for Grade 3/4 neurotoxicity, except for carboplatin 
which may be withheld until ≤ Grade 2 
• Any Grade 4 drug-related adverse event which the investigator deems inappropriate to be 
managed by dose reduction(s) requires discontinuation of the drug(s) felt to be causing the 
event. The drug not felt to be related to the event may be continued. 
• Regarding rules of dose skipping or discontinuation due to exceeding the maximum dose delay, 
please refer to Section 7.4.5. 
• Any adverse event, laboratory abnormality, or intercurrent illness which, in the judgment of 
the Investigator, presents a substantial clinical risk to the participant with continued 
chemotherapy dosing. Investigators should consult local labeling for the chemotherapy drugs 
being administered to any participant for additional guidance on dose discontinuation. 
 
8.1.5 
Multimodality in CCRT Period Discontinuation Criteria 
In cases where one or a few components in the multimodality therapy meet discontinuation criteria, 
other components may continue as judged appropriate by investigator. It is of ultimate importance 
to try the best to deliver radiotherapy as planned without delay or interruption. Full supportive care 
should be in place. Chemotherapy (and/or nivolumab) may be delayed or discontinued to ensure 
the delivery of radiotherapy. Maintaining the planned cumulative platinum chemotherapy dose 
takes the second priority, followed by nivolumab in Arm A and Arm B. 
8.1.6 
Treatment beyond Progression 
Accumulating evidence indicates a minority of participants treated with immunotherapy may 
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Participants will be permitted to continue maintenance treatment in Arm A, Arm B, and Arm C 
beyond initial RECIST 1.1 defined PD, as assessed by the investigator, for up to a maximum of 
12 months from date of first dose, as long as they meet the following criteria: 
1) Investigator-assessed clinical benefit. 
2) Tolerance of study treatment 
3) Stable performance status 
4) Treatment beyond progression will not delay an imminent intervention to prevent serious 
complications of disease progression (eg, CNS metastases) 
5) Participant provides written informed consent prior to receiving additional maintenance 
treatment. 
6) Crossover between study treatments/arms is not allowed. 
 
All other elements of the main consent including description of reasonably foreseeable risks or 
discomforts, or other alternative treatment options will still apply. 
A radiographic assessment/ scan should be performed within 6 weeks of initial 
investigator-assessed progression to determine whether there has been a decrease in the tumor size 
or continued PD. The assessment of clinical benefit should be balanced by clinical judgment as to 
whether the participant is clinically deteriorating and unlikely to receive any benefit from 
continued treatment with maintenance treatment in Arm A, Arm B, and Arm C. 
If the investigator feels that the participant continues to achieve clinical benefit by continuing 
treatment, the participant should remain on the treatment and continue to receive monitoring 
according to Section 2 (Schedule of Activities). 
For the participants who continue study treatment beyond progression, further progression is 
defined as an additional 10% increase in tumor burden with a minimum 5 mm absolute increase 
from time of initial PD. This includes an increase in the sum of diameters of all target lesions 
and/or the diameters of new measurable lesions compared to the time of initial PD. Treatment 
should be discontinued permanently upon documentation of further progression. 
New lesions are considered measurable at the time of initial progression if the longest diameter is 
at least 10 mm (except for pathological lymph nodes which must have a short axis of at least 
15 mm). Any new lesion considered non-measurable at the time of initial progression may become 
measurable and therefore be included in the tumor burden if the longest diameter increases to at 
least 10 mm (except for pathological lymph nodes which must have a short axis of at least 15 mm). 
In situations where the relative increase in total tumor burden by 10% is solely due to inclusion of 
new lesions which become measurable, these new lesions must demonstrate an absolute increase 
of at least 5 mm. 
8.2 
Discontinuation from the Study 
Participants who request to discontinue study treatment will remain in the study and must continue 
to be followed for protocol specified follow-up procedures. The only exception to this is when a 

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participant specifically withdraws consent for any further contact with him/her or persons 
previously authorized by the participant to provide this information. 
• Participants should notify the investigator of the decision to withdraw consent from future 
follow-up in writing, whenever possible 
• The withdrawal of consent should be explained in detail in the medical records by the 
investigator, as to whether the withdrawal is from further treatment with study treatment only 
or also from study procedures and/or post treatment study follow-up, and entered on the 
appropriate eCRF page 
• In the event that vital status (whether the participant is alive or dead) is being measured, 
publicly available information should be used to determine vital status only as appropriately 
directed in accordance with local law 
• If the participant withdraws consent for disclosure of future information, the sponsor may 
retain and continue to use any data collected before such a withdrawal of consent 
 
In this study, PFS and OS are key endpoints. Post study follow-up is of critical importance and is 
essential to preserving participant safety and the integrity of the study. Participants who 
discontinue study treatment must continue to be followed for collection of outcome and/or survival 
follow-up data as required and in line with Section 5, until death or the conclusion of the study. 
 
BMS may request that survival data be collected on all treated/randomized participants outside of 
the protocol-defined window. At the time of this request, each participant will be contacted to 
determine their survival status unless the participant has withdrawn consent for all contacts or is 
lost to follow-up. 
8.2.1 
Post Study Treatment Follow-up 
In this study, PFS-2 is an important endpoint. Post study follow-up, including subsequent 
treatment/progression, is of critical importance and is essential to preserving participant safety and 
the integrity of the study. Participants who discontinue study treatment must continue to be 
followed (in this study or a rollover study) for collection of outcome and/or survival follow-up 
data as required and in line with Section 5 until death or the conclusion of the study. 
Participants who discontinue study treatment may continue to be followed. 
8.3 
Lost to Follow-Up 
The following actions must be taken if a participant fails to return to the clinic for a required study 
visit: 
• All reasonable efforts must be made to locate participants to determine and report their ongoing 
status. This includes follow-up with persons authorized by the participant. 
• Lost to follow-up is defined by the inability to reach the participant after a minimum of three 
documented phone calls, faxes, or emails as well as lack of response by participant to one 
registered mail letter. All attempts should be documented in the participant’s medical records. 

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• If it is determined that the participant has died, the site will use permissible local methods to 
obtain date and cause of death. 
• If investigator’s use of third-party representative to assist in the follow-up portion of the study 
has been included in the participant’s informed consent, then the investigator may use a 
Sponsor retained third-party representative to assist site staff with obtaining participant’s 
contact information or other public vital status data necessary to complete the follow-up 
portion of the study. 
• The site staff and representative will consult publicly available sources, such as public health 
registries and databases, in order to obtain updated contact information. 
• If after all attempts, the participant remains lost to follow-up, then the last known alive date as 
determined by the investigator should be reported and documented in the participant’s medical 
records. 
 
9 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and timing are summarized in Section 2: Schedule of Activities. 
• Protocol waivers or exemptions are not allowed. 
• All immediate safety concerns must be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or discontinue 
treatment. 
• Adherence to the study design requirements, including those specified in Section 2: Schedule 
of Activities, is essential and required for study conduct. 
• All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria before randomization. The investigator will maintain a 
screening log to record details of all participants screened and to confirm eligibility or record 
reasons for screening failure, as applicable. 
• Procedures conducted as part of the participant’s routine clinical management (eg, blood count) 
and obtained before signing of informed consent may be utilized for screening or baseline 
purposes provided the procedure meets the protocol-defined criteria and has been performed 
within the timeframe defined in the Schedule of Activities. 
 
Additional measures, including non-study required laboratory tests, should be performed as 
clinically indicated or to comply with local regulations. Laboratory toxicities (eg, suspected drug 
induced liver enzyme evaluations) will be monitored during the follow-up phase via on-site/local 
labs until all study treatment-related toxicities resolve, return to baseline, or are deemed 
irreversible. 
If a participant shows pulmonary-related signs (hypoxia, abnormal heart rate or changes from 
baseline) or symptoms (eg, dyspnea, cough, chest pain, fatigue, palpitations) consistent with 
possible pulmonary adverse events, the participant should be immediately evaluated to rule out 
pulmonary toxicity, according to the suspected pulmonary toxicity management algorithm in the 
BMS-936558 (nivolumab) Investigator Brochure (and in Appendix 6). 

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Some of the assessments referred to in this section may not be captured as data in the eCRF. They 
are intended to be used as safety monitoring by the treating physician. Additional testing or 
assessments may be performed as clinically necessary or where required by institutional or local 
regulations. 
9.1 
Efficacy Assessments 
9.1.1 
Imaging Assessment for the Study 
Images must be submitted to a central imaging vendor for blinded independent central review 
(BICR). Prior to scanning the first participant sites should be qualified and understand the image 
acquisition guidelines and submission process as outlined in the CA20973L Imaging Manual 
provided by the central imaging vendor. Screening and on study images should be acquired as 
outlined in Section 2 (Schedule of Activities). 
Collect any additional imaging that may demonstrate tumor response or progression (including 
scans performed at unscheduled time points and/or at an outside institution) for RECIST 1.1 tumor 
assessment and submit to central imaging vendor. X-rays and bone scans that clearly demonstrate 
interval progression of disease, for example most commonly as unequivocal lesions that are 
unmistakably new since the prior CT/MRI, should be submitted to central imaging vendor. 
Otherwise, x-rays and bone scans do not need to be submitted centrally. 
9.1.1.1 
Methods of Measurement 
Contrast-enhanced CT of the chest, CT/MRI of the abdomen, and all other known and/or suspected 
sites of disease should be performed for tumor assessments. Images should be acquired with slice 
thickness of 5 mm or less with no intervening gap (contiguous). Every attempt should be made to 
image each participant using an identical acquisition protocol on the same scanner for all imaging 
time points. Tumor measurements should be made by the same investigator or radiologist for each 
assessment whenever possible. Change in tumor measurements and tumor response to guide 
ongoing study treatment decisions will be assessed by the Investigator using the RECIST 1.1 
criteria. 
Should a participant have contraindication for CT intravenous contrast, a non-contrast CT of the 
chest and a contrast-enhanced MRI of the abdomen, and other known/suspected sites of disease 
should be obtained. 
Should a participant have contraindication for both MRI and CT intravenous contrasts, a non- 
contrast CT of the chest and a non-contrast MRI of the abdomen, and other known/suspected sites 
of disease should be obtained. 
Should a participant have contraindication for MRI (eg, incompatible pacemaker) in addition to 
contraindication to CT intravenous contrast, a non-contrast CT of the chest, abdomen, and other 
known/suspected sites of disease is acceptable. 
Use of CT component of a PET-CT scanner: Combined modality scanning such as with PET-CT 
is increasingly used in clinical care, and is a modality/technology that is in rapid evolution; 
therefore, the recommendations outlined here may change rather quickly with time. At present, 
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anatomically-based efficacy assessments and it is therefore suggested that they should not be 
substituted for dedicated diagnostic contrast enhanced CT scans for anatomically-based 
RECIST 1.1 measurements. However, if a site can document that the CT performed as part of a 
PET-CT is of identical diagnostic quality to a diagnostic CT (with IV and oral contrast) then the 
CT portion of the PET-CT can be used for RECIST 1.1 measurements. Note, however, that the 
PET portion of the CT introduces additional data which may bias an investigator if it is not 
routinely or serially performed. 
Bone scan or PET scan is not adequate for assessment of RECIST 1.1 response in target lesions. 
In selected circumstances where such modalities are the sole modality used to assess certain 
non-target organs, those non-target organs may be evaluated less frequently. For example, bone 
scans may need to be repeated only when complete response is identified in target disease or when 
progression in bone is suspected. 
Bone scans may be collected per local standards, as clinically indicated. 
MRI of brain must be acquired as outlined in Section 2 (Schedule of Activities). CT of the Brain 
(without and with contrast) can be performed if MRI is contraindicated or based on Investigator 
discretion. 
9.1.1.2 
Clinical Assessment and Imaging 
Tumor assessments should continue at the same frequency even if dosing is delayed or 
discontinued. Changes in tumor measurements and tumor responses will be assessed by the same 
investigator using RECIST 1.1 criteria. Investigators will report the number and size of new lesions 
that appear while on study. The time point of tumor assessments will be reported on the eCRF 
based on the investigator’s assessment using RECIST 1.1 criteria (see Appendix 8 for specifics of 
RECIST 1.1 criteria to be utilized in this study). Specific to this study, lesions that received 
irradiation during the CCRT Period and remain measurable, continue to be considered measurable. 
Assessments of PR and CR must be confirmed at least 4 weeks (28 days) after initial response. A 
best overall response of SD requires a minimum of 56 days on study from randomization to the 
date of the first imaging assessment. 
Tumor assessment by the Investigator must continue until distant metastases is assessed by the 
Investigator per RECIST 1.1. 
9.1.1.3 
BICR Confirmation of Progression or Recurrence 
Sites should submit all scans to the central imaging vendor on a rolling basis, throughout the 
duration of the study until PD is confirmed by the BICR. BICR of scans will occur on a rolling 
basis, blinded to treatment arm, clinical data, and investigator assessment of submitted scans. 
When progression per RECIST 1.1 criteria is assessed by the investigator, the site will inform the 
central imaging vendor, in order for BICR assessment of progression to be performed. The BICR 
review will be completed and the results provided to the site as specified in the imaging vendor 
documents, provided there are no pending imaging queries to the site. All details on the timelines 
and associated process requirements will be outlined in the Imaging Manual. 

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Participants whose progression is not confirmed by the BICR will be required to continue tumor 
assessments (if clinically feasible) according to the protocol-specified schedule, or sooner if 
clinically indicated for submission to BICR. Also, if participants discontinue treatment without 
BICR confirmed radiographic progression, tumor assessments will continue according to the 
protocol specified schedule, as noted in Section 2 (Schedule of Activities) for submission to the 
BICR until progression has been confirmed by BICR. If the planned start of subsequent anticancer 
therapy is sooner than the time of next scheduled tumor assessment, every effort should be made 
to repeat tumor imaging prior to initiation of subsequent anticancer therapy unless clinically 
infeasible. 
All study treatment decisions will be based on the investigator’s assessment of tumor images and 
not on the BICR assessment. Tumor assessment by the Investigator must continue until 
Investigator-assessed distant metastases, as noted above. 
9.1.2 
Outcomes Research Assessments 
The evaluation of patient-reported outcomes is an increasingly important aspect of clinical efficacy 
in oncology trials. Such data provide an understanding of the impact of treatment from the 
participant’s perspective and offer insights into patient experience that may not be captured 
through physician reporting. Additionally, generic health-related quality of life measures provide 
data needed for calculating utility values to inform health economic models. 
Participants will be asked to complete the Functional Assessment of Cancer Therapy – Lung 
Cancer (FACT-L) Module, the Non-Small Cell Lung Cancer – Symptom Assessment 
Questionnaire (NSCLC-SAQ), 5-level version of the EuroQol Group’s EQ-5D (EQ-5D-5L) and 
the Patient Global Impression of Severity (PGI-S). 
The NSCLC-SAQ, PGI-S, FACT-L, and EQ-5D-5L will be administered via an electronic device 
during specified clinic visits, and will be completed prior to any other assessments or study 
procedures when they are being administered during study visits. In addition, the PRO measures 
will be completed at designated time points during the long-term Follow-up Period and entered 
into the CRF. If exceptional circumstances preclude the continued administration of measures 
using planned modalities, then alternate administration methods may be required, after 
consultation with Sponsor or the Sponsor’s representative. 
Section 2 (Schedule of Activities) provides information regarding the timing of PRO assessments 
during the CCRT Period, Recovery Period, Maintenance Period, and during the long-term Follow- 
up Period. 
Additional information about the timing of each assessment is described below. 
9.1.2.1 
FACT-L 
The Functional Assessment of Cancer Therapy – Lung (FACT-L) cancer module, is a widely-used, 
reliable, and valid measure of multidimensional health status among people who have lung cancer. 
The FACT-L scale is a 36-item self-report instrument that measures multidimensional QOL by 
asking participants to rate a series of statements on a 5-point Likert scale. The FACT-L, version 
4, is a combination of the 27-item FACT-General (FACT-G) and the 9-item Lung Cancer Subscale 

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(LCS). A subset of the 7 items from FACT-L (2 of the 9 items are not scored, and will not be 
administered) will be used to calculate the LCS, which will be used to assess disease-specific 
symptom severity. 
A total FACT-G score is calculated by summing the physical well-being (PWB), social/family 
well-being (SWB), emotional well-being (EWB), and functional well-being (FWB) subscale 
scores. A total FACT-L score is obtained by summing the FACT-G score with the LCS, thereby 
augmenting the FACT-G with lung cancer–specific QOL information. The FACT-L also contains 
the GP5 item from the FACT-G, which is used to assess the bother associated with the side effects 
of treatment. Each of the items is scored on a five-point scale from zero (Not at all) to four (Very 
much). Higher scores indicate greater quality of life. The FACT-L uses a recall period of “the past 
7 days.” 
The FACT-L will be administered per Section 2 (Schedule of Activities). 
9.1.2.2 
Non-Small Cell Lung Cancer Symptom Assessment Questionnaire 
(NSCLC-SAQ) 
The NSCLC-SAQ is a 7-item PRO measure intended for use in advanced NSCLC clinical trials to 
support medical product labelling.45 The NSCLC-SAQ uses a 7-day recall period and verbal rating 
scales. It was developed in accordance with the US Food and Drug Administration’s PRO 
Guidance and scientific best practices, and the resulting qualitative interview data provide 
evidence of content validity. The NSCLC-SAQ total score measures overall severity of the 
following NSCLC symptoms: cough, pain, dyspnea, fatigue, and appetite. The NSCLC-SAQ has 
been qualified for exploratory use to measure symptoms of non-small cell lung cancer in drug 
development programs. Further evaluation is needed on the instrument’s longitudinal 
measurement properties and the interpretation of clinically meaningful within-patient change in 
score. After the NSCLC-SAQ’s longitudinal measurement properties and the interpretation of 
clinically meaningful within-patient change have been evaluated, the NSCLC-SAQ total score is 
intended to support labeling claims related to change in overall symptoms of NSCLC. Data from 
this study will help to interpret the psychometric properties and threshold for clinically meaningful 
within-patient change in the NSCLC-SAQ total score within locally advanced untreated NSCLC 
participants. 
The NSCLC-SAQ will be administered per Section 2 (Schedule of Activities). 
9.1.2.3 
EQ-5D-5L 
The EQ-5D-5L46 is a standardized instrument used to measure self-reports of health status and 
functioning. The instrument’s descriptive system consists of 5 dimensions: mobility, self-care, 
usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels, reflecting 
no problems, slight problems, moderate problems, severe problems and extreme problems. A 
dimension for which there are no problems is said to be at level 1, while a dimension for which 
there are extreme problems is said to be at level 5. Thus, the vectors 11111 and 55555 represent 
the best health state and the worst health state, respectively, as described by the EQ-5D-5L. 
Altogether, the instrument describes 55 = 3,125 health states. 

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Empirically-derived weights can be applied to an individual’s responses to the EQ-5D-5L 
descriptive system to generate an index measuring the value to society of his or her current 
health. 47 Utility index values range from a 1 (full health) to 0 (dead) with negative values 
indicating a state considered worse than being dead. In addition, the EQ-5D-5L includes a visual 
analog scale (VAS) that allows respondents to rate their own current health on a 0-100 point scale 
ranging from “the worst health you can imagine” to the “best health you can imagine.” The 
EQ-5D-5L uses a recall period of “today.” 
The EQ-5D-5L will be administered per Section 2 (Schedule of Activities). 
9.1.2.4 
Patient Global Impression of Severity (PGI-S) 
PGI-S will be included as an additional exploratory endpoint. The PGI-S is a single item that 
assesses participant’s perceptions of overall severity of cancer symptoms for the last 7 days with 
response options ranging from “none” to “very severe.” Data collected via the PGI-S will be used 
as an anchor measure to assess the psychometric measurement properties and the threshold for 
meaningful change for the NSCLC-SAQ. 
The PGI-S will be administered per Section 2 (Schedule of Activities). 
9.2 
Adverse Events 
The definitions of an AE or serious adverse event (SAE) can be found in Appendix 3. 
AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the 
participant's legally acceptable representative). 
The investigator and any qualified designees are responsible for detecting, documenting, and 
reporting events that meet the definition of an AE or SAE and remain responsible for following up 
AEs that are serious, considered related to the study treatment or the study, or that caused the 
participant to discontinue before completing the study. 
Contacts for SAE reporting are specified in Appendix 3. 
9.2.1 
Time Period and Frequency for Collecting AE and SAE Information 
Collect all nonserious adverse events (not only those deemed to be treatment-related) continuously 
during the treatment period and for a minimum of 100 days following discontinuation of study 
treatment. See Section 9.2.3 for additional details on Follow-up. 
All SAEs must be collected from the time of signing the informed consent form, including those 
thought to be associated with protocol-specified procedures and within 100 days of discontinuation 
of dosing. 
All AEs (SAEs and non-serious AEs) associated with confirmed or suspected SARS-CoV-2 
infection must be collected from the time of signing the consent and within 100 days following 
discontinuation of dosing. 
The investigator must report any SAE that occurs after these time periods and that is believed to 
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• Medical occurrences that begin before the start of study treatment but after obtaining informed 
consent will be recorded on the appropriate section of the eCRF module. 
• All SAEs will be recorded and reported to Sponsor or designee within 24 hours, as indicated 
in Appendix 3. 
• The investigator will submit any updated SAE data to the sponsor or designee within 24 hours 
of updated information being available. 
 
For participants randomized to treatment and never treated with study treatment, collect SAEs for 
30 days from the date of randomization. 
Investigators are not obligated to actively seek AEs or SAEs in former study participants. 
However, if the investigator learns of any SAE, including a death, at any time after a participant 
has been discharged from the study, and he/she considers the event reasonably related to the study 
treatment or study participation, the investigator must promptly notify the sponsor. 
The method of evaluating and assessing causality of AEs and SAEs and the procedures for 
completing and reporting/transmitting SAE reports are provided in Appendix 3. 
9.2.2 
Method of Detecting AEs and SAEs 
Adverse events can be spontaneously reported or elicited during open-ended questioning, 
examination, or evaluation of a participant. Care should be taken not to introduce bias when 
collecting AE and/or SAEs. Inquiry about specific AEs should be guided by clinical judgment in 
the context of known adverse events, when appropriate for the program or protocol. 
Every AE must be assessed by the investigator with regard to whether it is considered immune- 
mediated. For events which are potentially immune-mediated, additional information will be 
collected on the participant’s case report form. 
9.2.3 
Follow-up of AEs and SAEs 
• Nonserious AEs should be followed to resolution or stabilization, or reported as SAEs if they 
become serious (see Appendix 3). 
• Follow-up is also required for nonserious AEs that cause interruption or discontinuation of 
study treatment and for those present at the end of study treatment as appropriate. 
• All identified nonserious AEs must be recorded and described on the nonserious AE page of 
the CRF (paper or electronic). Completion of supplemental CRFs may be requested for AEs 
and/or laboratory abnormalities that are reported/identified during the course of the study. 
 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, non-serious AEs of special interest (as defined in 
Section 9.2, and AEs (SAEs and non-serious AEs) associated with confirmed or suspected 
SARS-CoV-2 infection will be followed until resolution, until the condition stabilizes, until the 
event is otherwise explained, the event is deemed irreversible, or until the participant is lost to 
follow-up (as defined in Section 8.3) or for suspected cases of SARS-CoV-2, until infection is 
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Further information on follow-up procedures is given in Appendix 3. 
9.2.4 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the investigator to the Sponsor of SAEs is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a 
product under clinical investigation are met. 
• An investigator who receives an investigator safety report describing SAEs or other specific 
safety information (eg, summary or listing of SAEs) from the Sponsor will file it along with 
the Investigator’s Brochure and will notify the IRB/IEC, if appropriate according to local 
requirements. 
 
Sponsor or designee will be reporting adverse events to regulatory authorities and ethics 
committees according to local applicable laws including Regulation EU No. 536/2014 and FDA 
Code of Federal Regulations 21 CFR Parts 312 and 320. A SUSAR (Suspected, Unexpected 
Serious Adverse Reaction) is a subset of SAEs and will be reported to the appropriate regulatory 
authorities and investigators following local and global guidelines and requirements. 
9.2.5 
Pregnancy 
If, following initiation of the study treatment, it is subsequently discovered that a participant is 
pregnant or may have been pregnant at the time of study exposure, including during at least 
5 half-lives after product administration, the investigator must immediately notify the BMS 
Medical Monitor/designee of this event and complete and forward a Pregnancy Surveillance Form 
to BMS Designee within 24 hours of awareness of the event. Pregnancy reporting must follow the 
same transmission timing and processes to BMS as those used for SAEs, in accordance with 
reporting procedures described in Appendix 3. 
If the investigator determines a possible favorable benefit/risk ratio that warrants continuation of 
study treatment, or re-initiation of study treatment, a discussion between the investigator and the 
BMS Medical Monitor/designee must occur. If, for whatever reason, the pregnancy has ended, 
confirmed by negative serum pregnancy test, treatment may be resumed (at least 3 weeks and not 
greater than 6 weeks after the pregnancy has ended), following approvals of 
participant/sponsor/IRB/EC, as applicable. 
Follow-up information regarding the course of the pregnancy, including perinatal and neonatal 
outcome and, where applicable, offspring information must be reported on the Pregnancy 
Surveillance Form. 
Any pregnancy that occurs in a female partner of a male study participant should be reported to 
Sponsor or designee. In order for Sponsor or designee to collect any pregnancy surveillance 
information from the female partner, the female partner must sign an informed consent form for 
disclosure of this information. Information on this pregnancy will be collected on the Pregnancy 
Surveillance Form. 
In cases where a study treatment can be present in seminal fluid, at exposures sufficient to 
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between a male participant and a pregnant WOCBP partner(s), the information should be reported 
to the Sponsor or designee, even if the male participant has undergone a successful vasectomy. In 
order for Sponsor or designee to collect any pregnancy surveillance information from the female 
partner, the female partner(s) must sign an informed consent form for disclosure of this 
information. Information on the pregnancy will be collected on the Pregnancy Surveillance Form. 
9.2.6 
Laboratory Test Result Abnormalities 
The following laboratory test result abnormalities should be captured on the nonserious AE CRF 
page or SAE Report Form electronic, as appropriate. Paper forms are only intended as a back-up 
option when the electronic system is not functioning. 
• Any laboratory test result that is clinically significant or meets the definition of an SAE 
• Any laboratory test result abnormality that required the participant to have study treatment 
discontinued or interrupted 
• Any laboratory test result abnormality that required the participant to receive specific 
corrective therapy 
 
It is expected that wherever possible, the clinical rather than laboratory term would be used by the 
reporting investigator (eg, anemia versus low hemoglobin value). 
9.2.7 
Potential Drug Induced Liver Injury (DILI) 
Wherever possible, timely confirmation of initial liver-related laboratory abnormalities should 
occur prior to the reporting of a potential drug induced liver injury (DILI) event. All occurrences 
of potential DILIs meeting the defined criteria must be reported as SAEs (see Section 9.2 and 
Appendix 3 for reporting details). A potential DILI is defined as: 
1) Aminotransaminases (ALT or AST) elevation > 3 times upper limit of normal (ULN), 
AND 
2) Total bilirubin > 2 times ULN, without initial findings of cholestasis (elevated serum alkaline 
phosphatase), 
AND 
3) No other immediately apparent possible causes of AT elevation and hyperbilirubinemia, 
including, but not limited to, viral hepatitis, pre-existing chronic or acute liver disease, or the 
administration of other drug(s) known to be hepatotoxic. 
 
9.2.8 
Other Safety Considerations 
Any significant worsening noted during interim or final physical examinations, electrocardiogram 
(ECG), x-ray filming, any other potential safety assessment required or not required by protocol 
should also be recorded as a nonserious or serious AE, as appropriate, and reported accordingly. 

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9.2.8.1 
Immune-mediated Adverse Events 
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or 
immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor 
progression) have been ruled out. IMAEs can include events with an alternate etiology which were 
exacerbated by the induction of autoimmunity. Information supporting the assessment will be 
collected on the participant’s case report form. 
9.3 
Overdose 
An overdose is defined as the accidental or intentional administration of any dose of a product that 
is considered both excessive and medically important. Overdoses that meet the regulatory 
definition of SAE will be reported as an SAE (see Appendix 3). 
9.4 
Safety 
Planned time points for all safety assessments are listed in Section 2: Schedule of Activities. 
9.4.1 
Physical Examinations 
See Schedule of Activities. 
9.4.2 
Vital Signs 
Vital sign measurements will be recorded per Section 2 (Schedule of Activities). Vital signs include 
heart rate, systolic and diastolic blood pressure, and temperature. It is preferred that the same arm be 
used for all blood pressure readings, if possible. 
9.4.3 
Electrocardiograms 
All participants will have 12-lead electrocardiogram (ECG) done during Screening and at End of 
the Recovery Period, as specified in the Schedule of Activities (Section 2). 
9.4.4 
Clinical Safety Laboratory Assessments 
A list of the clinical laboratory analyses to be tested is provided in Table 9.4.4-1. All clinical safety 
laboratory assessments will be performed locally per the Schedule of Activities (Section 2). 
Investigators must document their review of each laboratory safety report. The Investigator or 
qualified Sub-Investigator will review all results for clinical significance. Any laboratory result 
deemed clinically significant (ie, is associated with signs and symptoms, requires treatment, or 
requires follow up) will be recorded as an AE as described in Section 9.2. 

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Table 9.4.4-1: 
Clinical Safety Laboratory Assessments 
 
Hematology -CBC 
Hemoglobin 
Hematocrit 
Total leukocyte count, including differential 
Platelet count 
Chemistry 
Aspartate aminotransferase (AST) 
Alanine aminotransferase (ALT) 
Total bilirubin 
Alkaline phosphatase (ALP) 
Lactate dehydrogenase (LDH) 
Creatinine 
Blood Urea Nitrogen (BUN) or serum urea 
Glucose 
Albumin 
Sodium 
Potassium 
Chloride 
Calcium 
Phosphorus 
CK 
TSH, free T3, and free T4 - screening 
TSH, with reflexive fT3 and fT4 if TSH is abnormal - on D1 of 
each treatment cycle (except for Arm C in the CCRT period only) 
Serology 
Hepatitis B/C, (HBV sAG, HCV antibody or HCV RNA), - screening only. Testing does not need to be repeated 
during re-enrollment if the previous testing is performed within 45 days prior to randomization. 
Testing for HIV at screening must be performed where mandated by local requirements. 
Other Analyses 
Pregnancy test (WOCBP only: minimum sensitivity 25 IU/L or equivalent units of HCG). 
Follicle stimulating hormone (FSH) screening -only required to confirm menopause in women < age 55 
Urinalysis - screening only and as clinically indicated. 
Abbreviations: ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; 
BUN, blood urea nitrogen; CBC, complete blood count; CK, creatine kinase; FSH, follicle stimulating hormone; fT3, 
free triiodothyronine; fT4, free thyroxine; HBV, hepatitis B virus; HCG, human chorionic gonadotropin; HCV, 
hepatitis C virus; HIV, human immunodeficiency virus; LDH, lactate dehydrogenase; RNA, ribonucleic acid; sAG, 
surface antigen; T3, triiodothyronine; T4, thyroxine; TSH, thyroid stimulating hormone; WOCBP, women of 
childbearing potential. 
 
9.4.5 
Imaging Safety Assessment 
Any incidental findings of potential clinical relevance that are not directly associated with the 
objectives of the protocol should be evaluated and handled by the Study Investigator as per 
standard medical/clinical judgment. 
9.5 
Pharmacokinetics 
Pharmacokinetic (PK) and immunogenicity (IMG) assessment data will be collected from study 
participants in the treatment arms receiving nivolumab and ipilimumab (Arm A and Arm B) at the 
time points indicated in Table 9.5-1, Table 9.5-2, Table 9.5-3, and Table 9.5-4. All time points are 

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relative to the start of the first study drug administration. All on-treatment time points are intended 
to align with days on which study drug is administered; if dosing occurs on a different day, the PK 
and IMG sampling should be adjusted accordingly. If it is known that a dose is going to be delayed, 
then the predose sample should be collected just prior to the delayed dose. However, if a predose 
sample is collected but the dose is subsequently delayed, an additional predose sample should not 
be collected. 
Further details of sample collection, processing, and shipment will be provided in the laboratory 
procedures manual. Serum PK samples will be analyzed for nivolumab/ipilimumab by a validated 
ligand binding assay. Additionally, selected serum PK samples may be analyzed by exploratory 
and/or research methods that measure nivolumab and/or ipilimumab; exploratory/research results 
will not be reported. 
Immunogenicity samples will be analyzed for anti-nivolumab/ipilimumab antibodies by validated 
immunogenicity assays. Samples may also be analyzed for neutralizing antibodies by a validated 
method. Serum samples may be analyzed by exploratory and/or research methods that measures 
anti-drug antibodies for technology exploration purposes; exploratory/research results will not be 
reported. Serum/plasma samples designated for PK or 
may also be used 
for immunogenicity analysis if required (eg, insufficient volume for complete immunogenicity 
assessment or to follow up on suspected immunogenicity related AE). 
Table 9.5-1: 
Pharmacokinetic and Immunogenicity Sampling in Arm A (CCRT) 
 
Study Day of 
Sample Collection 
(1 Cycle = 3 Weeks) 
Event 
Time (Relative to Nivolumab 
Infusion) 
Hour:Min 
Nivolumab PK 
Serum Sample 
Nivolumab IMG 
Serum Sample 
Cycle 1 Day 1 
Predosea 
00:00 
X 
X 
EOIb 
00:30 
X 
Cycle 2 Day 1 
Predosea 
00:00 
X 
X 
EOIb 
00:30 
X 
Cycle 3 Day 1 
Predosea 
00:00 
X 
Abbreviations: CCRT, concurrent chemoradiotherapy; Cmax, maximum concentration; EOI, end of infusion; IMG, 
immunogenicity; IV, intravenous; PK, pharmacokinetic. 
a Take all predose samples for nivolumab prior to the start of nivolumab infusion. 
b Since the end of infusion-PK (EOI-PK) sample is drawn with the intent of accurately estimating the maximum 
concentration (Cmax) of the drug, draw the EOI-PK when all the study drug has been infused. If the site infuses 
drug without a flush, then collect the EOI-PK sample within approximately 5 minutes after end of infusion. If a 
flush is administered to clear the IV lines of the drug and to ensure delivery of the entire drug dose, then draw the 
EOI-PK sample within approximately 5 minutes after end of the flush. Do not draw EOI samples from the same IV 
access that the drug was administered. 

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Table 9.5-2: 
Pharmacokinetic and Immunogenicity Sampling in Arm A 
(Maintenance) 
 
Study Day of 
Sample Collectiona 
(1 Cycle = 6 Weeks) 
Event 
Time (Relative 
to Nivolumab 
Infusion) 
Hour:Min 
Nivolumab 
PK Serum 
Sample 
Nivolumab 
IMG 
Serum 
Sample 
Ipilimumab 
PK Serum 
Sample 
Ipilimumab 
IMG Serum 
Sample 
Cycle 1 Day 1 
Predoseb 
00:00 
X 
X 
X 
X 
EOIc 
See footnote c 
X 
X 
Cycle 1 Day 22 
Predoseb 
00:00 
X 
X 
X 
X 
Cycle 2 Day 22 
Predoseb 
00:00 
X 
X 
X 
X 
Cycle 5 Day 22 
Predoseb 
00:00 
X 
X 
X 
X 
Cycle 7 Day 22 
Predoseb 
00:00 
X 
X 
X 
X 
Abbreviations: Cmax, maximum concentration; EOI, end of infusion; IMG, immunogenicity; IV, intravenous; PK, 
pharmacokinetic. 
a If ipilimumab is discontinued and nivolumab continues, ipilimumab PK and IMG should be collected only for the 
next 1 time point (corresponding to nivolumab sample collection) according to the PK table. 
b Take all predose samples for nivolumab and ipilimumab prior to the start of nivolumab infusion. 
c The EOI sample for both nivolumab and ipilimumab should be collected at the end of ipilimumab infusion. Since 
the EOI-PK sample is drawn with the intent of accurately estimating the maximum concentration (Cmax) of the 
drug, draw the EOI-PK when all the study drug has been infused. If the site infuses drug without a flush, then collect 
the EOI-PK sample within approximately 5 minutes after end of infusion. If a flush is administered to clear the IV 
lines of the drug and to ensure delivery of the entire drug dose, then draw the EOI-PK sample within approximately 
5 minutes after end of the flush. Do not draw EOI samples from the same IV access that the drug was administered. 

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Table 9.5-3: 
Pharmacokinetic and Immunogenicity Sampling in Arm B (CCRT) 
 
Study Day of 
Sample Collection 
(1 Cycle = 3 Weeks) 
Event 
Time (Relative to Nivolumab Infusion) 
Hour:Min 
Nivolumab 
PK Serum 
Sample 
Nivolumab 
IMG Serum 
Sample 
Cycle 1 Day 1 
Predosea 
00:00 
X 
X 
EOIb 
00:30 
X 
Cycle 2 Day 1 
Predosea 
00:00 
X 
X 
EOIb 
00:30 
X 
Cycle 3 Day 1 
Predosea 
00:00 
X 
Abbreviations: CCRT, concurrent chemoradiotherapy; Cmax, maximum concentration; EOI, end of infusion; IMG, 
immunogenicity; IV, intravenous; PK, pharmacokinetic. 
a Take all predose samples for nivolumab prior to the start of nivolumab infusion. 
b Since the end of infusion-PK (EOI-PK) sample is drawn with the intent of accurately estimating the maximum 
concentration (Cmax) of the drug, draw the EOI-PK when all the study drug has been infused. If the site infuses 
drug without a flush, then collect the EOI-PK sample within approximately 5 minutes after end of infusion. If a 
flush is administered to clear the IV lines of the drug and to ensure delivery of the entire drug dose, then draw the 
EOI-PK sample within approximately 5 minutes after end of the flush. Do not draw EOI samples from the same IV 
access that the drug was administered. 
 
Table 9.5-4: 
Pharmacokinetic and Immunogenicity Sampling in Arm B 
(Maintenance) 
 
Study Day of 
Sample Collection 
(1 Cycle = 4 Weeks) 
Event 
Time (Relative to Nivolumab Infusion) 
Hour:Min 
Nivolumab 
PK Serum 
Sample 
Nivolumab 
IMG Serum 
Sample 
Cycle 1 Day 1 
Predosea 
00:00 
X 
X 
EOIb 
00:30 
X 
Cycle 2 Day 1 
Predosea 
00:00 
X 
X 
Cycle 4 Day 1 
Predosea 
00:00 
X 
X 
Cycle 8 Day 1 
Predosea 
00:00 
X 
X 
Cycle 12 Day 1 
Predosea 
00:00 
X 
X 
Abbreviations: Cmax, maximum concentration; EOI, end of infusion; IMG, immunogenicity; IV, intravenous; PK, 
pharmacokinetic. 
a Take all predose samples for nivolumab prior to the start of nivolumab infusion. 
b Since the end of infusion-PK (EOI-PK) sample is drawn with the intent of accurately estimating the maximum 
concentration (Cmax) of the drug, draw the EOI-PK when all the study drug has been infused. If the site infuses 
drug without a flush, then collect the EOI-PK sample within approximately 5 minutes after end of infusion. If a 
flush is administered to clear the IV lines of the drug and to ensure delivery of the entire drug dose, then draw the 
EOI-PK sample within approximately 5 minutes after end of the flush. Do not draw EOI samples from the same IV 
access that the drug was administered. 

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Tumor tissue will be 
collected at 
 
9.6 
Pharmacodynamics 
See Section 9.8. 
9.7 
Pharmacogenomics 
See Section 9.8. 
9.8 
Biomarkers 
 

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Table 9.8-1: 
Biomarker Collection Schedule for CCRT Period for All Arms 
Study Day of Sample 
Collection 
(1 Cycle = 3 Weeks) 
Screening 
Cycle 1 Day 1 
Cycle 2 Day 1 
Cycle 3 Day 1 
Upon Progression 
Tumor 
(Archival or 
Fresh biopsy 
in FFPE) 
X 
Abbreviations: CCRT, concurrent chemoradiotherapy; 
. 

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9.8.1 
Tumor Tissue Specimens 
Archival (or fresh) FFPE tumor tissue is to be collected within 3 months prior to enrollment with 
no intervening systemic anti-cancer treatment between time of acquisition and randomization. A 
sample block or 5 to 10 unstained slides must be submitted to the central laboratory. In order for 
the participant to be treated, the sample must meet the minimum quality requirements, as 
determined by the central laboratory during the Screening Period. 
 
Tumor samples must be a core biopsy, excisional biopsy, or surgical specimen. Biopsy of 
pathological lymph nodes can be submitted. Fine needle aspirates/biopsy or other cytology 
specimens are insufficient for enrollment. Target lesion should not be biopsies unless there are no 
other lesions suitable for biopsy. If a target lesion is used for biopsy, the lesion must be > 2 cm in 
the longest diameter. 

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9.9 
Medical Resource Utilization and Health Economics 
Health care resource utilization data will be collected for all randomized participants using an 
internal eCRF developed for use in previous trials. The form, which is completed by study staff, 
records information about hospital admissions, including number of days spent in various wards 
and discharge diagnosis, as well as non-protocol specified visits related to study therapy, including 
date of visit, reason for visit, and type of visit. The health care resource utilization data will be 
used to support subsequent economic evaluations. 

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10 
STATISTICAL CONSIDERATIONS 
10.1 
Sample Size Determination 
The sample size is determined based on the primary endpoint of PFS between Arm A and Arm C. 
A total of 888 participants are planned to be randomized across the 3 treatment groups in a 1:1:1 
ratio. 
If the PFS comparison between Arm A and Arm C is statistically significant, then 0.05 alpha will 
be passed to the OS comparison between Arm A vs Arm C, followed by OS comparison between 
Arm B vs Arm C. All tests will be 2-sided. Figure 10.1-1 graphically presents the planned testing 
procedure. 
Figure 10.1-1: 
Testing Procedure for Primary and Key Secondary Endpoints 
 
Abbreviations: OS, overall survival; PFS, progression-free survival. 
Note: Arms A, B, and C are described in Section 5.1. 
 
UPDATE: Due to the Ukraine-Russia conflict, the Sponsor made the decision to discontinue 
clinical trials in Russia by the end of June 2022 as a result of increased logistical challenges of 
ensuring continuity of care for study participants. The study team performed an assessment of data 
quality and concluded that data collected among Russian participants (30 randomized) appeared 
adequate for inclusion in the primary analysis, though many participants would not be able to 
receive the full course of their randomized intervention and would have short follow-up. A 
sensitivity analysis for exclusion of all Russian participants is planned. Consequentially, 
enrollment was permitted to continue slightly beyond the original target of 888 randomized 
participants to account for potential data and statistical power loss in Russian sites and, ultimately, 
925 participants were randomized. 

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formal PFS interim analyses are planned at 
planned PFS events as described in Table 10.1.1-1. 
of total 
The stopping boundaries for the above PFS interim and final analyses 
10.1.1 
Sample Size Justification for PFS 
Based on the 4-year update from the PACIFIC trial and the PROCLAIM PFS curve,3,10 a non- 
constant PFS hazard was observed. For the sample size calculation for PFS per BICR between 
Arm A and Arm C, a piecewise exponential distribution with a 3-month delay period was assumed. 
 
A total of 
 (ie, progression events or deaths) in Arms A and C will provide 
approximately 82% power considering the above PFS assumptions with 0.05 2-sided alpha. Two 
will be based on the actual number of PFS events at the time of the analysis using Lan-DeMets 
alpha spending function with O’Brien-Fleming boundaries. 
 
 
 
 
However, the PFS analyses are driven by the required 
number of events, and the actual analysis time will depend on actual enrollment speed and events 
accrual and may be different from projections. 

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Table 10.1.1-1: 
 
Primary Endpoint 
PFS 
Comparison 
Arm A vs Arm C 
Sample size (Arm A and Arm C) 
592 
Overall Alpha 
0.05 
Overall Power 
~82% 
 
 
Table 10.1.1-2: 
 
Primary Endpoint 
PFS 
Comparison 
Arm A vs Arm C 
Sample size (Arm A and Arm C) 
592 
Overall Alpha 
0.05 
Overall Power 
~82% 
Summary of Sample Size Parameters 
Summary of Sample Size Parameters 

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Table 10.1.1-2: 
 
Primary Endpoint 
PFS 
 
 
 
 
 
 
 
 
 
 
 
10.1.2 
Sample Size Justification for OS 
 
 
 
respectively, to detect above OS assumption. 
will provide approximately 80% power, 
 
. OS will only be 
formally tested if PFS is significant. If PFS is significant but a significant OS benefit is not 
observed, then subsequent OS analyses will be triggered by accumulating OS events as described 
in Table 10.1.2-1. The stopping boundaries at the interim and final analyses will be based on the 
actual number of OS events at the time of the analysis using a separate Lan-DeMets alpha spending 
function with O’Brien-Fleming boundaries. 
 
However, the timing of the OS final analysis is based on OS 
events accrual rate from an exponential distribution. Assuming a lower events rate towards the end 
of the curve, the final analysis may occur later. 
 
Summary of Sample Size Parameters 

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Table 10.1.2-1: 
Summary of Sample Size Parameters and Projected Schedule of 
Analyses for OS 
 
Key Secondary Endpoint 
OSa 
Comparison 
Arm A vs Arm C 
Sample size (Arm A and Arm C) 
592 
Overall Power 
~80% 
Abbreviations: 
OS, overall survival; PFS, progression-free survival. 
a OS will be tested only if PFS is significant. 

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Table 10.1.2-2: 
Summary of Sample Size Parameters and Projected Schedule of 
Analyses for OS 
 
Key Secondary Endpoint 
OSa 
Comparison 
Arm A vs Arm C 
Sample size (Arm A and Arm C) 
592 
Overall Power 
~80% 
Abbreviations: 
; OS, overall survival; PFS, progression-free survival. 
a OS will be tested only if PFS is significant. 

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10.2 
Populations for Analyses 
For purposes of analysis, the following populations are defined: 
 
Population 
Description 
All Enrolled Participants 
All participants who sign an informed consent form and are registered into the 
IRT 
ITT Population / All 
Randomized Participants 
All enrolled participants who are randomized to any treatment arm in the 
study. This is the primary population for efficacy and baseline characteristics 
Safety Population / All Treated 
Participants 
All enrolled participants who received at least one dose of study treatment. 
This is the primary population for overall dosing and safety 
Maintenance Therapy Treated 
Participants 
All participants who completed CCRT period and received at least one dose in 
the maintenance period. This is primary population for maintenance dosing 
and safety 
PK and immunogenicity 
participants 
All treated participants with available serum time-concentration data and 
immunogenicity samples from randomized participants dosed with nivolumab 
and/or ipilimumab. 
Abbreviations: CCRT, concurrent chemoradiotherapy; IRT, Interactive Response Technology; ITT, intent-to-treat; 
PK, pharmacokinetic. 
 
10.3 
Statistical Analyses 
In general, continuous data will be summarized by descriptive statistics, including number of 
participants, mean, standard deviation, median, minimum, and maximum. Categorical data will be 
summarized by the number and percentage of participants. Unless otherwise specified, data will 
be summarized by treatment arm. 
No formal testing for PFS between Arm B vs Arm C nor PFS/OS for Arm A vs Arm B will be 
performed. These evaluations will be performed descriptively, as outlined in the statistical analysis 
plan. 
A detailed description of analysis methods will be provided in the statistical analysis plan (SAP). 
The statistical analysis plan will be developed and finalized before the first efficacy interim 
database lock. The SAP will describe the selection of participants to be included in the analyses, 
and procedures for accounting for missing, unused, and spurious data. Below is a summary of 
planned statistical analyses of the primary and secondary endpoints. 

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10.3.1 
Efficacy Analyses 
 
Endpoint 
Statistical Analysis Methods 
Primary analyses 
Progression- 
free Survival 
(per BICR) 
A vs C 
Progression-free survival (PFS) is defined as the time between the date of randomization and 
the first date of documented progression per RECIST 1.1, as determined by BICR, or death 
due to any cause, whichever occurs first, regardless of receipt of subsequent anti-cancer 
therapy prior to the documented progression as confirmed by BICR. Participants who die 
without a reported progression will be considered to have progressed on the date of their death. 
Participants who did not progress or die will be censored on the date of their last evaluable 
tumor assessment. Participants who did not have any on study tumor assessments and did not 
die will be censored on their date of randomization. First on-study scans are expected only 
after completion of CCRT (ie, last dose of radiotherapy) during approximately the Week 3 
Recovery Period check. Following that, tumor assessments are scheduled to be performed at 
week 24 (±7 days) from the date of randomization, then every 12 weeks (±7 days) for 36 
months (from date of randomization), then every 24 weeks (±7 days) after 36 months from 
randomization. Tumor assessments will be submitted to BICR until BICR-confirmed disease 
progression. 
A log-rank test stratified by 3 stratification factors (age, PD-L1 status, and stage) will be used 
to compare PFS between Arm A and Arm C at 0.05 level. A Cox proportional hazards model 
with treatment as the single covariate, stratified by the above stratification factors, will be used 
to estimate the hazard ratio and corresponding 95% CI. The Kaplan-Meier method will be used 
to further summarize PFS, including PFS curves, medians with corresponding 95% CIs. The 
PFS rates at 6, 12, 18, 24, etc months will also be estimated depending on minimum follow-up 
duration. 
Secondary/Exploratory analyses 
Overall 
Survival 
A vs C 
Overall survival (OS) is defined as the time between the date of randomization and the date of 
death due to any cause. OS will be censored on the last date a participant was known to be 
alive. OS will be followed continuously while participants are on the study treatment and 
every 3 months via in-person or phone contact after participants discontinue the study 
treatment. 
B vs C 
OS will be analyzed using similar method as PFS. 
A vs B 
OS in A vs C, B vs C will be tested following the hypothesis testing procedure described in 
Section 10.1. No hypothesis testing will be performed for A vs B. 
Progression- 
free Survival 
(per BICR) 
See definition and methods of PFS in primary statistical analysis methods above. No 
hypothesis testing will be performed. 
B vs C 
A vs B 

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Endpoint 
Statistical Analysis Methods 
Objective 
Response Rate 
(ORR) per 
BICR 
A vs C 
B vs C 
A vs B 
Objective Response Rate (ORR) is defined as the number of participants with a confirmed 
BOR of CR or PR divided by the number of randomized participants for each treatment group. 
BOR is defined as the best response designation, recorded between the date of randomization 
and the date of objectively documented progression per RECIST 1.1 as determined by BICR 
or the date of initiation of local therapy or the date of subsequent anticancer therapy, 
whichever occurs first. For participants without documented progression or local therapy or 
subsequent anticancer therapy, all available response designations will contribute to the BOR 
determination. For participants who continue study medication beyond progression, the BOR 
should be determined based on response designations recorded at the time of the initial 
RECIST 1.1 defined progression. 
An odds ratio and 95% confidence interval (CI) will be calculated using a Cochran-Mantel 
Haenszel (CMH) methodology stratified by the 3 stratification factors (age, PD-L1 status, and 
stage). The ORR difference between the 2 treatment arms with its 95% CI will be reported. 
The ORR and its corresponding 95% exact CI will also be calculated by Clopper-Pearson 
method for each randomized arm. 
Time to 
Response and 
Duration of 
Response (per 
BICR) 
Time to response (TTR) is defined as the time, in months, from randomization to the first 
objective documentation of PR or better assessed per BICR. Time to response is restricted to 
the population of participants who achieved a best response of PR or better assessed per BICR. 
Duration of objective response (DoR) is defined as the time between the date of first 
confirmed response to the date of the first documented tumor progression (per RECIST 1.1) 
per BICR assessment, or death due to any cause, whichever occurs first. Participants who 
neither progress nor die will be censored on the date of their last evaluable tumor assessment. 
Participants who started any subsequent anticancer therapy without a prior reported 
progression will be censored at the last evaluable tumor assessment prior to or on the date of 
initiation of the subsequent anticancer therapy. DoR will be evaluated for responders (ie, 
participants with confirmed CR or PR) only as assessed by BICR. 
The Kaplan-Meier method will be used to further summarize DOR, including DOR curves, 
medians with corresponding 95% CIs. 
PFS, ORR, 
DoR, TTR per 
Investigator 
assessment of 
tumor imaging 
See definition of endpoints above. Per Investigator assessment of tumor imaging according to 
RECIST 1.1. 
ORR, PFS, DOR, TTR assessed by investigator per RECIST 1.1 will be analyzed similarly to 
these endpoints assessed by BICR. No hypothesis testing will be performed. 
Time to death 
or distant 
metastases 
(TTDM) 
TTDM is defined as the time from the date of randomization until the first date of distant 
metastasis or death in the absence of distant metastasis. Distant metastasis is defined as any 
new lesion that is outside of the thorax (except for heart) according to RECIST 1.1, as assessed 
by the Investigator. Participants who have not developed distant metastasis or died at the time 
of analysis will be censored at the time of the latest date of assessment from their last 
RECIST 1.1 assessment. However, if the participant has distant metastasis or dies after 2 or 
more missed visits, the participant will be censored at the time of the latest RECIST 1.1 
assessment prior to the 2 missed visits. If the participant has no visits or does not have baseline 
data they will be censored at Day 1 unless they die within 2 visits of baseline. 
TTDM will be analyzed similarly as primary time-to-event endpoints as PFS, OS. No 
hypothesis testing will be performed. 
PFS on Next 
Line Therapy 
(PFS-2) 
PFS on next-line therapy (PFS-2) is defined as the time from randomization to objectively 
documented progression, per investigator assessment, after the next line of therapy or to death 
from any cause, whichever occurs first. Participants who were alive and without progression 
after the next line of therapy will be censored at last known alive date. 
PFS-2 will be analyzed similarly as primary time-to-event endpoints as PFS, OS. No 
hypothesis testing will be performed. 

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Endpoint 
Statistical Analysis Methods 
Patient-reported 
outcomes 
Proportion without meaningful deterioration in symptoms: The proportion of participants with 
no meaningful deterioration in a disease-related symptom score (NSCLC-SAQ Total Score) by 
48 weeks following initiation of maintenance treatment. A detailed description of analysis 
methods and the threshold for meaningful change will be provided in the statistical analysis 
plan (SAP). 
Abbreviations: BICR, blinded independent central review; BOR, best overall response; CCRT, concurrent 
chemoradiotherapy; CI, confidence interval; CMH, Cochran-Mantel Haenszel; CR, complete response; DoR, duration 
of response; NSCLC-SAQ, Non-small Cell Lung Cancer Symptom Assessment Questionnaire; ORR, objective 
response rate; OS, overall survival; PD-L1, programmed death-ligand 1; PFS, progression-free survival; 
PFS-2, progression-free survival on next line therapy; PR, partial response; RECIST 1.1, Response Evaluation Criteria 
in Solid Tumors version 1.1; SAP, statistical analysis plan; TTDM, time to death or distant metastases; TTR, time to 
response. 
 
10.3.2 
Safety Analyses 
All safety analyses will be performed on all treated participants. 
 
Endpoint 
Statistical Analysis Methods 
Primary 
Not applicable 
Secondary 
Safety 
Safety analysis will be performed in all treated participants. Descriptive statistics of safety will be 
presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse 
Events (CTCAE) version 4.0 by treatment group. All on-study AEs, drug-related AEs, SAEs and 
drug-related SAEs will be tabulated using worst grade per NCI CTCAE v 4.0 criteria by system 
organ class and preferred term. On-study lab parameters including hematology, chemistry, liver 
function and renal function will be summarized using worst grade per NCI CTCAE v 4.0 criteria. 
Frequency, management and resolution of IMAEs will be analyzed. A tabular summary and 
comparative analysis between treatment arms of the incidence of overall IMAEs (by preferred 
term) and serious IMAEs will be performed. A descriptive analysis of IMAEs including time-to- 
onset, severity, duration, action taken with the study treatment, dosing delays of the study 
treatment, corticosteroid details, re-challenge information and outcome of the AE are individually 
characterized: 
• 
pneumonitis IMAEs 
• 
diarrhea/colitis IMAEs 
• 
hepatitis IMAEs 
• 
nephritis and renal dysfunction IMAEs 
• 
rash IMAEs 
• 
endocrine IMAEs by subcategories including adrenal insufficiency, hypophysitis, 
hypothyroidism/thyroiditis, hyperthyroidism, and diabetes 
Exploratory 
Will be described in the statistical analysis plan finalized before the first efficacy interim database 
lock. 
Abbreviations: AE, adverse event; CTCAE v 4.0, Common Terminology Criteria for Adverse Events version 4.0; 
IMAE, immune-mediated adverse event; NCI, National Cancer Institute; SAE, serious adverse event. 
 
10.3.3 
Other Analyses 
Additional information will be described in the statistical analysis plan. 

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In addition to
Exploratory analyses for PK, IMG, healthcare resource utilization, PROs, and 
 will be 
described in the statistical analysis plan which will be finalized before the first efficacy interim 
database lock. The population pharmacokinetics analysis and pharmacodynamic analyses will be 
presented separately from the main clinical study report. 
Additional psychometric analyses on the PRO measures will be described in a separate stand-alone 
PRO analysis plan. 
10.3.4 
Interim Analyses 
Formal efficacy interim analyses for PFS and OS are planned for this study. An independent 
statistician external to BMS will perform these interim and final analyses. Table 10.3.4-1 gives an 
overview of schedule and timing. 
Table 10.3.4-1: 
Interim Analyses Schedule 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
the formal planned efficacy interim analyses, the DMC will have access to periodic unblinded 
interim reports of efficacy and safety to allow a risk/benefit assessment during periodic safety 
reviews. However, no formal test will be performed and the study will not be stopped for the 
superiority during safety reviews. Additional details will be included in the DMC charter. 
The Statistical Analysis Plan will further describe the planned interim analyses. 

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ligands in regulating autoimmunity and infection. Nat Immunol. 2007;8(3):239-45. 
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21 Brahmer J, Reckamp KL, Baas P, et al. Nivolumab versus Docetaxel in Advanced Squamous 
Cell Non-small Cell Lung Cancer. N Engl J Med. 2015;373:123-35. 
22 Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab versus Docetaxel in Advanced 
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24 Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus Ipilimumab in Lung Cancer 
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27 Peters S, Felip E, Dafni U, et al. Safety evaluation of nivolumab added concurrently to 
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28 Peters S, Felip E, Dafni U, et al. Efficacy evaluation of concurrent nivolumab addition to a 
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Ann Oncol. 2019 Oct; 30 supplement 5. 
29 Jabbour SK, Lee KH, Frost N, et al. Phase II study of pembrolizumab (pembro) plus platinum 
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30 Shaverdian N, Lisberg AE, Bornazyan K et al. Previous radiotherapy and the clinical activity 
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31 Demaria S, Fomenti SC. Radiation as an immunological adjuvant: current evidence on dose 
and fractionation. Front Oncol. 2012;2:153. 
32 Formenti SC, Demaria S. Radiation therapy to convert the tumor into an in situ vaccine. Int J 
Radiat Oncol Biol Phys. 2012;84:879-80. 
33 Takamori S, Toyokawa G, Takada K et al. Combination therapy of radiotherapy and 
anti-PD-1/PD-L1 treatment in non-small-cell lung cancer: a min-review. Clin Lung Cancer 
2018;19:12-16. 
34 Zhang P, Su DM, Liang M, Fu J. Chemopreventive agents induce programmed death-1-ligand 
1 (PD L1) surface expression in breast cancer cells and promote PD-L1-mediated T cell 
apoptosis. Mol Immunol 2008;45:1470-6. 
35  Mile RH. Whole body irradiation; radiobiology or medicine? Br J Radiol 1953;26:234-41. 
36 Golden EB, Demaria S, Schiff PB et al. An abscopal response to radiation and ipilimumab in 
a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013;1:365-72. 
37 Postow MA, Callahan MK, Barker CA, et al. Immunologic correlates of the abscopal effect in 
a patient with melanoma. J Engl J Med. 201;366: 925-31. 
38 Formenti SC, Rudgvist NP, Golden E, et al. Radiotherapy induces responses of lung cancer to 
CTLA-4 blockade. Nat Med 2018;24:1845-51. 
39 Bezjak A, Temin S, Franklin G, et al. Definitive and adjuvant radiotherapy in locally advanced 
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40 Eberhardt WEE, De Ruysscher D, Weder W, et al. 2nd ESMO consensus conference in lung 
cancer: locally advanced stage III non-small-cell lung cancer. Ann Oncol.2015;26:1573-88. 
41 Hanna N, Neubauer M, Yiannoutsos C, et al. Phase III study of cisplatin, etoposide, and 
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42 OPDIVO (nivolumab) US Prescribing Information. Bristol-Myers Squibb, Princeton, NJ. 
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44 American Joint Committee on Cancer/American Joint Committee on Cancer (AJCC/UICC) 
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46 Herdman M, Gudex C, Lloyd A, et al. Development and preliminary testing of the new five- 
level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011 Dec;20(10):1727-1736. 
47 van Hout B, Janssen MF, Feng YS, et al. Interim scoring for the EQ-5D-5L: mapping the EQ- 
5D-5L to EQ-5D-3L value sets. Value in Health. 2012 Jul-Aug;15(5):708-15. 

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12 
APPENDICES 

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APPENDIX 1 
ABBREVIATIONS AND TRADEMARKS 
 
Term 
Definition 
3DRT 
3-dimensional radiotherapy 
ADA 
anti-drug antibody 
AE 
adverse event 
AIDS 
acquired immunodeficiency syndrome 
AJCC 
American Joint Committee on Cancer 
ALK 
anaplastic lymphoma kinase 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
APC 
antigen-presenting cell 
 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
ASTRO 
American Society for Radiation Oncology 
AUC 
area under the concentration-time curve 
Bcl-xL 
B-cell lymphoma-extra large 
BICR 
blinded independent central review 
BID, bid 
bis in die, twice daily 
BMS 
Bristol-Myers Squibb 
BOR 
best overall response 
BP 
blood pressure 
BTLA 
B and T lymphocyte attenuator 
BUN 
blood urea nitrogen 
C 
cycle 
Cavg28 
average serum concentration at Day 28 
CBC 
complete blood count 
CCRT 
concurrent chemoradiotherapy 
CD8 
cluster of differentiation 8 
CFR 
Code of Federal Regulations 

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Term 
Definition 
CI 
confidence interval 
CK 
creatine kinase 
cm 
centimeter 
Cmax 
maximum concentration 
CMH 
Cochran-Mantel Haenszel 
CMV 
cytomegalovirus 
CONSORT 
Consolidated Standards of Reporting Trials 
COVID-19 
coronavirus disease 2019 
CR 
complete response 
CrCl 
creatinine clearance 
CRF 
case report form, paper or electronic 
CT 
computed tomography 
CTCAE v 4.0 
Common Terminology Criteria for Adverse Events version 4.0 
CTLA-4 
cytotoxic T-lymphocyte-associated protein 4 
D 
day 
DBL 
database lock 
DILI 
drug induced liver injury 
dL 
deciliter 
DLCO 
diffusing capacity of the lungs for carbon monoxide 
DLT 
dose-limiting toxicity 
DMC 
data monitoring committee 
DNA 
deoxyribonucleic acid 
DoR 
duration of response 
EBUS 
endobronchial ultrasound 
EC50 
half maximal effective concentration 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
eg 
exempli gratia (for example) 

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Term 
Definition 
EGFR 
epidermal growth factor receptor 
EOI 
end of infusion 
EQ-5D-5L 
5-level version of the EuroQol Group’s EQ-5D 
E-R 
exposure-response 
ESMO 
European Society for Medical Oncology 
EWB 
emotional well-being 
FACT-G 
Functional Assessment of Cancer Therapy - General 
FACT-L 
Functional Assessment of Cancer Therapy – Lung Cancer 
FEV1 
forced expiratory volume during first second of forced breath 
FFPE 
formalin-fixed paraffin-embedded 
FSH 
follicle stimulating hormone 
fT3 
free triiodothyronine 
fT4 
free thyroxine 
FWB 
functional well-being 
g 
gram 
G-CSF 
granulocyte colony stimulating factors 
GFR 
glomerular filtration rate 
GTV 
gross tumor volume 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCG 
human chorionic gonadotropin 
HCRU 
healthcare resource utilization 
HCV 
hepatitis C virus 
HIV 
human immunodeficiency virus 
HR 
hazard ratio 
IB 
investigator Brochure 
IC50 
half maximal inhibitory concentration 
ICE 
intercurrent event 
ICF 
informed consent form 

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Term 
Definition 
ICOS 
inducible co-stimulator 
ie 
id est (that is) 
IEC 
independent ethics committee 
IFN-γ 
interferon gamma 
Ig 
immunoglobulin 
IHC 
immunohistochemical 
IL 
interleukin 
IM 
intramuscular 
IMAE 
immune-mediated adverse event 
IMG 
immunogenicity 
IMP 
investigational medicinal products 
IMRT 
intensity modulated radiotherapy 
IO 
immuno-oncology 
IP 
investigational product 
IRB 
institutional review board 
IRT 
interactive response technology 
ITT 
intent-to-treat 
IU 
international unit 
IV 
intravenous 
kg 
kilogram 
L 
liter 
LA 
locally advanced 
LAR 
legally acceptable representative 
LCS 
lung cancer subscale 
LDH 
lactate dehydrogenase 
LFT 
liver function test 
mAB 
monoclonal antibody 
mg 
milligram 
min 
minute 

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Term 
Definition 
mL 
milliliter 
mmHg 
millimeters of mercury 
MLR 
mixed lymphocyte reaction 
MMR 
measles, mumps, rubella 
MRI 
magnetic resonance imaging 
MTD 
maximum tolerated dose 
μg 
microgram 
N 
number of participants or observations 
N/A 
not applicable 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NSCLC 
non-small cell lung cancer 
NSCLC-SAQ 
Non-small Cell Lung Cancer Symptom Assessment Questionnaire 
OR 
odds ratio 
ORR 
objective response rate 
OS 
overall survival 
PBMC 
peripheral blood mononuclear cells 
PCR 
polymerase chain reaction 
PD 
progressive disease 
PD-1 
programmed cell death protein 
PD-L1 
programmed death-ligand 1 
PD-L2 
programmed death-ligand 2 
PE 
physical exam 
PET 
positron emission tomography 
PFS 
progression-free survival 
PFS-2 
progression-free survival on next line therapy 
PGI-S 
Patient Global Impression of Severity 
PK 
pharmacokinetics 
PPK 
population pharmacokinetic 
PR 
partial response 

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Term 
Definition 
PRO 
patient-reported outcome 
Q12W 
every 12 weeks 
Q2W 
every 2 weeks 
Q3W 
every 3 weeks 
Q4W 
every 4 weeks 
Q6W 
every 6 weeks 
QA 
quality assurance 
QC 
quality control 
R&D 
Research and Development 
RCC 
renal cell carcinoma 
RECIST 1.1 
Response Evaluation Criteria in Solid Tumors version 1.1 
RNA 
ribonucleic acid 
RT 
reverse transcription 
SAE 
serious adverse event 
sAG 
surface antigen 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SD 
standard deviation 
SmPC 
Summary of Product Characteristics 
SUSAR 
suspected, unexpected serious adverse reaction 
SWB 
social/family well-being 
T3 
triiodothyronine 
T4 
thyroxine 
TBP 
treatment beyond progression 
TCR 
T cell receptor 
TMB 
tumor mutational burden 
TNM 
tumor nodal metastasis 
TSH 
thyroid stimulating hormone 
TTDM 
time to death or distant metastasis 
TTR 
time to response 

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Term 
Definition 
ULN 
upper limit of normal 
US 
United States 
VAS 
visual analog scale 
VMAT 
volumetric modulated arc therapy 
vs 
versus 
WBC 
white blood cell 
WOCBP 
women of childbearing potential 

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APPENDIX 2 
STUDY GOVERNANCE CONSIDERATIONS 
The term ‘Participant’ is used in the protocol to refer to a person who has consented to participate 
in the clinical research study. The term ‘Subject’ used in the eCRF is intended to refer to a person 
(Participant) who has consented to participate in the clinical research study. 
REGULATORY AND ETHICAL CONSIDERATIONS 
GOOD CLINICAL PRACTICE 
This study will be conducted in accordance with: 
• Consensus ethical principles derived from international guidelines including the Declaration 
of Helsinki and Council for International Organizations of Medical Sciences (CIOMS) 
International Ethical Guidelines Good Clinical Practice (GCP), 
• as defined by the International Council on Harmonisation (ICH) 
• in accordance with the ethical principles underlying Regulation EU No. 536/2014 
• United States Code of Federal Regulations, Title 21, Part 50 (21CFR50) 
• applicable local requirements. 
 
The study will be conducted in compliance with the protocol. The protocol and any amendments 
and the participant informed consent will receive approval/favorable opinion by Institutional 
Review Board/Independent Ethics Committee (IRB/IEC), and regulatory authorities according to 
applicable local regulations prior to initiation of the study. 
All potential serious breaches must be reported to Sponsor or designee immediately. A serious 
breach is a breach of the conditions and principles of Good Clinical Practice (GCP) (occurring in 
any country) in connection with that trial or the protocol related to the trial which is likely to affect 
to a significant degree the safety or physical or mental integrity of 1 or more participants of the 
trial or the scientific value of the trial. 
Personnel involved in conducting this study will be qualified by education, training, and 
experience to perform their respective tasks. 
This study will not use the services of study personnel where sanctions have been invoked or where 
there has been scientific misconduct or fraud (eg, loss of medical licensure, debarment). 
INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE 
Before study initiation, the investigator must have written and dated approval/favorable opinion 
from the IRB/IEC for the protocol, consent form, participant recruitment materials 
(eg, advertisements), and any other written information to be provided to participants. 
The investigator or BMS should also provide the IRB/IEC with a copy of the Investigator Brochure 
or product labeling information to be provided to participants and any updates. 
The investigator, Sponsor or designee should provide the IRB/IEC with reports, updates and other 
information (eg, expedited safety reports, amendments, and administrative letters) according to 
regulatory requirements or institution procedures. 

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COMPLIANCE WITH THE PROTOCOL AND PROTOCOL REVISIONS 
The investigator should not implement any deviation or change to the protocol without prior 
review and documented approval/favorable opinion of an amendment from the IRB/IEC (and if 
applicable, also by local health authority) except where necessary to eliminate an immediate 
hazard(s) to study participants. 
If a deviation or change to a protocol is implemented to eliminate an immediate hazard(s) prior to 
obtaining relevant approval/favorable opinion(s) the deviation or change will be submitted, as soon 
as possible to: 
• IRB/IEC 
• Regulatory Authority(ies), if applicable by local regulations (per national requirements) 
 
Documentation of approval/favorable opinion signed by the chairperson or designee of the 
IRB(s)/IEC(s) and if applicable, also by local health authority must be sent to BMS. 
If an amendment substantially alters the study design or increases the potential risk to the 
participant: (1) the consent form must be revised and submitted to the IRB(s)/IEC(s) for review 
and approval/favorable opinion; (2) the revised form must be used to obtain consent from 
participants currently enrolled in the study if they are affected by the amendment; and (3) the new 
form must be used to obtain consent from new participants prior to enrollment. 
If the revision is done via an administrative letter, investigators must inform their IRB(s)/IEC(s). 
FINANCIAL DISCLOSURE 
Investigators and sub-Investigators will provide the Sponsor with sufficient, accurate financial 
information in accordance with local regulations to allow the Sponsor to submit complete and 
accurate financial certification or disclosure statements to the appropriate health authorities. 
Investigators are responsible for providing information on financial interests during the course of 
the study and for 1 year after completion of the study. 
INFORMED CONSENT PROCESS 
Investigators must ensure that participants are clearly and fully informed about the purpose, 
potential risks, and other critical issues regarding clinical studies in which they volunteer to 
participate. 
In situations where consent cannot be given by participants, their legally acceptable representatives 
(as per country guidelines) are clearly and fully informed about the purpose, potential risks, and 
other critical issues regarding clinical studies in which the participant volunteers to participate. 
The Sponsor or designee will provide the investigator with an appropriate (ie, Global or Local) 
sample informed consent form which will include all elements required by ICH, GCP and 
applicable regulatory requirements. The sample informed consent form will adhere to the ethical 
principles that have their origin in the Declaration of Helsinki. 

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Investigators must: 
• Provide a copy of the consent form and written information about the study in the language in 
which the participant is most proficient prior to clinical study participation. The language must 
be non-technical and easily understood. 
• Allow time necessary for participant or participant's legally acceptable representative to 
inquire about the details of the study. 
• Obtain an informed consent signed and personally dated by the participant or the participant's 
legally acceptable representative and by the person who conducted the informed consent 
discussion. 
• Obtain the IRB/IEC’s written approval/favorable opinion of the written informed consent form 
and any other information to be provided to the participants, prior to the beginning of the study, 
and after any revisions are completed for new information. 
 
If informed consent is initially given by a participant’s legally acceptable representative or legal 
guardian, and the participant subsequently becomes capable of making and communicating his or 
her informed consent during the study, consent must additionally be obtained from the participant. 
Revise the informed consent whenever important new information becomes available that is 
relevant to the participant's consent. The investigator, or a person designated by the investigator, 
should fully inform the participant or the participant's legally acceptable representative or legal 
guardian, of all pertinent aspects of the study and of any new information relevant to the 
participant's willingness to continue participation in the study. This communication should be 
documented. 
The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules applicable to regulatory requirements, the participant’s signed 
ICF and, in the US, the participant’s signed HIPAA Authorization. 
The consent form must also include a statement that BMS and regulatory authorities have direct 
access to participant records. 
Participants unable to give their written consent (e.g., stroke or participants with or severe 
dementia) may only be enrolled in the study with the consent of a legally acceptable representative. 
The participant must also be informed about the nature of the study to the extent compatible with 
his or her understanding, and should this participant become capable, he or she should personally 
sign and date the consent form as soon as possible. The explicit wish of a participant who is unable 
to give his or her written consent, but who is capable of forming an opinion and assessing 
information to refuse participation in, or to be withdrawn from, the clinical study at any time should 
be considered by the investigator. 
The rights, safety, and well-being of the study participants are the most important considerations 
and should prevail over interests of science and society. 

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BMS COMMITMENT TO DIVERSITY IN CLINICAL TRIALS 
The mission of BMS is to transform patients’ lives through science by discovering, developing, 
and delivering innovative medicines that help them prevail over serious diseases. 
BMS is committed to doing its part to ensure that patients have a fair and just opportunity to 
achieve optimal health outcomes. 
BMS is working to improve the recruitment of a diverse participant population with the goal that 
the clinical trial becomes more reflective of the real-world population and the people impacted by 
the diseases studied. 
DATA PROTECTION, DATA PRIVACY, AND DATA SECURITY 
BMS collects and processes personal data of study participants, patients, health care providers, 
and researchers for biopharmaceutical research and development to advance innovative, high- 
quality medicines that address the medical needs of patients. BMS ensures the privacy, protection, 
and confidentiality of such personal data to comply with applicable laws. To achieve these goals, 
BMS has internal policies that indicate measures and controls for processing personal data. BMS 
adheres to these standards to ensure that collection and processing of personal data are limited and 
proportionate to the purpose for which BMS collects such personal data. This purpose is clearly 
and unambiguously notified to the individual at the time of collection of personal data. In the true 
spirit of science, BMS is dedicated to sharing clinical trial information and data with participants, 
medical/research communities, the media, policy makers, and the general public. This is done in a 
manner that safeguards participant privacy and informed consent while respecting the integrity of 
national regulatory systems. Clinical trial data, health-related research, and pharmacovigilance 
activities on key-coded health data transferred by BMS across national borders is done in 
compliance with the relevant data protection laws in the country and GCP requirements. 
BMS protects Personal Information with adequate and appropriate security controls as indicated 
under the data protection laws. To align with the recommended security standards, BMS has 
adopted internal security standards and policies to protect personal data at every stage of its 
processing. 
To supplement these standards, BMS enters into Clinical Trial Agreements (CTAgs) with 
confidentiality obligations to ensure proper handling and protection of personal data by third 
parties accessing and handling personal data. 
BMS takes unauthorized access and disclosure of Personal Information very seriously. BMS has 
adopted the security standards that include National Institute of Standards and Technology 
Cybersecurity Framework for studies in the US. BMS aligns with these standards to continuously 
assess and improve its ability to protect, detect, and respond to cyberattacks and other unauthorized 
attempts to access personal data. These standards also aid in mitigating possible adverse effects. 
Furthermore, BMS Information Technology has defined 6 principles to protect our digital 
resources and information: 
1) Responsibilities of IT Personnel 
2) Securing the BMS Digital Infrastructure 

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3) Identity and Access Management 
4) External Partner Connections 
5) Cyber Threat Detection and Response 
6) Internal Cyber Incident Investigation 
 
SOURCE DOCUMENTS 
The Investigator is responsible for ensuring that the source data are accurate, legible, 
contemporaneous, original and attributable, whether the data are hand-written on paper or entered 
electronically. If source data are created (first entered), modified, maintained, archived, retrieved, 
or transmitted electronically via computerized systems (and/or any other kind of electronic 
devices) as part of regulated clinical trial activities, such systems must be compliant with all 
applicable laws and regulations governing use of electronic records and/or electronic signatures. 
Such systems may include, but are not limited to, electronic medical/health records (EMRs/EHRs), 
adverse event tracking/reporting, protocol required assessments, and/or drug accountability 
records). 
When paper records from such systems are used in place of electronic format to perform regulated 
activities, such paper records should be certified copies. A certified copy consists of a copy of 
original information that has been verified, as indicated by a dated signature, as an exact copy 
having all of the same attributes and information as the original. 
STUDY TREATMENT RECORDS 
Records for study treatments (whether supplied by BMS, its vendors, or the site) must substantiate 
study treatment integrity and traceability from receipt, preparation, administration, and through 
destruction or return. Records must be made available for review at the request of BMS/designee 
or a Health Authority. 

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If 
Then 
Supplied 
vendors): 
by 
BMS 
(or 
its Records or logs must comply with applicable regulations and 
guidelines and should include: 
• amount received and placed in storage area 
• amount currently in storage area 
• label identification number or batch number 
• amount dispensed to and returned by each participant, 
including unique participant identifiers 
• amount transferred to another area/site for dispensing or 
storage 
• nonstudy disposition (e.g., lost, wasted) 
• amount destroyed at study site, if applicable 
• amount returned to BMS 
• retain samples for bioavailability/bioequivalence, if 
applicable 
• dates and initials of person responsible for 
Investigational Product dispensing/accountability, as per 
the Delegation of Authority Form. 
Sourced 
by 
site, 
and 
not 
supplied by BMS or its vendors 
(examples include IP sourced 
from 
the 
sites 
stock 
or 
commercial 
supply, 
or 
a 
specialty pharmacy) 
The investigator or designee accepts responsibility for 
documenting traceability and study treatment integrity in 
accordance with requirements applicable under law and the 
SOPs/standards of the sourcing pharmacy. 
BMS or designee will provide forms to facilitate inventory control if the investigational site does 
not have an established system that meets these requirements. 
CASE REPORT FORMS 
An investigator is required to prepare and maintain adequate and accurate case histories designed 
to record all observations and other data pertinent to the investigation on each individual treated 
or entered as a control in the investigation. Data that are derived from source documents and 
reported on the CRF must be consistent with the source documents or the discrepancies must be 
explained. Additional clinical information may be collected and analyzed in an effort to enhance 
understanding of product safety. CRFs may be requested for AEs and/or laboratory abnormalities 
that are reported or identified during the course of the study. 
For sites using the Sponsor or designee electronic data capture tool, electronic CRFs will be 
prepared for all data collection fields except for fields specific to SAEs and pregnancy, which will 
be reported on the electronic SAE form and Pregnancy Surveillance form, respectively. If 
electronic SAE form is not available, a paper SAE form can be used. 

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The confidentiality of records that could identify participants must be protected, respecting the 
privacy and confidentiality rules in accordance with the applicable regulatory requirement(s). 
The investigator will maintain a signature sheet to document signatures and initials of all persons 
authorized to make entries and/or corrections on CRFs. 
The completed CRF, SAE/pregnancy CRFs, must be promptly reviewed, signed, and dated by the 
investigator or qualified physician who is a subinvestigator and who is delegated this task on the 
Delegation of Authority Form. Subinvestigators in Japan may not be delegated the CRF approval 
task. For electronic CRFs, review and approval/signature is completed electronically through the 
BMS electronic data capture tool. The investigator must retain a copy of the CRFs including 
records of the changes and corrections. 
Each individual electronically signing electronic CRFs must meet Sponsor or designee training 
requirements and must only access the BMS electronic data capture tool using the unique user 
account provided by Sponsor or designee. User accounts are not to be shared or reassigned to other 
individuals 
MONITORING 
Monitoring details describing strategy, including definition of study critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques (central, 
remote, or on-site monitoring) are provided in the monitoring plan. 
Representatives of BMS must be allowed to visit all study site locations periodically to assess the 
data quality and study integrity. On site they will review study records and directly compare them 
with source documents, discuss the conduct of the study with the investigator, and verify that the 
facilities remain acceptable Certain CRF pages and/or electronic files may serve as the source 
documents: 
In addition, the study may be evaluated by Sponsor or designee internal auditors and government 
inspectors who must be allowed access to CRFs, source documents, other study files, and study 
facilities. BMS audit reports will be kept confidential. 
The investigator must notify BMS promptly of any inspections scheduled by regulatory authorities, 
and promptly forward copies of inspection reports to Sponsor or designee. 
RECORDS RETENTION 
The investigator (or head of the study site in Japan) must retain all study records and source 
documents for the maximum period required by applicable regulations and guidelines, or 
institution procedures, or for the period specified by BMS or designee, whichever is longer. The 
investigator (or head of the study site in Japan) must contact BMS prior to destroying any records 
associated with the study. 
BMS or designee will notify the investigator (or head of the study site in Japan) when the study 
records are no longer needed. 

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If the investigator withdraws from the study (eg, relocation, retirement), the records shall be 
transferred to a mutually agreed upon designee (eg, another investigator, study site, IRB). Notice 
of such transfer will be given in writing to BMS or designee. 
RETURN OF STUDY TREATMENT 
For this study, study treatments (those supplied by BMS, a vendor or sourced by the investigator) 
such as partially used study treatment containers, vials and syringes may be destroyed on site. 
 
If.. 
Then 
Study treatments supplied by BMS (including 
its vendors 
Any unused study treatments supplied by BMS 
can only be destroyed after being inspected and 
reconciled by the responsible Study Monitor 
unless study treatments containers must be 
immediately destroyed as required for safety, 
or to meet local regulations (eg, cytotoxics or 
biologics). 
If study treatments will be returned, the return 
will be arranged by the responsible Study 
Monitor. 
Study treatments sourced by site, not supplied 
by BMS (or its vendors) (examples include 
study treatments sourced from the sites stock 
or 
commercial 
supply, 
or 
a 
specialty 
pharmacy) 
It 
is 
the 
investigator’s 
or 
designee’s 
responsibility to dispose of all containers 
according to the institutional guidelines and 
procedures. 
 
It is the investigator’s or designee’s responsibility to arrange for disposal, provided that procedures 
for proper disposal have been established according to applicable federal, state, local, and 
institutional guidelines and procedures, and provided that appropriate records of disposal are kept. 
The following minimal standards must be met: 
• On-site disposal practices must not expose humans to risks from the drug. 
• On-site disposal practices and procedures are in agreement with applicable laws and 
regulations, including any special requirements for controlled or hazardous substances. 
• Written procedures for on-site disposal are available and followed. The procedures must be 
filed with the site’s SOPs and a copy provided to BMS upon request. 
• Records are maintained that allow for traceability of each container, including the date 
disposed of, quantity disposed, and identification of the person disposing the containers. The 
method of disposal, ie, incinerator, licensed sanitary landfill, or licensed waste disposal vendor 
must be documented. 
• Accountability and disposal records are complete, up-to-date, and available for the Monitor to 
review throughout the clinical trial period. 

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It is the investigator’s or designee’s responsibility to arrange for disposal of all empty containers. 
If conditions for destruction cannot be met the responsible Study Monitor will make arrangements 
for return of study treatments provided by BMS (or its vendors). Destruction of non- study 
treatments sourced by the site, not supplied by BMS, is solely the responsibility of the investigator 
or designee. 
DISSEMINATION OF CLINICAL STUDY DATA 
In order to benefit potential study participants, patients, healthcare providers and researchers, and 
to help BMS honor its commitments to study participants, BMS will make information about 
clinical research studies and a summary of their results available to the public as per regulatory 
and BMS requirements. BMS will post study information on local, national or regional databases 
in compliance with national and international standards for disclosure. BMS may also voluntarily 
disclose information to applicable databases. 
CLINICAL STUDY REPORT AND PUBLICATIONS 
A Signatory Investigator must be selected to sign the clinical study report. 
• External Principal Investigator designated at protocol development 
• National Coordinating Investigator 
• Study Steering Committee chair or their designee 
• Participant recruitment (eg, among the top quartile of enrollers) 
• Involvement in trial design 
• Regional representation (eg, among top quartile of enrollers from a specified region or country) 
• Other criteria (as determined by the study team) 
 
The data collected during this study are confidential and proprietary to Sponsor or designee. Any 
publications or abstracts arising from this study must adhere to the publication requirements set 
forth in the clinical trial agreement (CTAg) governing [Study site or Investigator] participation in 
the study. These requirements include, but are not limited to, submitting proposed publications to 
Sponsor or designee at the earliest practicable time prior to submission or presentation and 
otherwise within the time period set forth in the CTAg. 

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APPENDIX 3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS: 
DEFINITIONS AND PROCEDURES FOR RECORDING, 
EVALUATING, FOLLOW UP AND REPORTING 
ADVERSE EVENTS 
 
Adverse Event Definition: 
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a 
preexisting medical condition in a clinical investigation participant administered study treatment 
and that does not necessarily have a causal relationship with this treatment. 
An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory 
finding), symptom, or disease temporally associated with the use of study treatment, whether or 
not considered related to the study treatment. 
Events Meeting the AE Definition 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
results from other safety assessments (eg, ECG, radiological scans, vital signs 
measurements), including those that worsen from baseline, considered clinically significant 
in the medical and scientific judgment of the investigator. Note that abnormal lab tests or 
other safety assessments should only be reported as AEs if the final diagnosis is not 
available. Once the final diagnosis is known, the reported term should be updated to be the 
diagnosis. 
• Exacerbation of a chronic or intermittent pre-existing condition including either an increase 
in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study intervention administration even though it 
may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study intervention 
or a concomitant medication. Overdose, as a verbatim term (as reported by the investigator), 
should not be reported as an AE/SAE unless it is an intentional overdose taken with possible 
suicidal/self-harming intent. Such overdoses should be reported regardless of sequelae and 
should specify "intentional overdose" as the verbatim term 
Events NOT Meeting the AE Definition 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE. 
• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
 
DEFINITION OF SAE 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met. 

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SERIOUS ADVERSE EVENTS 
 
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any 
dose: 
Results in death 
Is life-threatening (defined as an event in which the participant was at risk of death at the time 
of the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe) 
Requires inpatient hospitalization or causes prolongation of existing hospitalization (see NOTE 
below) 
NOTE: 
The following hospitalizations are not considered SAEs in BMS clinical studies: 
• a visit to the emergency room or other hospital department < 24 hours, that does not result 
in admission (unless considered an important medical or life-threatening event) 
• elective surgery, planned prior to signing consent 
• admissions as per protocol for a planned medical/surgical procedure 
• routine health assessment requiring admission for baseline/trending of health status (e.g., 
routine colonoscopy) 
• medical/surgical admission other than to remedy ill health and planned prior to entry into 
the study. Appropriate documentation is required in these cases 
• admission encountered for another life circumstance that carries no bearing on health status 
and requires no medical/surgical intervention (e.g., lack of housing, economic inadequacy, 
caregiver respite, family circumstances, administrative reason) 
• admission for administration of anticancer therapy in the absence of any other SAEs (applies 
to oncology protocols) 
Results in persistent or significant disability/incapacity 
Is a congenital anomaly/birth defect 
Is an important medical event (defined as a medical event(s) that may not be immediately life- 
threatening or result in death or hospitalization but, based upon appropriate medical and 
scientific judgment, may jeopardize the participant or may require intervention [e.g., medical, 
surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples 
of such events include, but are not limited to, intensive treatment in an emergency room or at 
home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization.) Potential drug induced liver injury (DILI) is also considered an important 
medical event. (See Section 9.2.7 for the definition of potential DILI.) 

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Pregnancy and potential drug induced liver injury (DILI) must follow the same transmission timing 
and processes to BMS as used for SAEs (see section 9.2.5 for reporting pregnancies). 
Any component of a study endpoint that is considered related to study therapy should be reported 
as SAE (e.g., death is an endpoint, if death occurred due to anaphylaxis, anaphylaxis must be 
reported). 
EVALUATING AES AND SAES 
 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE. 
• A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk 
factors, as well as the temporal relationship of the event to study intervention administration 
will be considered and investigated. 
• The investigator will also consult the Investigator’s Brochure (IB) and/or Product 
Information, for marketed products, in his/her assessment. 
• For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality. 
• There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to Sponsor. However, it is very important that the 
investigator always make an assessment of causality for every event before the initial 
transmission of the SAE data to Sponsor. 
• The investigator may change his/her opinion of causality in light of follow-up information 
and send a SAE follow-up report with the updated causality assessment. 
• The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
 
Follow-up of AEs and SAEs 
If only limited information is initially available, follow-up reports are required. (Note: Follow- 
up SAE reports must include the same investigator term(s) initially reported.) 
If an ongoing SAE changes in its intensity or relationship to study treatment or if new 
information becomes available, the SAE report must be updated and submitted within 24 hours 
to BMS (or designee) using the same procedure used for transmitting the initial SAE report. 
All SAEs must be followed to resolution or stabilization. 

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REPORTING OF SAES TO SPONSOR OR DESIGNEE 
 
• SAEs, whether related or not related to study treatment, and pregnancies must be reported 
to BMS (or designee) immediately within 24 hours of awareness of the event. 
• SAEs must be recorded on the SAE Report Form. 
− The required method for SAE data reporting is through the eCRF. 
− The paper SAE Report Form is only intended as a back-up option when the electronic 
data capture (EDC) system is unavailable/not functioning for transmission of the eCRF 
to BMS (or designee). 
♦ In this case, the paper form is transmitted via email or confirmed facsimile (fax) 
transmission 
♦ When paper forms are used, the original paper forms are to remain on site 
• Pregnancies must be recorded on a paper Pregnancy Surveillance Form and transmitted via 
email or confirmed facsimile (fax) transmission 
SAE Email Address: Refer to Contact Information list. 
SAE Facsimile Number: Refer to Contact Information list. 
SAE Telephone Contact (required for SAE and pregnancy reporting): Refer to Contact 
Information list 

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APPENDIX 4 
WOMEN OF CHILDBEARING POTENTIAL DEFINITIONS AND 
METHODS OF CONTRACEPTION 
DEFINITIONS 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile. Permanent sterilization methods include hysterectomy, bilateral 
salpingectomy, and bilateral oophorectomy. 
Women in the following categories are not considered WOCBP 
• Premenarchal 
• Premenopausal female with 1 of the following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
 
Note: Documentation can come from the site personnel’s review of the participant’s medical 
records, medical examination, or medical history interview. 
• Postmenopausal female 
− A postmenopausal state is defined as 12 months of amenorrhea in a woman over age 45 
years in the absence of other biological or physiological causes. In addition, females under 
the age of 55 years must have a serum follicle stimulating hormone, (FSH) level > 40 
mIU/mL to confirm menopause. 
 
CONTRACEPTION GUIDANCE FOR FEMALE PARTICIPANTS OF CHILD BEARING 
POTENTIAL 
One of the highly effective methods of contraception listed below is required during study duration 
and until the end of relevant systemic exposure, defined as 5 months after the end of study 
treatment, or according to local Product label requirements for individual chemotherapy agents, 
whichever is longer.* 
 
 
Highly Effective Contraceptive Methods That Are User Dependent 
Failure rate of <1% per year when used consistently and correctly.a 
• 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with 
inhibition of ovulationb 
− oral 
− intravaginal 
− transdermal 

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• 
Progestogen-only hormonal contraception associated with inhibition of ovulationb 
− oral 
− injectable 
Highly Effective Methods That Are User Independent 
• Implantable progestogen-only hormonal contraception associated with inhibition of 
ovulation b 
• Intrauterine hormone-releasing system (IUS)c 
• Intrauterine device (IUD)c 
• 
Bilateral tubal occlusion 
• 
Vasectomized partner 
A vasectomized partner is a highly effective contraception method provided that the partner 
is the sole male sexual partner of the WOCBP and the absence of sperm has been confirmed. 
If not, an additional highly effective method of contraception should be used. 
• 
Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from 
heterosexual intercourse during the entire period of risk associated with the study drug. The 
reliability of sexual abstinence needs to be evaluated in relation to the duration of the study 
and the preferred and usual lifestyle of the participant. 
• It is not necessary to use any other method of contraception when complete abstinence is 
elected. 
• WOCBP participants who choose complete abstinence must continue to have pregnancy 
tests, as specified in Section 2. 
• Acceptable alternate methods of highly effective contraception must be discussed in the 
event that the WOCBP participants chooses to forego complete abstinence 
NOTES: 
a Typical use failure rates may differ from those when used consistently and correctly. Use should be consistent 
with local regulations regarding the use of contraceptive methods for participants participating in clinical studies. 
b Hormonal contraception may be susceptible to interaction with the study drug, which may reduce the efficacy 
of the contraceptive method. Hormonal contraception is permissible only when there is sufficient evidence that 
the IMP and other study medications will not alter hormonal exposures such that contraception would be 
ineffective or result in increased exposures that could be potentially hazardous. In this case, alternative methods 
of contraception should be utilized. 
c Intrauterine devices and intrauterine hormone releasing systems are acceptable methods of contraception in the 
absence of definitive drug interaction studies when hormone exposures from intrauterine devices do not alter 
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Unacceptable Methods of Contraception* 
• Male or female condom with or without spermicide. Male and female condoms cannot be 
used simultaneously 
• Diaphragm with spermicide 
• Cervical cap with spermicide 
• Vaginal Sponge with spermicide 
• Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the 
primary mechanism of action 
• Periodic abstinence (calendar, symptothermal, post-ovulation methods) 
• Withdrawal (coitus interruptus). 
• Spermicide only 
• Lactation amenorrhea method (LAM) 
 
* Local laws and regulations may require use of alternative and/or additional contraception 
methods. 
 
CONTRACEPTION GUIDANCE FOR MALE PARTICIPANTS WITH PARTNER(S) OF 
CHILD BEARING POTENTIAL. 
Male participants with female partners of childbearing potential are eligible to participate if they 
agree to the following during the treatment and until the end of relevant systemic exposure. 
• Inform any and all partner(s) of their participation in a clinical drug study and the need to 
comply with contraception instructions as directed by the investigator. 
• Male participants are required to use a condom for study duration and until end of relevant 
systemic exposure defined as 7 months after the end of study treatment, or according to local 
Product label requirements for individual chemotherapy agents, whichever is longer. 
• Female partners of males participating in the study to consider use of effective methods of 
contraception until the end of relevant systemic exposure, defined as 7 months after the end of 
treatment in the male participant, or according to local Product label requirements for 
individual chemotherapy agents, whichever is longer. 
• Male participants with a pregnant or breastfeeding partner must agree to remain abstinent from 
penile vaginal intercourse or use a male condom during each episode of penile penetration 
during the treatment and until 7 months after the end of study treatment, or according to local 
Product label requirements for individual chemotherapy agents, whichever is longer. 
• Refrain from donating sperm for the duration of the study treatment and until 7 months after 
the end of study treatment, or according to local Product label requirements for individual 
chemotherapy agents, whichever is longer. 

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COLLECTION OF PREGNANCY INFORMATION 
Guidance for collection of Pregnancy Information and outcome of pregnancy on the Pregnancy 
Surveillance Form is provided in Section 9.2.5 and the Appendix for Adverse Events and Serious 
Adverse Events Definitions and procedures for Evaluating, Follow-up and Reporting 

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APPENDIX 5 
ECOG PERFORMANCE STATUS 
 
ECOG PERFORMANCE STATUS a 
0 
Fully active, able to carry on all pre-disease performance without restriction 
1 
Restricted in physically strenuous activity but ambulatory and able to carry out work of a 
light or sedentary nature, eg, light house work, office work 
2 
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and 
about more than 50% of waking hours 
3 
Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours 
4 
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair 
5 
Dead 
a Oken MM, Creech RH, Tormey DC, et al. Toxicity and Response Criteria of the Eastern Cooperative Oncology 
Group. Am J Clin Oncol 1982; 5: 649-655. 

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APPENDIX 6 
MANAGEMENT ALGORITHMS FOR STUDIES UNDER CTCAE 
VERSION 4.0 
These general guidelines constitute guidance to the Investigator and may be supplemented by 
discussions with the Medical Monitor representing the Sponsor. The guidance applies to all 
immuno-oncology agents and regimens. 
For additional guidance on management of durvalumab-related toxicity, please refer to the 
approved Product Label for durvalumab. 
A general principle is that differential diagnoses should be diligently evaluated according to 
standard medical practice. Non-inflammatory etiologies should be considered and appropriately 
treated. 
Corticosteroids are a primary therapy for immuno-oncology drug-related adverse events. The oral 
equivalent of the recommended IV doses may be considered for ambulatory patients with low- 
grade toxicity. The lower bioavailability of oral corticosteroids should be taken into account when 
switching to the equivalent dose of oral corticosteroids. 
Consultation with a medical or surgical specialist, especially prior to an invasive diagnostic or 
therapeutic procedure, is recommended. 
The frequency and severity of the related adverse events covered by these algorithms will depend 
on the immuno-oncology agent or regimen being used. 

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APPENDIX 7 
RESPONSE EVALUATION CRITERIA IN SOLID TUMORS 
GUIDELINES (VERSION 1.1) WITH BMS MODIFICATIONS 
1 
EVALUATION OF LESIONS 
Solid tumors will be evaluated using Response Evaluation Criteria In Solid Tumors version 1.1 
(RECIST 1.1) guideline with BMS modifications.1 
At baseline, tumor lesions/lymph nodes will be categorized as measurable or non-measurable as 
follows: 
1.1 
Measurable 
Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the 
plane of measurement is to be recorded) with a minimum size of: 
• 10 mm by CT/MRI scan (scan slice thickness no greater than 5 mm), or ≥2x slice thickness if 
greater than 5mm. 
Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node 
must be ≥ 15 mm in short axis when assessed by CT/MRI scan (scan slice thickness recommended 
to be no greater than 5 mm). 
Lymph nodes merit special mention since they are normal anatomical structures which may be 
visible by imaging even if not involved by tumor. Pathological nodes which are defined as 
measurable and may be identified as target lesions must meet the criterion of a short axis of 
≥ 15 mm by CT/MRI scan. Only the short axis of these nodes will contribute to the baseline sum. 
The short axis of the node is the diameter normally used by radiologists to judge if a node is 
involved by solid tumor. Nodal size is normally reported as two dimensions in the plane in which 
the image is obtained (for CT scan this is almost always the axial plane; for MRI the plane of 
acquisition may be axial, sagittal or coronal). The smaller of these measures is the short axis. For 
example, an abdominal node which is reported as being 20 mm x 30 mm has a short axis of 20 mm 
and qualifies as a malignant, measurable node. In this example, 20 mm should be recorded as the 
node measurement. All other pathological nodes (those with short axis ≥ 10 mm but < 15 mm) 
should be considered non-target lesions. Nodes that have a short axis < 10 mm are considered 
non-pathological and should not be recorded or followed. 
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions. 
1.2 
Non-Measurable 
All other lesions are considered non-measurable, including small lesions (longest diameter 
< 10mm or pathological lymph nodes with ≥ 10 to < 15 mm short axis) as well as truly 
non-measurable lesions. Lesions considered truly non-measurable include: leptomeningeal 
disease, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal 
masses/abdominal organomegaly identified by physical exam that is not measurable by 
reproducible imaging techniques. 
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions. 

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1.3 
Special Considerations Regarding Lesion Measurability 
1.3.1 
Bone lesions 
• Bone scan, PET scan and plain films are not considered adequate imaging techniques to 
measure bone lesions. However, these techniques can be used to confirm the presence or 
disappearance of bone lesions. 
• Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that 
can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered 
as measurable lesions if the soft tissue component meets the definition of measurability 
described above. 
• Blastic bone lesions are non-measurable. 
• 
1.4 
Baseline Documentation Of ‘Target’ And ‘Non-Target’ Lesions 
When more than one measurable lesion is present at baseline all lesions up to a maximum of five 
lesions total (and a maximum of two lesions per organ) representative of all involved organs should 
be identified as target lesions and will be recorded and measured at baseline (this means in 
instances where patients have only one or two organ sites involved a maximum of two and four 
lesions respectively will be recorded). 
Note: A maximum of two lesions can be selected per organ system. For example, a maximum of 
two lung lesions can be selected (selected from one lung or one lesion from each). A maximum of 
two lymph nodes can be selected at baseline, as the lymphatic system is considered one organ. 
Target lesions should be selected on the basis of their size (lesions with the longest diameter), be 
representative of all involved organs, but in addition should be those that lend themselves to 
reproducible repeated measurements. It may be the case that, on occasion, the largest lesion does 
not lend itself to reproducible measurement in which circumstance the next largest lesion which 
can be measured reproducibly should be selected. 
A sum of the diameters (longest for non-nodal lesions, short axis for nodal lesions) for all target 
lesions will be calculated and reported as the baseline sum diameters. If lymph nodes are to be 
included in the sum, then as noted above, only the short axis is added into the sum. The baseline 
sum diameters will be used as reference to further characterize any objective tumor regression in 
the measurable dimension of the disease. 
All other lesions (or sites of disease) including pathological lymph nodes should be identified as 
non-target lesions and should also be recorded at baseline. Measurements are not required and 
these lesions should be followed as ‘present’, ‘absent’, or in rare cases ‘unequivocal progression’ 
(more details to follow). In addition, it is possible to record multiple non-target lesions involving 
the same organ as a single item on the case record form (eg, ‘multiple enlarged pelvic lymph nodes’ 
or ‘multiple liver metastases’). 

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2 
RESPONSE CRITERIA 
2.1 
Evaluation of Target Lesions 
• Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes 
(whether target or non-target) must have reduction in short axis to < 10 mm. 
• Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, 
taking as reference the baseline sum diameters. 
• Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, 
taking as reference the smallest sum on study (this includes the baseline sum if that is the 
smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate 
an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also 
considered progression). 
• Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to 
qualify for PD, taking as reference the smallest sum diameters while on study. 
• Not Evaluable (NE): If one or more target lesions cannot be measured or adequately assessed 
as either fully resolved or too small to measure (due to missing or poor quality images), and 
the sum of diameters of the remaining measured target lesions (if any) has not increased 
sufficiently to meet Progressive Disease as defined above. 
 
2.1.1 
Special Notes on the Assessment of Target Lesions 
2.1.1.1 
Lymph nodes 
Lymph nodes identified as target lesions should always have the actual short axis measurement 
recorded (measured in the same anatomical plane as the baseline examination), even if the nodes 
regress to below 10 mm on study. This means that when lymph nodes are included as target lesions, 
the ‘sum’ of lesions may not be zero even if complete response criteria are met, since a normal 
lymph node is defined as having a short axis of < 10 mm. Case report forms or other data collection 
methods may therefore be designed to have target nodal lesions recorded in a separate section 
where, in order to qualify for CR, each node must achieve a short axis < 10 mm. For PR, SD and 
PD, the actual short axis measurement of the nodes is to be included in the sum of target lesions. 
2.1.1.2 
Target lesions that become ‘too small to measure’ 
While on study, all lesions (nodal and non-nodal) recorded at baseline should have their actual 
measurements recorded at each subsequent evaluation, even when very small (eg, 2 mm). 
However, sometimes lesions or lymph nodes which are recorded as target lesions at baseline 
become so faint on CT scan that the radiologist may not feel comfortable assigning an exact 
measure and may report them as being ‘too small to measure’. When this occurs it is important 
that a value be recorded on the case report form. If it is the opinion of the radiologist that the lesion 
has likely disappeared, the measurement should be recorded as 0 mm. If the lesion is believed to 
be present and is faintly seen but too small to measure, a default value of 5 mm should be assigned 
as the reference diameter. (Note: It is less likely that this rule will be used for lymph nodes since 
they usually have a definable size when normal and are frequently surrounded by fat such as in the 
retroperitoneum; however, if a lymph node is believed to be present and is faintly seen but too 
small to measure, a default value of 5 mm should be assigned in this circumstance as well). This 

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default value is derived from the 5 mm CT slice thickness (but should not be changed with varying 
CT slice thickness). The measurement of these lesions is potentially non-reproducible, therefore 
providing this default value will prevent false responses or progressions based upon measurement 
error. To reiterate, however, if the radiologist is able to provide an actual measure, that should be 
recorded, even if it is below 5 mm. 
2.1.1.3 
Lesions that split or coalesce on treatment 
When non-nodal lesions ‘fragment’, the longest diameters of the fragmented portions should be 
added together to calculate the target lesion sum. Similarly, as lesions coalesce, a plane between 
them may be maintained that would aid in obtaining maximal diameter measurements of each 
individual lesion. If the lesions have truly coalesced such that they are no longer separable, the 
vector of the longest diameter in this instance should be the maximal longest diameter for the 
‘coalesced lesion’. 
2.2 
Evaluation of Non-Target Lesions 
This section provides the definitions of the criteria used to determine the tumor response for the 
group of non-target lesions. While some non-target lesions may actually be measurable, they need 
not be measured and instead should be assessed only qualitatively at the time points specified in 
the protocol. 
• Complete Response (CR): Disappearance of all non-target lesions. All lymph nodes must be 
non-pathological in size (< 10mm short axis). 
• Non-CR/Non-PD: Persistence of one or more non-target lesion(s) 
• Progressive Disease (PD): Unequivocal progression of existing non-target lesions. 
 
2.2.1 
Special Notes on Assessment of Progression of Non-Target Disease 
The concept of progression of non-target disease requires additional explanation as follows: 
2.2.1.1 
When the patient also has measurable disease 
In this setting, to achieve ‘unequivocal progression’ on the basis of the non-target disease, there 
must be an overall level of substantial worsening in non-target disease such that, even in presence 
of SD or PR in target disease, the overall tumor burden has increased sufficiently to merit 
discontinuation of therapy A modest ‘increase’ in the size of one or more non-target lesions is 
usually not sufficient to qualify for unequivocal progression status. Pleural effusions, pericardial 
effusions and ascites will not be followed as target or non-target lesions and will not contribute to 
response or progression. The designation of overall progression solely on the basis of change in 
non-target disease in the face of SD or PR of target disease will therefore be extremely rare. 
2.2.1.2 
When the patient has only non-measurable disease 
This circumstance arises in some trials when it is not a criterion of study entry to have measurable 
disease. The same general concepts apply here as noted above, however, in this instance there is 
no measurable disease assessment to factor into the interpretation of an increase in non-measurable 
disease burden. Because worsening in non-target disease cannot be easily quantified (by definition: 

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if all lesions are truly non-measurable) a useful test that can be applied when assessing patients for 
unequivocal progression is to consider if the increase in overall disease burden based on the change 
in non-measurable disease is comparable in magnitude to the increase that would be required to 
declare PD for measurable disease: ie, an increase in tumor burden representing an additional 73% 
increase in ‘volume’ (which is equivalent to a 20% increase diameter in a measurable lesion). 
Examples include, an increase in lymphangitic disease from localized to widespread, or may be 
described as ‘sufficient to require a change in therapy’. If ‘unequivocal progression’ is seen, the 
patient should be considered to have had overall PD at that point. While it would be ideal to have 
objective criteria to apply to non-measurable disease, the very nature of that disease makes it 
impossible to do so; therefore the increase must be substantial. 
2.2.2 
New Lesions 
The appearance of new malignant lesions denotes disease progression; therefore, some comments 
on detection of new lesions are important. There are no specific criteria for the identification of 
new radiographic lesions; however, the finding of a new lesion should be unequivocal: ie, not 
attributable to differences in scanning technique, change in imaging modality or findings thought 
to represent something other than tumor (for example, some ‘new’ bone lesions may be simply 
healing or flare of pre-existing lesions). This is particularly important when the patient’s baseline 
lesions show partial or complete response. For example, necrosis of a liver lesion may be reported 
on a CT scan report as a ‘new’ cystic lesion, which it is not. 
NOTE: Fluid collections (pleural effusions, pericardial effusions, and ascites) will not be 
considered new lesions and will not contribute to response or progression. In the event a new fluid 
collection is seen on a post-baseline imaging exam, a comment may be made, but the appearance 
of a new fluid collection alone should not result in an assessment of Progressive Disease (PD). A 
lesion identified on a follow-up study in an anatomical location that was not scanned at baseline 
is considered a new lesion and will indicate disease progression. An example of this is the patient 
who has visceral disease at baseline and while on study has a CT or MRI brain ordered which 
reveals metastases. The patient’s brain metastases are considered to be evidence of PD even if 
he/she did not have brain imaging at baseline. A lesion identified on Chest X-Ray that was not 
present in prior CT can be considered a new lesion and will result in Progressive Disease (PD). 
If a new lesion is equivocal, for example because of its small size, continued follow-up evaluation 
will clarify if it represents truly new disease. If repeat scans confirm there is definitely a new 
lesion, then progression should be declared using the date of the initial scan. While FDG-PET 
response assessments need additional study, it is sometimes reasonable to incorporate the use of 
FDG-PET scanning to complement CT scanning in assessment of progression (particularly 
possible ‘new’ disease). New lesions on the basis of FDG-PET imaging can be identified according 
to the following algorithm: 
1) Negative FDG-PET at baseline, with a positive FDG-PET at follow-up is a sign of PD based 
on a new lesion. 

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2) No FDG-PET at baseline and a positive FDG-PET at follow-up: If the positive FDG-PET at 
follow-up corresponds to a new site of disease confirmed by CT, this is PD. If the positive 
FDG-PET at follow-up is not confirmed as a new site of disease on CT, additional follow-up 
CT scans are needed to determine if there is truly progression occurring at that site (if so, the 
date of PD will be the date of the initial abnormal FDG-PET scan). If the positive FDG-PET 
at follow-up corresponds to a pre-existing site of disease on CT that is not progressing on the 
basis of the anatomic images, this is not PD. 
 
2.3 
Response Assessment 
2.3.1 
Evaluation of Best Overall Response 
The best overall response is the best response recorded from the start of the study treatment until 
disease progression or the last response recorded, taking into account any requirement for 
confirmation and censoring rules regarding subsequent therapy. The patient’s best overall response 
assignment will depend on the findings of both target and non-target disease and will also take into 
consideration the appearance of new lesions. Furthermore, depending on the nature of the study 
and the protocol requirements, it may also require confirmatory measurement. 
2.3.2 
Time Point Response 
At each protocol specified time point, a response assessment occurs. Table 2.3.2-1 provides a 
summary of the overall response status calculation at each time point for patients who have 
measurable disease at baseline. When patients have non-measurable (therefore non-target) disease 
only, Table 2.3.2-2 is to be used. 
 
Table 2.3.2-1: 
Time Point Response: Patients With Target (± Non-Target) Disease 
Target Lesions 
Non-Target Lesions 
New Lesions 
Overall Response 
CR 
CR 
No 
CR 
CR 
Non-CR/non-PD 
No 
PR 
CR 
Not evaluated 
No 
PR 
PR 
Non-PD or not all 
evaluated 
No 
PR 
SD 
Non-PD or not all 
evaluated 
No 
SD 
Not all evaluated 
Non-PD 
No 
NE 
PD 
Any 
Yes or No 
PD 
Any 
PD 
Yes or No 
PD 
Any 
Any 
Yes 
PD 
CR, complete response, PR, partial response, SD, stable disease, PD, progressive disease and NE, inevaluable. 

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Table 2.3.2-2: 
Time Point Response: Patients with Non-target Disease Only 
Non-Target Lesions 
New Lesions 
Overall Response 
CR 
No 
CR 
Non-CR/non-PD 
No 
Non-CR/non-PDa 
Not all evaluated 
No 
NE 
Unequivocal PD 
Yes or No 
PD 
Any 
Yes 
PD 
CR, complete response, PD, progressive disease and NE, inevaluable. 
a Non-CR/non-PD is preferred over SD for non-target disease since SD is increasingly used as endpoint for 
assessment of efficacy in some trials so to assign this category when no lesions can be measured is not advised. 
 
2.3.3 
Best Overall Response 
Best response determination of complete or partial response requires confirmation: Complete or 
partial responses may be claimed only if the criteria for each are met at a subsequent time point of 
≥ 4 weeks (28 days) later. In this circumstance, the best overall response can be interpreted as in 
Table 2.3.3-1. When SD is believed to be best response, it must meet the protocol specified 
minimum time from the date of first treatment or randomization date. 
For example, if the first scheduled follow-up imaging visit is Week 6 (± 7 days) for a particular 
protocol, a Best Response of SD can only be made after the participant is on-study for a minimum 
of 6 weeks (42 days) minus 7 days, for an absolute minimum time on-study of 35 days from the 
reference start date (reference date is considered Day 1 on study). If the participant is not on-study 
for at least this amount of time, any tumor assessment indicating stable disease before this time 
period will have a Best Response of NE unless PD is identified. 
Special note on response assessment: When nodal disease is included in the sum of target lesions 
and the nodes decrease to ‘normal’ size (< 10 mm), they may still have a measurement reported 
on scans. This measurement should be recorded even though the nodes are normal in order not to 
overstate progression should it be based on increase in size of the nodes. As noted earlier, this 
means that patients with CR may not have a total sum of ‘zero’ on the case report form (CRF). 
 
Table 2.3.3-1: 
Best Overall Response (Confirmation of CR and PR Required) 
Overall Response 
First Time Point 
Overall Response 
Subsequent Time Point 
Best Overall Response 
CR 
CR 
CR 
CR 
PR 
SD, PD OR PRa 
CR 
SD 
SD provided minimum criteria for SD duration met, otherwise, 
PD 
CR 
PD 
SD provided minimum criteria for SD duration met, otherwise, 
PD 

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Table 2.3.3-1: 
Best Overall Response (Confirmation of CR and PR Required) 
Overall Response 
First Time Point 
Overall Response 
Subsequent Time Point 
Best Overall Response 
CR 
NE 
SD provided minimum criteria for SD duration met, otherwise, 
NE 
PR 
CR 
PR 
PR 
PR 
PR 
PR 
SD 
SD 
PR 
PD 
SD provided minimum criteria for SD duration met, otherwise, 
PD 
PR 
NE 
SD provided minimum criteria for SD duration met, otherwise, 
NE 
NE 
NE 
NE 
CR, complete response, PR, partial response, SD, stable disease, PD, progressive disease, and NE, inevaluable. 
a If a CR is truly met at first time point, then any disease seen at a subsequent time point, even disease meeting PR 
criteria relative to baseline, makes the disease PD at that point (since disease must have reappeared after CR). Best 
response would depend on whether minimum duration for SD was met. However, sometimes ‘CR’ may be claimed 
when subsequent scans suggest small lesions were likely still present and in fact the patient had PR, not CR at the 
first time point. Under these circumstances, the original CR should be changed to PR and the best response is PR. 
2.3.4 
Confirmation Scans 
Verification of Response: To be assigned a status of CR or PR, changes in tumor measurements 
must be confirmed by consecutive or subsequent repeat assessments that should be performed no 
less than 28 days after the criteria for response are first met. Subsequent documentation of a CR 
may provide confirmation of a previously identified CR even with an intervening NE or PR (eg, 
CR NE CR or CR PR CR). Subsequent documentation of a PR may provide confirmation of a 
previously identified PR even with an intervening NE or SD (eg, PR NE PR or PR SD PR). 
However, only one (1) intervening time point will be allowed between PR/CRs for confirmation. 
Verification of Progression: Progression of disease should be verified in cases where progression 
is equivocal. If repeat scans confirm PD, then progression should be declared using the date of the 
initial scan. If repeat scans do not confirm PD, then the participant is considered to not have 
progressive disease. 
REFERENCES 
1. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumors: 
revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45: 228-47. 

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APPENDIX 8 
SUMMARY OF RECOMMENDATIONS FOR NODAL GTV 
DELINEATION BASED ON FDG-PET–CT AND E(B)US-NA 
 
When incidental nodal irradiation is low, such as with IMRT or VMAT, it is advised to add 
E(B)US-NA to FDG-PET–CT for mediastinal staging as it may: 
• decrease geographical miss 
• detect other benign reasons for PET-positivity 
• confirm malignancy in PET-positive LN 
Do NOT exclude LN that are PET-positive and E(B)US-negative from GTV as FN rate 
remains high (14%-16%), except if: 
• a clear benign reason for PET-positivity is found at pathological examination e.g. 
anthracosilicosis or granulomatosis 
• high suspicion of infection with symmetrical pattern and less FDG-avid compared with 
primary tumor; take into account clinical parameters 
• negative pathology at E(B)US-NA is confirmed by mediastinoscopy 
Select carefully which LN station to be sampled with E(B)US under local anesthesia: 
• confirm malignancy or find benign etiology for PET-positivity 
• sample “suspicious” PET-negative LN 
• consider to discuss the selection of critical LN with endoscopist beforehand 
• E(B)US should be performed after FDG-PET–CT scan to avoid FN PET-positive LN 
Abbreviations: GTV = gross tumor volume; E(B)US-NA = endobronchial/esophageal 
ultrasound with needle aspiration; IMRT = intensity-modulated radiotherapy; VMAT = 
volumetric arc therapy; FN = false negative 
SOURCE: Peeters ST, Dooms C, Van Baardwijk A, et al. Selective Mediastinal Node Irradiation 
in Non-Small Cell Lung Cancer in the Imrt/Vmat Era: How to Use E(B)Us-Na Information in 
Addition to Pet-Ct for Delineation? Radiother Oncol. 2016:120(2):273-8 

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APPENDIX 9 
COUNTRY-SPECIFIC REQUIREMENTS FOR HIV TESTING 
Argentina has additional requirements for exclusion of HIV positive participants and is locally 
mandated. 
 
Original language 
Country-specific language 
Section 6.2.1 Exclusion Criteria 
for CCRT, 
Exclusion criterion 1 m) 
“Known history of testing positive for human immunodeficiency virus (HIV) 
or known acquired immunodeficiency syndrome (AIDS)”to be replaced with 
“Positive test for HIV”. 
Table 9.4.4-1 Clinical Laboratory 
Assessments 
Add: HIV at screening 
Abbreviations: AIDS, acquired immunodeficiency syndrome; CCRT, concurrent chemoradiotherapy, HIV, human 
immunodeficiency virus. 

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APPENDIX 10 
REVISED PROTOCOL SUMMARY OF CHANGE HISTORY 
Overall Rationale for Protocol Amendment 02, 16-Aug-2021 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Global 
Editorial changes (ie, grammar, 
punctuation, abbreviations, etc). 
Improved readability. Minor, 
therefore have not been 
summarized. 
Title Page 
Updated contact name and role name. 
Study Director is now referred to as 
Clinical Scientist. 
Change in study contact 
personnel. 

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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
Synopsis 
Updated with changes in Section 2-10. 
Consistency with main body of 
protocol. 
2, Schedule of Activities; Table 2-1, 
Table 2-2, Table 2-3, Table 2-4, 
Table 2-5, Table 2-6, Table 2-7, and 
Table 2-8 
6.2.1, Exclusion Criteria for CCRT 
Added language to the protocol for 
participants with suspected or 
confirmed SARS-CoV-2 infection. 
• 
6.4.1, Retesting During Screening 
Period 
7.4, Dosage Modification 
• 
AE/SAE language to all Section 2 
tables and Section 9. 
9.2.1, Time Period and Frequency 
for Collecting AE and SAE 
Information 
• 
Criteria for exclusion from study, 
retesting, and dosage 
modification in Sections 6 and 7. 
9.2.3, Follow-up of AEs and SAEs 
9.8, Biomarkers; Table 9.8-1 
2, Schedule of Activities; Table 2-1 
5.1.1, Screening Period 
6.1.1, Inclusion Criteria for CCRT 
9.8.1, Tumor Tissue Specimens 
Updated protocol to change the 
number of unstained tumor tissue 
sections that may be submitted to 
central lab at screening from 15 to 
5-10 and removed requirement to 
discuss inclusion with medical 
monitor if less than 15 slides are 
available. 
Updated Inclusion Criterion 2) e). 
To address potential enrollment 
barriers. 
2, Schedule of Activities; Table 2-1 
5.1.1, Screening Period 
1. Updated notes for Informed 
Consent row. 
2. Updated notes for Pulmonary 
Function Tests row, and for Body 
Imaging row. Section 5.1.1 was 
updated to be consistent with 
Body Imaging notes. 
1. Clarified timing of consent 
collection and requirement 
for re-consent and new 
participant number with re- 
enrollment. 
2. Enlarged time window for 
pulmonary function tests 
and PET component to 
address real-world logistic 
challenges in scheduling 
these procedures and to 
avoid unnecessary radiation 
exposure to participants. 
2, Schedule of Activities; Table 2-1 
5.1.1, Screening Period 
6.1.1, Inclusion Criteria for CCRT 
Updated notes for Lymph Node 
Sampling row. 
Updated Inclusion Criterion 2) b). 
Updated text in Section 5.1.1. 
Added text to account for cases 
in which T3N1 cannot be 
verified by biopsy due to the 
lesion being unamenable or 
procedure is medically infeasible 
and documentation of T3N1 
status. 

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Section Number & Title 
Description of Change 
Brief Rationale 
2, Schedule of Activities; Table 2-1, 
Table 2-2, Table 2-3, Table 2-5, 
Table 2-6, and Table 2-7 
Added footnote a in Table 2-1, 
footnote c in Table 2-2 and Table 2-3, 
and footnote b in Table 2-5, Table 2-6, 
and Table 2-7. 
Added footnote to address 
assessments for safety 
monitoring that may not be 
captured on CRF. 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-5, Table 2-6, 
Table 2-7, Table 2-9, and Table 2- 
10 
Updated notes for Targeted Physical 
Examination, Weight, and Vital Signs 
(see also Targeted PE, Weight, and 
Vital Signs) row. 
Clarified timing for weight 
assessment. 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-5, Table 2-6, and 
Table 2-7. 
Table 9.4.4-1 Clinical Safety 
Laboratory Assessments 
Added row for Thyroid Stimulating 
Hormone (TSH) test. 
Updated text for TSH in 
Table 9.4.4-1. 
To clarify that TSH test (with 
reflexive fT3 and fT4 if TSH is 
abnormal) is only required on 
Day 1 of every cycle (except for 
Arm C in the CCRT period 
only). 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-4, Table 2-5, 
Table 2-6, Table 2-7, Table 2-9, and 
Table 2-10 
Updated notes for Pregnancy Test row 
updating timing of collection. 
Updated and clarified timing of 
testing. 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-5, Table 2-6, and 
Table 2-7 
Updated notes for Outcome 
Assessments. 
Updated to address collection 
when dose is delayed. 
2, Schedule of Activities; Table 2-2 
7.1.4.2, Etoposide/cisplatin 
Updated notes for Administer 
Etoposide row and text in 
Section 7.1.4.2. 
To provide flexibility for dosing 
for Day 2 and 3. 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-5, Table 2-6, and 
Table 2-7 
Added Body and/or Brain Imaging 
Row (Table 2-2 and Table 2-3). 
Footnote b added to Body Imaging 
row and Brain Imaging row 
(Table 2-4). 
Footnote d added to Body Imaging 
row and Brain Imaging row 
(Table 2-5, Table 2-6, Table 2-7, and 
Table 2-8). 
Added to address the need for 
disease progression confirmation 
by BICR prior to subsequent 
therapy. 
2, Schedule of Activities; Table 2-2, 
Table 2-3, Table 2-5, Table 2-6, 
Table 2-7, and Table 2-8 
9.8 , Biomarkers; Table 9.8-1 and 
 
9.8.1 , Tumor Tissue Specimens 
2, Schedule of Activities; Table 2-2 
and Table 2-3 
Added footnote b to Cycle column 
headers. 
Footnote added to address which 
procedures should and shouldn’t 
be delayed when dose is delayed. 
2, Schedule of Activities; Table 2-3 
Removed Day 8 and Day 15 from 
Cycle 1. 
Removed Days 8 and 15 of 
Cycle 1 as no assessments occur 
on those days. 

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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
2, Schedule of Activities; Table 2-3 
7.1.4.1, Paclitaxel/Carboplatin 
Dosing 
Updated notes for Administer 
Paclitaxel row, Administer 
Carboplatin row, and text in 
Section 7.1.4.1. 
To provide flexibility for dosing 
for Day 8 and 15. 
Added note on premedication for 
clarity. 
2, Schedule of Activities; Table 2-4 
1. Updated notes for Body Imaging 
row. 
2. Updated notes for Outcomes 
Assessments. 
3. Updated footnote a. 
1. Scan should be collected 
(not optional). 
2. Outcome assessment notes 
were updated to specify 
collection at End of 
Recovery Visit. 
3. Footnote updated to clarify 
collection of outcome 
assessments. 
2, Schedule of Activities; Table 2-4, 
Table 2-5 and Table 2-6 
5.1.3 , Recovery Period 
5.1.4 , Maintenance Period 
10.3.1 , Efficacy Analyses 
In Table 2-4 (Recovery Period), 
removed the (± 7 days) in the column 
2 header and updated notes for Body 
Imaging row. Updated footnote a in 
table and text in Sections 5.1.3 and 
5.1.4. 
Updated Study Treatment row notes in 
Table 2-5 and Table 2-6 (Maintenance 
Period) to be consistent with 
Section 5.1.4. 
Section 10.3.1 PFS per BICR for A vs 
C statistical analyses methods were 
updated to be consistent with 
Section 2 and Section 5. 
Clarified flexibility in timing of 
scheduled activities and duration 
in recovery period. 
Clarified flexibility in timing of 
maintenance treatment. 
2, Schedule of Activities; Table 2-5, 
Table 2-6, and Table 2-7 
Updated footnote a (Table 2-5, 
Table 2-6, and Table 2-7) and footnote 
b (Table 2-9 and Table 2-10). 
Updated footnote as pregnancy 
testing should follow the testing 
schedule as described in table 
notes for pregnancy testing 
procedure. 
2, Schedule of Activities, Table 2-6 
Updated notes for Nivolumab Q4W. 
Clarified timing between 
nivolumab doses. 
2, Schedule of Activities; Table 2-7 
Updated notes on the Durvalumab 
Q2W row. 
Updated to include instructions 
for weight-based dosing. 
2, Schedule of Activities; Table 2-8 
Updated notes for Adverse Events 
Assessment (including SAEs) row. 
Updated to include collection of 
drug-related adverse events 
beyond 100 days from last dose 
of study treatment. 
2, Schedule of Activities; Table 2-9 
and Table 2-10 
Updated notes for Brain Imaging row. 
Updated to make note consistent 
with body imaging notes. 

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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
3, INTRODUCTION 
3.3, Benefit/Risk Assessment 
5.4.1, Rationale for Study 
Population and Study Comparator 
Added sentence indicating that 4-year 
follow up data results were consistent 
with previously cited data. 
Added updated data for 
durvalumab. 
3.1.1, Research Hypothesis 
4, OBJECTIVES AND 
ENDPOINTS 
5.1, Overall Design; Figure 5.1-1 
10.1, Sample Size Determination 
Figure 10.1-1 
10.2, Populations for Analyses 
10.3.1, Efficacy Analyses 
Updated PFS assumptions and added 
OS for Arm A vs Arm C as a 
secondary objective. This includes 
updates for control arm assumption, 
delay effect, testing procedures, 
comparisons between arms, method of 
analysis descriptions. 
To mitigate prolonged timing, 
OS is now a key secondary 
endpoint and will be tested 
hierarchically after PFS. 
3.2.3, Clinical Experience with 
Nivolumab plus Ipilimumab 
Combination Therapy 
Removed statement about DoR for 
CA209012. 
Updated safety data for 
CheckMate 227 and added data for 
CheckMate 9LA. 
Removed TMB data for 
CheckMate 227. 
Added supporting information 
for use of nivolumab in 
combination with ipilimumab. 
Removed data that was not 
needed to support the 
combination therapy. 
3.2.4, Clinical Experience with 
Nivolumab and CCRT 
5.4.4, Rationale of Concurrent 
Scheduling of Nivolumab with 
CCRT 
5.4.6, Rationale of Backbone CCRT 
Updated text with data from 
Keynote 799. 
Added supporting information 
for use of nivolumab in 
combination with CCRT. 
3.3, Benefit/Risk Assessment 
7.7.2, Prior and Concomitant 
Medications 
Added text indicating non-live 
coronavirus disease 2019 (COVID-19) 
vaccinations will be considered a 
simple concomitant medication and 
handled in the same manner as other 
vaccines. 
Current data suggests that non- 
live vaccine for COVID-19 will 
not negatively impact the 
benefit-risk for participants in 
this study. 
4, OBJECTIVES AND 
ENDPOINTS 
For secondary analysis of ORR, 
reference to CR rate has been 
removed. 
ORR (CR+PR) is of primary 
interest and will be compared 
formally. 

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Section Number & Title 
Description of Change 
Brief Rationale 
5.1.2, CCRT Period 
7.2, Method of Treatment 
Assignment 
1. Added text in both sections for 
changes in actual vs planned 
CCRT regimen administration. 
2. Text in Section 5.1.2 changed 
“should” to “must” for start of 
radiotherapy. 
3. Added text to Section 5.1.2 to 
address cases of premature 
discontinuation of CCRT with 
reasons other than PD. 
1. Change from Administrative 
Letter 03. To document and 
trace any change in CCRT 
treatment plan. 
2. Added for clarity. 
3. Added to allow participants 
to be considered for 
continuation into the 
recovery period with 
discussion between the 
Investigator and Medical 
Monitor. 
5.1.8, Radiotherapy Quality 
Assurance and Quality Control 
Removed sentence for real-time 
sampling of at least 20% of cases for 
review. 
RT treatment plans for all 
participants will be reviewed by 
Quality, not just “at least 20%.”. 
5.4.1, Rationale for Study 
Population and Study Comparator 
Removed background statistics for 
lung cancer and reordered text. 
Sentence was removed to 
eliminate redundancy (text 
appears elsewhere in protocol) 
and paragraphs were reordered 
for flow/clarity. 
5.5.1, Justification for Dosing 
Regimen of Nivolumab 
Replaced text with updated data on 
nivolumab dosing, including 
exposure-response analyses. 
Updated to include current 
supporting data for nivolumab 
dosing. 
6, STUDY POPULATION 
Added text excluding protocol 
waivers/exemptions. 
Clarified that study will not 
approve protocol deviations to 
enrollment criteria. 

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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
6.1.1, Inclusion Criteria for CCRT 
9.2, Adverse Events 
1. Updated Inclusion Criterion 1) a) 
and Section 9.2. 
2. Updated Inclusion Criterion 2) b). 
3. Added sub criteria i) through iii) 
to Inclusion Criterion 3 b), added 
sub criteria i) and sub-sub criteria 
(1) and (2) to Inclusion Criterion 
d), and updated Inclusion 
Criterion 3) f) and added sub- 
criteria i) and ii) to 3) f). 
1. Changed from authorized to 
acceptable representative to 
be consistent with text in 
Appendix 2. For inclusion 
criteria, text in parentheses 
was added based on 
feedback from 
2. Clarified both histology and 
cytology are acceptable for 
disease diagnosis. Clarified 
patients medically unfit for 
general anesthesia/surgery 
are not eligible as intensive 
study multi-modality 
regimens may be unsafe for 
such patients. Clarified 
vertebral invasion must not 
extend into spinal cord as it 
is unlikely to comply with 
radiation dose constraints. 
3. Updated to include more 
information and guidance on 
the testing, counseling, and 
monitoring of women of 
childbearing potential 
(WOCBP), male partners of 
WOCBP, and contraceptive 
methods. 

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Section Number & Title 
Description of Change 
Brief Rationale 
5.1.3 Recovery Period 
6.1.2, Inclusion Criteria for 
Maintenance Treatment 
1. Removed last sentence in the first 
paragraph in 5.1.3. 
2. Removed Inclusion Criterion 4) 
a). 
3. Updated Inclusion Criterion 4) b). 
4. Updated Inclusion Criterion 4) d). 
1. Removed disease 
progression as assessed by 
investigator to keep 
consistent with updates in 
Inclusion Criterion 4) b) in 
Section 6.1.2. 
2. Removed to eliminate 
potential eligibility barriers 
into the maintenance period 
and allow for investigator’s 
discretion. 
3. Clarified that absence of 
progressive disease must be 
confirmed by BICR. 
4. Esophagitis added to be 
consistent with guidance in 
other section of protocol. 
Additional text added to 
provide flexibility for 
inclusion of participants in 
maintenance treatment. 
6.2.1, Exclusion Criteria for CCRT 
7.7.1, Prohibited and/or Restricted 
Treatments 
1. Updated Exclusion Criterion 1) 
c). 
2. Added Exclusion Criterion 1) n). 
3. Updated botanical preparations to 
complementary medications in 
Exclusion Criterion 2) d) and in 
Section 7.7.1. 
4. Updated Exclusion Criterion 2) 
a). 
5. Added Exclusion Criterion 2, g). 
6. Updated Exclusion Criterion 3) i). 
1. Updated criterion to 
eliminate potential 
unnecessary enrollment 
barriers. 
2. Added exclusion for 
participants with SARS- 
CoV-2 infection within 4 
weeks of screening to avoid 
placing participants at 
higher risk of adverse events 
when receiving study 
treatment. 
3. To prohibit both botanical 
and nonbotanical 
preparations used to treat 
the disease under study or as 
supportive care. 
4. Clarified exceptions for 
prior thoracic therapy to 
address enrollment barrier. 
5. Added criterion for 
prior/current treatment in 
interventional trials. 
6. Updated to emphasize that 
both FEV1 and DLCO is 
required for eligibility. 

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Section Number & Title 
Description of Change 
Brief Rationale 
6.2.2, Exclusion Criteria for 
Maintenance 
Added text for delay between 
recovery and maintenance period. 
Clarified eligibility/procedure if 
recovery period is delayed. 
6.4.1, Retesting During Screening 
Period 
Added text addressing re-enrollment 
and participant number. 
Clarified that re-enrolled 
participants should receive a new 
participant number. 
7, TREATMENT; Table 7-1 
1. Added additional row and 
footnote a (this caused the prior 
footnotes to become b and c) and 
updated footnote c. 
2. Added a note indicating that 
radiotherapy is not considered 
study treatment. 
1. 50 mg ipilimumab vial 
presentation will be 
available starting Q3 2022 
and 200 mg vials are being 
phased out. 
Footnote c change from 
Administrative Letter 03. 
2. To clarify that radiotherapy 
is background treatment. 
7.1.1, Nivolumab Dosing 
Updated text to include 
“approximately” before infusion time. 
Added text for flushing the IV line, 
order of infusion, and reminder to 
assure sterility of prepared solution. 
Added instruction to ensure full 
delivery of nivolumab dose. 
Clarified order of administration 
of study treatment when used in 
combination. Added additional 
details for the safe storage, 
preparation, and administration 
of nivolumab. 
7.1.2, Ipilimumab Dosing 
Updated text to include 
“approximately” before infusion time. 
Updated text to note that dosing visits 
cannot be skipped. 
Added text to use separate infusion 
bags and filters when administering 
nivolumab and ipilimumab on the 
same day. 
Added instruction to ensure full 
delivery of nivolumab dose. 
Clarified that ipilimumab doses 
cannot be skipped. 
Added additional details for the 
safe storage, preparation, and 
administration of ipilimumab. 
7.1.4.1 , Paclitaxel/Carboplatin 
Dosing 
7.1.4.2 , Etoposide/cisplatin 
7.1.4.3 , Pemetrexed/cisplatin 
7.1.4.4 , Carboplatin Dosing (with 
Etoposide or Pemetrexed) 
Where applicable, “local label 
requirements” has been changed to 
“local standard.” 
Administrative change. 
7.1.4.2, Etoposide/cisplatin 
Deleted sentence for BSA. 
Changed to accommodate 
varying regional practice/clinical 
standards. 
7.1.5, Radiotherapy Planning and 
Delivery 
Added texted referring back to the 
Thoracic Radiotherapy Guidelines. 
Added per feedback 

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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
7.4.1.1, Criteria to Resume 
Nivolumab 
1. Added criteria to resume 
treatment. 
2. Updated sentence for adrenal 
insufficiency. 
1. Added to highlight that 
study treatment can be 
resumed after AE 
management is complete. 
2. Administrative change. 
7.4.5, Chemotherapy Dose Delay, 
Dose Modification, and Criteria to 
Resume Treatment 
Added text that modifications of 
chemotherapy dose should follow 
approved product labeling in addition 
to local institutional standards. 
Changed to accommodate local 
labeling and clinical standards 
for the safe dosing and 
administration of chemotherapy. 
7.4.5, Chemotherapy Dose Delay, 
Dose Modification, and Criteria to 
Resume Treatment 
7.7.1, Prohibited and/or Restricted 
Treatments 
Added text for administration of 
growth colony stimulating factors 
(GCSF) for supporter measures. 
Clarified GCSFs can be 
administered and should only be 
used to support hematologic 
recovery. 
7.4.5.7, Dose Modifications for 
Toxicities with Carboplatin + 
Paclitaxel Regimen 
Qualified statement that there are no 
dose reductions. 
Changed to accommodate 
varying regional practice/clinical 
standards. 
8.1, Discontinuation from Study 
Treatment 
Text updated to say that 
discontinuation must be document in 
the participant’s medical records per 
local regulatory requirements in each 
region/country. 
Changed to accommodate 
varying regional practice/clinical 
standards. 
8.1.4, Discontinuation Criteria for 
Chemoradiotherapy 
In the fifth bullet, the dose reduction 
for etoposide was changed to 25% 
when substituting for pemetrexed. 
Corrected typo from Revised 
Protocol 01. 
9.1.1, Imaging Assessment for the 
Study 
Changed “will” to “must.” 
Expanded language for scans done at 
other time points. 
Text changed for emphasis. 
Expanded language specifically 
calls out scans at unscheduled 
time points and outside 
institutions. 
9.1.2, Outcomes Research 
Assessments 
Added text indicating measures should 
be entered into the CRF and allowing 
alternative administration methods if 
needed. 
Clarified recording of PRO 
measures in long-term follow-up 
period. 
Added flexibility to data 
collection if circumstances 
require alternative methods of 
collection. 
9.2.1, Time Period and Frequency 
for Collecting AE and SAE 
Information 
Removed first sentence about location 
of Reference Safety Information in IB. 
Added text for collection of non- 
serious adverse events (AEs) and 
serious adverse events (SAEs) for 
randomized but never-treated 
participants. 
Sentence no longer reflects the 
appropriate location in the IB for 
Reference Safety Information. 
Updated section to reflect all the 
AE information to be collected 
and the collection timing. 

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Section Number & Title 
9.2.2, Method of Detecting AEs and 
SAEs 
 
9.5, Pharmacokinetics; Table 9.5-1 
to Table 9.5-4 
 
 
9.8, Biomarkers; Table 9.8-1 to 
Description of Change 
Added text for assessment/collection 
of immune-mediated AEs. 
 
Updated footnote a and b. 
Brief Rationale 
Updated instructions for 
collection of safety data (adverse 
events). 
Clarified definition of end of 
infusion-PK and need for full 
infusion of study treatment prior 
to sample collection. 
 
2. Updated based on local 
country-specific restrictions. 
 
 
9.8 Biomarkers; Table 9.8-1 
2. 
Updated footnote a. 
Added footnote d. 
 
9.8 , Biomarkers; 
 
9.8.1 , Tumor Tissue Specimens 
 
 
Added text that specifies there should 
be no intervening therapy between 
tumor sample collection and 
randomization and for possible uses 
for screening and progression tumor 
samples. 
Removed based on the 
biomarker requirement review. 
Added for clarity. 
 
 
 
 
 
 
 
Administrative change. 

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Section Number & Title 
Description of Change 
Brief Rationale 
Updated for clarity. 
10.3 , Statistical Analyses 
10.3.1 , Efficacy Analyses 
1. Added general text for summary 
of continuous and categorical 
data. 
2. Updated analyses description for 
PFS, TTR/DoR, investigator- 
assessed efficacy endpoints, 
TTDM, PFS-2, and patient- 
reported outcomes. 
1. Made text more general to 
cover all the data being 
collected and not just the 
PFS and OS data described 
previously. 
2. Clarified the statistical 
analysis methods used and 
aligned definition of 
primary PFS analysis with 
that in PACIFIC and per 
ITT principles in ICH E9 
(R1) addendum. This 
intends to mitigate the 
impact of non- 
administrative censoring 
seen in external NSCLC 
trials, which was not 
previously accounted for in 
the CA20973L analysis 
plan. 
10.1.1, Sample Size Justification for 
PFS 
Updated PFS assumptions of control 
arm. 
To incorporate most recent 
PACIFIC and PROCLAIM 
updated PFS assumptions for the 
control arm. 
10.1.2, Sample Size Justification for 
OS 
 
Added additional OS interims based 
on timing of PFS interims. 
OS assumptions and timing of 
analyses are adjusted following 
updated PFS. 

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CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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SUMMARY OF KEY CHANGES FOR PROTOCOL AMENDMENT 02 
Section Number & Title 
Description of Change 
Brief Rationale 
10.3.3, Other Analyses 
Reordered first sentence and indicated 
when information in the Statistical 
Analysis Plan will be finalized. 
Updated text to clarify that all 
the analyses listed in this section 
are exploratory and that the 
analysis plan will be finalized at 
database lock and unblinding. 
10.3.4, Interim Analyses 
Updated text to make a tabular 
schedule for interim analyses based on 
updated assumptions outlined in 
Section 10.1. 
Updated PFS and OS 
assumptions. 
Appendix 2 
Updated language under Monitoring 
subsection. 
Added Dissemination of Clinical 
Study Data subsection. 
To allow alternative monitoring 
in circumstances where on-site 
monitoring is not advised. 
Appendix 6 
Minor noncontent-related update to 
the approval date on the management 
algorithms (lower right corner). 
Updated to reflect their inclusion 
in nivolumab IB addendum 01 
Appendix 9 
Updated the applicable countries. 
Removed Spain as mandatory 
HIV test at screening is no more 
applicable in Spain. 
Removed Czech Republic as it 
has not participated in the trial. 

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CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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Overall rationale for Revised Protocol 01, 04-Mar-2020 
 
 
 
 
 
 
SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Synopsis 
Section 4 Objectives and Endpoints 
Updated language for objectives and 
endpoints 
Description of objectives 
updated to more succinctly 
characterize comparisons of 
different treatment arms and 
overall study endpoints 
Synopsis 
Section 5 Study Design 
Section 7.2 Method of Treatment 
Assignment 
Revised PD-L1 stratification to 
include 3 separate PD-L1 
stratification: ≥1%, <1%, and 
indeterminate or not evaluable 
Update made based on 
feedback 
Table 2-1 Screening 
Section 5.1.1 Screening Period 
Instructions added for lymph node 
sampling for cT4 disease and 
PET/CT body imaging. 
Additional instructions 
provide clarity for data 
collection. 
Synopsis 
Table 2-2 CCRT Period Cisplatin (or 
Carboplatin) + Etoposide or Pemetrexed 
Section 5.1 Overall Design 
Section 5.1.2 CCRT Period 
Section 7.1.5 Radiotherapy Planning and 
Delivery 
Instructions added for participants 
who skip Cycle 1 of CCRT compared 
to participants who receive Cycle 1 
therapy. 
Additional instructions 
provide clarity for data 
collection. 
Synopsis 
Table 2-2 CCRT Period Cisplatin (or 
Carboplatin) + Etoposide or Pemetrexed 
Table 2-3 CCRT Period Carboplatin and 
Paclitaxel 
Section 5.1.2 CCRT Period 
Table 7-1 Study treatments for 
CA20973L 
Section 7.1.4 Chemotherapy Dosing 
Section 7.4.5 Chemotherapy Dose 
Delay, Dose Modification, and Criteria 
to Resume Treatment 
Section 7.4.5.5 Dose Modifications for 
Toxicities with Carboplatin + Paclitaxel 
Regimen 
Table 7.4.5.5-1 Carboplatin + Paclitaxel 
Dose Modifications for Hematological 
Toxicities 
Additional chemotherapy regimen 
(carboplatin + paclitaxel) and table 
added 
Instructions added for chemotherapy 
pre-specification and administration 
Carboplatin + paclitaxel 
regimen added to align 
treatment options in the trial 
with global standard of care. 
Additional instructions 
provide clarity for treatment 
pre-specification, 
administration and data 
collection. 
Table 2-2 Concurrent CCRT Period 
Cisplatin (or Carboplatin) + Etoposide 
or Pemetrexed 
Instructions added for timing and 
coordination of radiotherapy 
Additional instructions 
provide clarity for data 
collection. 

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CA20973L 
nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 3.2.3 Clinical Experience with 
Nivolumab plus Ipilimumab 
Combination Therapy 
Section 3.2.4 Clinical Experience with 
Nivolumab and CCRT 
Section 5.4.1 Rationale for Study 
Population and Study Comparator 
Section 5.4.4 Rationale of Concurrent 
Scheduling of Nivolumab with CCRT 
Section 5.4.6 Rationale of Backbone 
CCRT 
Updated clinical background of 
ongoing clinical studies using same 
drug treatments and/or CCRT. 
Additional information 
provide clarity to characterize 
risk/benefit of study. 
Section 6.1 Study Population Inclusion 
Criteria 
Inclusion criteria was updated to 
include: 
• 
Participant’s legal authorized 
representative may sign the 
approved ICF on behalf of 
participant 
• 
Participants must be evaluated 
by the site’s multidisciplinary 
team (eg, medical oncologist, 
surgeon, radiologist) during 
screening to assess the suitability 
of the participant for the study. 
• 
Adherence to local product label 
contraception requirements for 
chemotherapy 
request 
Given the multidisciplinary 
nature of treating patients 
with stage III NSCLC, 
evaluating the suitability of a 
participant for the trial within 
the multidisciplinary team 
ensures that the study is in 
the best interest of the 
participant 
request to 
account for labeling of 
chemotherapy agents 
To provide flexibility for 
clinical discretion of the 
Investigator 

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nivolumab 
Protocol Amendment No.: 03 
Date: 30-Oct-2023 
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SUMMARY OF KEY CHANGES FOR REVISED PROTOCOL 01 
Section Number & Title 
Description of Change 
Brief Rationale 
Section 6.2 Study Population Exclusion 
Criteria for Maintenance 
Radiotherapy dose constraints 
relaxed for eligibility purposes 
Exclusion criteria was updated for 
hearing loss, neuropathy 
Participants with myelosuppression 
may be allowed to proceed with 
maintenance therapy at the 
investigator’s discretion 
Radiotherapy planning may 
not be complete at time of 
eligibility assessment during 
Screening. Radiotherapy dose 
constraints are now specified 
in the separate radiotherapy 
guidelines document 
Criteria for hearing loss and 
neuropathy will adhere to 
local product label. 
Following CCRT, it may take 
longer than 42 days for 
hematological values to 
recover, while a participant is 
in suitable health to continue 
with maintenance IO therapy. 
Flexibility permitted per 
investigator’s clinical 
judgement of hematological 
values. 
Section 7.4.4.1 Management Algorithms 
for Ipilimumab, Nivolumab, or 
Durvalumab 
Updated algorithms for myocarditis 
Updated algorithms for 
myocarditis 
Table 9.4.4-1 Clinical Safety Laboratory 
Assessments 
Removed amylase and lipase 
collection 
Align clinical laboratory 
assessments with nivolumab 
program standards 
Table 9.5-1 Pharmacokinetic and 
Immunogenicity Sampling in Arm A 
(CCRT) 
Table 9.5-3 Pharmacokinetic and 
Immunogenicity Sampling in Arm B 
(CCRT) 
Cycle 2 Day 1 EOI sampling added 
Allows for consistency in PK 
and IMG sample collection 
for participants who initiate 
treatment at Cycle 1 of 
CCRT and participants who 
initiate treatment at Cycle 2 
All 
Minor formatting and typographical 
corrections 
Minor, therefore have not 
been summarized