A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
Phase: PHASE3
Conditions: Metastatic Squamous Non-Small Cell Lung Cancer, Metastatic Nonsquamous Non-Small Cell Lung Cancer
Sponsor: Incyte Corporation

NCT Number: 
Document Date: 
A Randomized, Double Blind, Phase 3 Study of Platinum-
Based Chemotherapy With or Without INCMGA00012 in 
First-Line Metastatic Squamous and Nonsquamous Non–
Small Cell Lung Cancer (POD1UM-304) 
 NCT04205812
Protocol Amendment Version 3: 18 October 2022 
Official Title: 

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Protocol INCMGA 0012-304 Am 3 
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TITLE PAGE 
Clinical Study Protocol 
INCMGA 0012-304 
A Randomized, Double Blind, Phase 3 Study of Platinum-Based 
Chemotherapy With or Without INCMGA00012 in First-Line Metastatic 
Squamous and Nonsquamous Non–Small Cell Lung Cancer 
(POD1UM-304) 
Product: 
INCMGA00012 
IND Number: 
141,702 
EudraCT Number: 
2019-003372-39 
EU CT Number: 
2022-501987-16-00 
Phase of Study: 
3 
Global Sponsor: 
Incyte Corporation 
1801 Augustine Cut-Off 
Wilmington, DE 19803 
Original Protocol: 
14 NOV 2019 
Amendment 1: 
16 DEC 2021 
Amendment 2: 
16 MAY 2022 
Amendment 3: 
18 OCT 2022 
Execution of the Study in China: 
 
 
 
 China 
This study will be performed in accordance with ethical principles that have their origin in the Declaration of 
Helsinki and conducted in adherence to the study Protocol, applicable Good Clinical Practices, and applicable laws 
and country-specific regulations in which the study is being conducted.  The research in the Netherlands is carried 
out in accordance with the Declaration of Helsinki (Brazil, 2013) and the WMO (Medical Research Involving 
Human Participants Act). 
The information in this document is confidential.  No part of this information may be duplicated, referenced, or 
transmitted in any form or by any means (electronic, mechanical, photocopy, recording, or otherwise) without prior 
written consent. 

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INVESTIGATOR'S AGREEMENT 
I have read the INCMGA 0012-304 Protocol Amendment 3 dated 18 OCT 2022 and agree to 
conduct the study as outlined.  I agree to maintain the confidentiality of all information received 
or developed in connection with this Protocol. 
(Printed Name of Investigator) 
(Signature of Investigator) 
(Date) 

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TABLE OF CONTENTS 
TITLE PAGE ...................................................................................................................................1 
INVESTIGATOR'S AGREEMENT ................................................................................................2 
TABLE OF CONTENTS .................................................................................................................3 
LIST OF ABBREVIATIONS ........................................................................................................10 
1. 
PROTOCOL SUMMARY ..........................................................................................14 
2. 
INTRODUCTION ......................................................................................................32 
2.1. 
Background .................................................................................................................32 
2.1.1. 
Metastatic Non–Small Cell Lung Cancer ...................................................................32 
2.1.2. 
INCMGA00012 ..........................................................................................................33 
2.2. 
Study Rationale ...........................................................................................................35 
2.2.1. 
Rationale for Study Design .........................................................................................35 
2.2.2. 
Scientific Rationale for Study Design ........................................................................35 
2.2.3. 
Justification for INCMGA00012 Dose .......................................................................35 
2.2.4. 
Rationale for the Use of Placebo ................................................................................36 
2.2.5. 
Benefit/Risk Assessment ............................................................................................36 
2.2.5.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic ......................................38 
3. 
OBJECTIVES AND ENDPOINTS ............................................................................40 
4. 
STUDY DESIGN .......................................................................................................41 
4.1. 
Overall Design ............................................................................................................41 
4.2. 
Number of Participants ...............................................................................................42 
4.3. 
Overall Study Duration ...............................................................................................42 
4.4. 
Study Termination ......................................................................................................43 
5. 
STUDY POPULATION .............................................................................................44 
5.1. 
Inclusion Criteria ........................................................................................................44 
5.2. 
Exclusion Criteria .......................................................................................................47 
5.3. 
Lifestyle Considerations .............................................................................................49 
5.3.1. 
Meals and Dietary Restrictions ...................................................................................49 
5.3.2. 
Use in Nursing Women ..............................................................................................49 
5.3.3. 
Use in Pregnancy ........................................................................................................50 
5.4. 
Screen Failures ............................................................................................................50 
5.5. 
External Data Monitoring Committee ........................................................................50 

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5.6. 
Replacement of Participants .......................................................................................50 
6. 
STUDY TREATMENT ..............................................................................................51 
6.1. 
Study Treatments Administered .................................................................................51 
6.1.1. 
Timing of Dose Administration ..................................................................................53 
6.1.1.1. 
INCMGA00012/Placebo ............................................................................................53 
6.1.2. 
For Participants With Nonsquamous Non–Small Cell Lung Cancer .........................53 
6.1.2.1. 
Carboplatin .................................................................................................................53 
6.1.2.2. 
Cisplatin ......................................................................................................................54 
6.1.2.3. 
Pemetrexed .................................................................................................................54 
6.1.3. 
For Participants With Squamous Non–Small Cell Lung Cancer ................................54 
6.1.3.1. 
Paclitaxel .....................................................................................................................54 
6.1.3.2. 
Nab-Paclitaxel .............................................................................................................54 
6.1.3.3. 
Carboplatin .................................................................................................................55 
6.1.3.4. 
Antiemetic Therapy for Nonsquamous Non–Small Cell Lung Cancer ......................55 
6.2. 
Preparation, Handling, and Accountability ................................................................55 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding .......................................56 
6.4. 
Study Treatment Compliance .....................................................................................56 
6.5. 
Dose Modifications .....................................................................................................56 
6.5.1. 
Dose Modifications for Immune-Related Toxicity.....................................................56 
6.5.1.1. 
Guidelines for Management of Suspected Infusion Reactions ...................................62 
6.5.2. 
Dose Modifications for Nonimmune (Chemotherapy-Related) Toxicity ...................63 
6.5.2.1. 
Chemotherapy Dose Modification for Hematological and Nonhematological 
Toxicities ....................................................................................................................63 
6.5.2.2. 
Modifications Due to Creatinine Clearance ...............................................................66 
6.5.3. 
Criteria for Permanent Discontinuation of Study Drug ..............................................66 
6.6. 
Concomitant Medications and Procedures .................................................................67 
6.6.1. 
Permitted Medications and Procedures ......................................................................67 
6.6.2. 
Restricted Medications and Procedures ......................................................................68 
6.6.3. 
Prohibited Medications and Procedures .....................................................................69 
6.7. 
Crossover Study Drug Treatment and Criteria ...........................................................70 
6.8. 
Treatment After the End of the Study .........................................................................71 
7. 
DISCONTINUATION OF STUDY TREATMENT AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................72 

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7.1. 
Discontinuation of Study Treatment ...........................................................................72 
7.1.1. 
Reasons for Discontinuation .......................................................................................72 
7.1.2. 
Discontinuation Procedures ........................................................................................73 
7.2. 
Participant Withdrawal From the Study .....................................................................74 
7.3. 
Lost to Follow-Up.......................................................................................................74 
8. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................75 
8.1. 
Administrative and General Procedures .....................................................................75 
8.1.1. 
Informed Consent Process ..........................................................................................75 
8.1.2. 
Screening Procedures ..................................................................................................76 
8.1.3. 
Interactive Response Technology Procedure ..............................................................77 
8.1.4. 
Assignment of Treatment/Randomization Number ....................................................77 
8.1.5. 
Distribution of Reminder Cards ..................................................................................77 
8.1.6. 
COVID-19 ..................................................................................................................77 
8.1.7. 
Demography and Medical History ..............................................................................78 
8.1.7.1. 
Demographics and General Medical History .............................................................78 
8.1.7.2. 
Disease Characteristics and Treatment History ..........................................................78 
8.1.8. 
Prior and Concomitant Medications Review ..............................................................78 
8.1.8.1. 
Prior Medications ........................................................................................................78 
8.1.8.2. 
Concomitant Medications ...........................................................................................78 
8.2. 
Treatment Administration ...........................................................................................78 
8.2.1. 
Timing of Dose Administration ..................................................................................79 
8.3. 
Efficacy Assessments .................................................................................................79 
8.3.1. 
Tumor Imaging and Assessment of Disease ...............................................................79 
8.3.2. 
Initial Tumor Imaging .................................................................................................80 
8.3.3. 
Tumor Imaging During the Study...............................................................................80 
8.3.4. 
End of Study Treatment and Follow-Up of Tumor Imaging ......................................81 
8.3.5. 
Crossover Tumor Imaging ..........................................................................................81 
8.3.6. 
RECIST Version 1.1 Assessment of Disease .............................................................82 
8.3.7. 
iRECIST Assessment of Disease ................................................................................82 
8.4. 
Health Economics .......................................................................................................82 
8.5. 
Health Care Resource Utilization ...............................................................................83 
 
83 
 
83 

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8.7. 
Safety Assessments .....................................................................................................83 
8.7.1. 
Adverse Events ...........................................................................................................83 
8.7.2. 
Physical Examinations ................................................................................................84 
8.7.3. 
Vital Signs ..................................................................................................................85 
8.7.4. 
Electrocardiograms .....................................................................................................85 
8.7.5. 
Eastern Cooperative Oncology Group Performance Status ........................................85 
8.7.6. 
Laboratory Assessments .............................................................................................85 
8.7.7. 
Pregnancy Testing ......................................................................................................87 
8.8. 
Pharmacokinetic 
 Assessments ..................................................87 
 
88 
8.9. 
88 
8.9.1. 
Tumor Tissue Biopsies ...............................................................................................89 
8.10. 
Unscheduled Visits .....................................................................................................89 
8.11. 
End of Treatment and/or Early Termination ..............................................................90 
8.12. 
Follow-Up ...................................................................................................................90 
8.12.1. 
Safety Follow-Up ........................................................................................................90 
8.12.2. 
Post-Treatment Disease Follow-Up ............................................................................91 
8.12.3. 
Survival Follow-Up ....................................................................................................91 
 
 
92 
8.12.4. 
Survival Status Monitoring .........................................................................................92 
8.13. 
Crossover Period .........................................................................................................92 
9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING ......................93 
9.1. 
Definition of Adverse Event .......................................................................................93 
9.2. 
Definition of Serious Adverse Event ..........................................................................94 
9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse Events .........95 
9.4. 
Reporting of Serious Adverse Events .........................................................................97 
9.5. 
Adverse Events of Special Interest .............................................................................98 
9.6. 
Emergency Unblinding of Treatment Assignment .....................................................99 
9.7. 
Pregnancy ...................................................................................................................99 
9.8. 
Warnings and Precautions ........................................................................................100 

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9.9. 
Product Complaints ..................................................................................................100 
9.10. 
Treatment of Overdose .............................................................................................100 
10. 
STATISTICS ............................................................................................................101 
10.1. 
Sample Size Determination ......................................................................................101 
10.2. 
Populations for Analysis ...........................................................................................101 
10.3. 
Level of Significance ................................................................................................102 
10.4. 
Statistical Analyses ...................................................................................................102 
10.4.1. 
Primary Analysis ......................................................................................................103 
10.4.2. 
Subgroup Analyses ...................................................................................................103 
10.4.3. 
Secondary Analyses ..................................................................................................104 
10.4.3.1. 
Progression-Free Survival ........................................................................................104 
10.4.3.2. 
Objective Response Rate ..........................................................................................105 
10.4.3.3. 
Duration of Response ...............................................................................................105 
10.4.4. 
Safety Analyses ........................................................................................................105 
10.4.4.1. 
Adverse Events .........................................................................................................106 
10.4.4.2. 
Clinical Laboratory Tests .........................................................................................106 
10.4.4.3. 
Vital Signs ................................................................................................................106 
10.4.4.4. 
Electrocardiograms ...................................................................................................106 
10.4.4.5. 
Dose Exposure ..........................................................................................................107 
10.4.4.6. 
Pharmacokinetics ......................................................................................................107 
 
107 
 
107 
 
107 
 
107 
 
108 
10.5. 
Interim Analysis ........................................................................................................108 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ................................................................................................110 
11.1. 
Investigator Responsibilities .....................................................................................110 
11.1.1. 
Identification of the Coordinating Principal Investigator .........................................111 
11.2. 
Data Management .....................................................................................................111 
11.3. 
Data Quality Assurance ............................................................................................113 
11.4. 
Data Privacy and Confidentiality of Study Records .................................................113 

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11.5. 
Financial Disclosure .................................................................................................114 
11.6. 
Publication Policy .....................................................................................................115 
11.7. 
Compliance With Trial Registration and Results Posting Requirements .................115 
11.8. 
Study and Site Closure..............................................................................................115 
12. 
REFERENCES .........................................................................................................117 
APPENDIX A. IMPORTANT INFORMATION REGARDING EFFECTIVENESS 
OF CONTRACEPTIVE METHODS .......................................................................122 
APPENDIX B. MASCC/ESMO ANTIEMETIC GUIDELINES .............................................124 
APPENDIX C. CALCULATED CREATININE CLEARANCE .............................................125 
APPENDIX D. CLINICAL LOCAL LABORATORY TESTS ...............................................126 
APPENDIX E. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS .....................................................................................127 
APPENDIX F. TREATMENT AND IMAGING AFTER EVIDENCE OF 
PROGRESSIVE DISEASE WITH IRECIST ..........................................................128 
APPENDIX G. COVID-19 PANDEMIC GUIDANCE ...........................................................130 
APPENDIX H. PROTOCOL AMENDMENT SUMMARY OF CHANGES .........................134 
 

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LIST OF TABLES 
Table 1: 
Primary and Secondary Objectives and Endpoints .....................................................14 
Table 2: 
Key Study Design Elements .......................................................................................15 
Table 3: 
Schedule of Activities for Participants With Nonsquamous Non–Small Cell 
Lung Cancer ................................................................................................................19 
Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell 
Lung Cancer ................................................................................................................23 
Table 5: 
Crossover Period Schedule of Activities ....................................................................28 
Table 6: 
Objectives and Endpoints ...........................................................................................40 
Table 7: 
Adequate Organ Function Laboratory Values ............................................................46 
Table 8: 
Study Drug and Treatment Information .....................................................................52 
Table 9: 
Dose Modifications for Adverse Events of INCMGA00012/Placebo and 
Toxicity Management Guidelines for Immune-Related Adverse Events ...................58 
Table 10: Guidelines for Management of Suspected Infusion Reactions ...................................62 
Table 11: Dose Levels for Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, and 
Carboplatin .................................................................................................................63 
Table 12: Recommended Dose Modifications of Pemetrexed, Cisplatin, and 
Carboplatin Chemotherapy Agents for Hematological Toxicity ................................64 
Table 13: Recommended Dose Modifications of Pemetrexed, Cisplatin, and 
Carboplatin Chemotherapy Agents for Nonhematological Toxicity ..........................64 
Table 14: Dose Reductions for Hematologic Adverse Drug Reactions for 
Nab-Paclitaxel .............................................................................................................65 
Table 15: Dose Reductions for Nonhematologic Toxicities for Nab-Paclitaxel ........................65 
Table 16: Pharmacokinetic 
 Blood (Serum) Sample Timing ......................................88 
Table 17: Populations for Analysis ...........................................................................................102 
Table 18: Evaluation and Censoring of Progression-Free Survival ..........................................104 
Table 19: Evaluation and Censoring of Duration of Response .................................................105 
Table 20: Guidelines for Decisions in Overall Survival Endpoint ...........................................109 
 
LIST OF FIGURES 
Figure 1: 
Study Design Schemas ...............................................................................................17 
 

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LIST OF ABBREVIATIONS 
Abbreviations and 
Special Terms 
Definition 
AACR 
American Association of Cancer Research 
ABCP 
atezolizumab plus bevacizumab plus carboplatin plus paclitaxel 
 
 
AE 
adverse event 
AJCC 
American Joint Committee on Cancer 
ALK 
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase 
ANC 
absolute neutrophil count 
aPTT 
activated partial thromboplastin time 
ASCO 
American Society of Clinical Oncology 
AST 
aspartate aminotransferase 
AUC 
area under the plasma or serum concentration curve 
AUC0-∞ 
area under the single-dose plasma or serum concentration-time curve 
extrapolated to time of infinity 
BCG 
Bacillus Calmette-Guérin 
BCP 
bevacizumab plus carboplatin plus paclitaxel 
BICR 
blinded independent central review 
BID 
twice daily 
BRAF 
B-Raf proto-oncogene, serine/threonine kinase 
CI 
confidence interval 
CFR 
Code of Federal Regulations 
Cmax 
maximum observed plasma or serum concentration 
Cmin  
minimum observed plasma or serum concentration over the dose interval 
Cmin,ss  
minimum observed plasma or serum concentration at steady state 
COVID-19 
coronavirus disease 2019 
CNS 
central nervous system 
CR 
complete response  
CrCl 
creatinine clearance 
CRF 
case report form 
CSR 
Clinical Study Report 
CT 
computed tomography  
CTCAE 
Common Terminology Criteria for Adverse Events 
CYP 
cytochrome P450 
D1 
Day 1 

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Abbreviations and 
Special Terms 
Definition 
DILI 
drug-induced liver injury 
DL 
dose level 
DNA 
deoxyribonucleic acid 
DOR 
duration of response 
EC 
ethics committee 
ECG 
electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eDMC 
external Data Monitoring Committee  
EEA 
European Economic Area 
EGFR 
epidermal growth factor receptor 
EMA 
European Medicines Agency 
 
 
 
 
 
 
EOT 
end of treatment 
ESMO 
European Society for Medical Oncology 
EU 
European Union 
FAS 
full analysis set 
Fc 
fragment crystallizable 
FDA 
Food and Drug Administration 
FSH 
follicle stimulating hormone  
FT3 
Free triiodothyronine 
FT4 
Free thyroxine  
g 
grams 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
GFR 
glomerular filtration rate 
Gy 
gray 
HBsAg 
hepatitis B surface antigen 
HBV 
hepatitis B virus 
HCV 
hepatitis C virus 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HIV 
human immunodeficiency virus 

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Abbreviations and 
Special Terms 
Definition 
HR 
hazard ratio 
HRT 
hormone replacement therapy 
IB 
Investigator's Brochure 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation of Technical Requirements for 
Registration of Pharmaceuticals for Human Use 
iCPD 
confirmed progressive disease per iRECIST 
iCR 
complete response per iRECIST 
IEC 
independent ethics committee 
IgG4 
immunoglobulin G4 
ILD 
interstitial lung disease 
INR 
international normalized ratio 
iPD 
progressive disease per iRECIST 
irAE 
immune-related adverse event 
IRB 
institutional review board 
iRECIST 
modified RECIST v1.1 for immune-based therapies 
IRR 
infusion-related reaction 
IRT 
interactive response technology 
iSD 
stable disease per iRECIST 
ITT 
intent-to-treat 
iUPD 
unconfirmed progressive disease per iRECIST 
IV 
intravenous(ly) 
IVRS 
interactive voice response system 
MASCC 
Multinational Association of Supportive Care in Cancer 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
magnetic resonance imaging 
MTD 
maximum tolerated dose 
NCCN 
National Comprehensive Cancer Network 
NCI 
National Cancer Institute 
NE 
not evaluable 
NSAID 
nonsteroidal anti-inflammatory drugs 
NSCLC 
non–small cell lung cancer 
ORR 
objective response rate 
OS 
overall survival 
PCR 
polymerase chain reaction 
PD 
progressive disease 

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Abbreviations and 
Special Terms 
Definition 
PD-1 
programmed cell death protein 1 
PD-L1 
programmed cell death ligand 1 
PET 
positron emission tomography  
PFS 
progression-free survival 
 
 
PK 
pharmacokinetic 
PPS 
per Protocol set 
PR 
partial response 
PRO 
patient-reported outcome 
PT 
prothrombin time 
PTT 
partial thromboplastin time 
QXW 
every X weeks 
RECIST v1.1 
Response Evaluation Criteria in Solid Tumors version 1.1 
RNA 
ribonucleic acid 
ROS1 
receptor tyrosine kinase (encoded by the gene ROS1) 
RT-PCR 
reverse transcription-polymerase chain reaction 
SAE 
serious adverse event 
SAP 
Statistical Analysis Plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SITC 
Society for Immunotherapy of Cancer 
SJS 
Stevens-Johnson syndrome 
SoA 
schedule of activities 
SGOT 
serum glutamic oxaloacetic transaminase 
SGPT 
serum glutamic-pyruvic transaminase 
SOC 
standard of care 
Study drug 
INCMGA00012/placebo 
Study treatment 
INCMGA00012/placebo plus chemotherapy 
t½ 
apparent terminal-phase disposition half-life 
T3 
free or total triiodothyronine 
TEAE 
treatment-emergent adverse event 
TEN 
toxic epidermal necrolysis 
TPS 
tumor proportion score 
TSH 
thyroid-stimulating hormone 
ULN 
upper limit of normal 
WBC 
white blood cell 
WOCBP 
women of childbearing potential 

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1. 
PROTOCOL SUMMARY 
This is a randomized, double-blind, study of IV INCMGA00012 or placebo combined with 
platinum-based chemotherapy in participants with metastatic nonsquamous or squamous NSCLC 
who have not previously received systemic therapy for advanced disease and who do not have 
sensitizing driver mutations or gene rearrangements of EGFR, ALK, BRAF, or ROS1. 
Protocol Title: A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy 
With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous 
Non-Small Cell Lung Cancer (POD1UM-304) 
Protocol Number:  INCMGA 0012-304 
Objectives and Endpoints: 
Table 1 presents the primary and secondary objectives and endpoints. 
Table 1: 
Primary and Secondary Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the OS of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
OS, defined as the time from randomization until 
death due to any cause. 
Secondary 
To compare the PFS of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
PFS, defined as the time from randomization until 
disease progression by RECIST v1.1 as determined 
by BICR or death due to any cause. 
To compare ORR of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
ORR, defined as the proportion of participants who 
have a confirmed CR or PR per RECIST v1.1 
based on BICR. 
To compare DOR of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
DOR defined as the time from the earliest date of 
documented response until earliest date of disease 
progression or death from any cause, whichever 
comes first, per RECIST v1.1 based on BICR. 
To evaluate the safety and tolerability of the 
combination of INCMGA00012 and 
chemotherapy and the combination of placebo 
and chemotherapy. 
Number of participants experiencing AEs and 
number of participants discontinuing study drug 
due to AEs. 
To evaluate the PK of INCMGA00012 375 mg 
Q3W when administered with chemotherapy. 
Population PK parameters (including Cmax, AUC) 
will be summarized. 
Overall Design: 
Table 2 presents the key study design elements.  Further study details are presented after the 
table. 

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Table 2: 
Key Study Design Elements 
Study Phase 
Phase 3 
Clinical Indication 
Treatment of metastatic NSCLC, first line 
Population 
Male and female participants at least 18 years of age (or as per adult age 
applicable per local country requirements) who have metastatic nonsquamous 
or squamous NSCLC.  Male and female participants who have not previously 
received systemic therapy for advanced disease and do not have sensitizing 
driver mutations or gene rearrangements of EGFR, ALK, BRAF, or ROS1. 
Participants who received adjuvant/neoadjuvant therapy are permitted onto the 
study as long as therapy was completed at least 12 months before the diagnosis 
of metastatic disease. 
Number of 
Participants 
Approximately 600 participants will be enrolled. 
Study Design 
This is a global, randomized, double-blind, study of IV INCMGA00012 or 
placebo combined with platinum-based chemotherapy in participants with 
metastatic nonsquamous or squamous NSCLC who have not previously 
received systemic therapy for advanced disease and who do not have 
sensitizing driver mutations or gene rearrangements of EGFR, ALK, BRAF, or 
ROS1.  The primary endpoint is OS.  INCMGA00012 or placebo will be 
administered for approximately 2 years (35 cycles) along with a standard of 
care chemotherapy regimen.  Participants assigned to placebo and 
chemotherapy will have the option of receiving open-label monotherapy 
INCMGA00012 in the crossover period following BICR documentation of PD. 
Randomization will be stratified by PD-L1 TPS score (ie, < 1%, ≥ 1% to 49%, 
≥ 50%), site geographic region (ie, East Asia vs non–East Asia), and 
predominant tumor histology (ie, squamous vs nonsquamous).   
Estimated Duration 
of Study 
Participation 
Each participant will join in the study from the time of a signed ICF through 
the final contact.  After a screening period of up to 28 days, eligible 
participants will receive assigned treatment on Day 1 of each 3-week dosing 
cycle.  Treatment with INCMGA00012 or placebo will continue until 
35 cycles of INCMGA00012 or placebo have been administered, documented 
disease progression, unacceptable adverse events(s), intercurrent illness that 
prevents further administration of treatment, investigator's decision to 
withdraw the participant, participant withdraws consent, pregnancy of the 
participant, noncompliance with the study treatment or procedure 
requirements, or administrative reasons.  Participants will have post-treatment 
follow-up for disease status, including radiographic imaging every 12 weeks, 
until initiating a new nonstudy cancer treatment, experiencing disease 
progression, death, withdrawing consent, or becoming lost to follow-up.  Once 
a participant has received the last dose of study drug/treatment, has disease 
progression, or starts a new anticancer therapy, the participant moves into the 
survival follow up period.  The participant should be contacted by telephone, 
email, or visit at least every 12 weeks (± 14 days) to assess for survival status 
until death, withdrawal of consent, the end of the study, or the participant is 
lost to follow-up, whichever occurs first. 

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Table 2: 
Key Study Design Elements (Continued) 
Randomization 
Ratio 
2:1 to either INCMGA00012 combined with pemetrexed and platinum-based 
chemotherapy (investigator's choice of cisplatin or carboplatin) or placebo 
combined with pemetrexed and platinum-based chemotherapy (investigator's 
choice of cisplatin or carboplatin) for nonsquamous NSCLC. 
2:1 to either INCMGA00012 combined with carboplatin plus paclitaxel OR 
nab-paclitaxel or placebo combined with carboplatin plus paclitaxel OR 
nab-paclitaxel for squamous NSCLC. 
eDMC 
Yes 
Treatment Groups and Duration: 
Approximately 600 participants with NSCLC will be randomized 2:1 to either receive 
INCMGA00012 375 mg IV Q3W or placebo along with the standard of care platinum-based 
chemotherapy regimens as per below. 
• Participants with nonsquamous NSCLC will be randomized to receive 1 of the 
following: 
− INCMGA00012 375 mg IV (D1) Q3W with pemetrexed 500 mg/m2 + cisplatin 
75 mg/m2 (D1) Q3W OR carboplatin AUC 5 (D1) Q3W for 4 cycles followed by 
INCMGA00012 375 mg IV plus pemetrexed 500 mg/m2 Q3W until progression 
− Placebo IV (D1) Q3W with pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (D1) 
Q3W OR carboplatin AUC 5 (D1) Q3W for 4 cycles followed by placebo IV plus 
pemetrexed 500 mg/m2 Q3W until progression 
• Participants with squamous NSCLC will be randomized to receive 1 of the 
following: 
− INCMGA00012 375 mg IV (D1) Q3W with carboplatin AUC 6 (D1) plus 
paclitaxel 200 mg/m2 (D1) OR nab-paclitaxel 100 mg/m2 (D1, D8, D15) Q3W for 
4 cycles followed by INCMGA00012 375 mg IV Q3W until progression 
− Placebo IV (D1) Q3W with carboplatin AUC 6 (D1) plus paclitaxel 200 mg/m2 
(D1) OR nab-paclitaxel 100 mg/m2 (D1, D8, D15) Q3W for 4 cycles followed by 
placebo IV Q3W until progression 
• Participants randomized to placebo and chemotherapy who have verification of PD 
by BICR and qualify for the crossover period will have the option to receive the 
following: 
− INCMGA00012 monotherapy 375 mg IV Q3W for approximately 2 years 
(35 cycles) 
The study design schema for nonsquamous and squamous NSCLC participants is shown in 
Figure 1. 

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Figure 1: 
Study Design Schemas 
For nonsquamous NSCLC participants 
 
For squamous NSCLC participants 
 

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Adherence to the study design requirements, including those specified in the SoA (see Table 3 
and Table 4) is essential and required for study conduct. 
The SoA in Table 5 is only applicable for participants randomized to placebo who have 
verification of PD by blinded central imaging review and qualify for crossover period (see 
Section 6.7). 

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Table 3: 
Schedule of Activities for Participants With Nonsquamous Non–Small Cell Lung Cancer 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C17 
C18 to 
C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d + 3 d of discona 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
Contact IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
General and 
NSCLC-specific 
medical history  
X 
 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
*After the safety follow-up visit, record all 
medication taken for SAEs as defined in 
Section 9.4. 
Participant 
Identification Card 
X 
 
 
 
 
 
 
 
 
 
 
After the participant is found eligible. 
Clinical procedures/assessments 
AE assessment 
(CTCAE v5) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
 
*Participants will be evaluated for AEs/SAEs from 
the consent through 90 days after the last dose of 
study drug or until 30 days if a new anticancer 
therapy was initiated.  See Section 8.7.1 and 
Section 9. 
Physical 
examination/body 
weight, height* 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Comprehensive examination at screening and safety 
follow-up; targeted examination for all other 
assessments. 
*Height at screening or before dosing on Cycle 1, 
only. 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
 
X 
 
 
ECOG performance 
status 
X* 
X** 
X 
X 
X 
X 
X 
X 
X 
X 
 
*ECOG for screening is to be performed within 
10 days before the first dose of study drug. 
**Does not have to be done if screening ECOG was 
performed within 3 days before Cycle 1. 
Discuss if 
SARS-CoV-2 
vaccination/booster is 
applicable 
X 
 
 
 
 
 
 
 
 
 
 
Vaccination is recommended but not required. See 
Section 5.1 and Appendix G.  

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Table 3: 
Schedule of Activities for Participants With Nonsquamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C17 
C18 to 
C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d + 3 d of discona 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Efficacy assessments 
Tumor imaging 
X 
 
 
X* 
 
X* 
X* 
X** 
X*** 
 
 
*First on-study image will be performed at 6 weeks 
(± 7 days) from date of randomization. Imaging 
performed to assess response every 6 weeks 
(42 ± 7 days) for 24 weeks, then every 9 weeks 
(63 ± 7 days) for the next 27 weeks, and 
subsequently every 12 weeks (84 ± 14 days) until 
PD is verified by BICR.  Imaging assessments are 
to be performed using the same imaging schedule 
regardless of dose delays. 
**Imaging performed every 12 weeks (84 days 
± 14 days) subsequently until PD. 
***If a previous scan was obtained within 4 weeks 
before the date of discontinuation, then a scan at 
EOT is not mandatory. 
Brain MRI 
X 
 
 
 
 
 
 
 
 
 
 
Perform only if signs or symptoms suggestive of 
brain metastases at/during screening, or required by 
local SOC.  See Section 8.3.2. 
Survival status 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
*After documented disease progression, the start of 
new anticancer therapy, or discontinuation of study 
treatment/drug; contacts are approximately every 
12 weeks. 
Updated survival status may be requested by the 
sponsor at any time during the course of the study. 
Poststudy anticancer 
therapy 
 
 
 
 
 
 
 
 
X 
X 
X 
Subsequent anticancer therapy types, duration 
dates, response, disease progression assessed by 
investigator will be collected in the eCRF. 

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Table 3: 
Schedule of Activities for Participants With Nonsquamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C17 
C18 to 
C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d + 3 d of discona 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Local laboratory assessments 
Blood chemistries 
X* 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory results must be known before dosing. 
*Laboratory tests for screening are to be performed 
within 10 days before the first dose of study 
treatment. 
Hematology 
X* 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory results must be known before dosing. 
*Laboratory tests for screening are to be performed 
within 10 days before the first dose of study 
treatment. 
Endocrine function 
(T3 or FT3, FT4, and 
TSH) 
X 
 
X 
 
X 
 
X* 
X* 
X 
X 
 
Participants may be dosed in subsequent cycles after 
Cycle 1 Day 1 while thyroid function tests are 
pending. 
Tests will be performed by a central laboratory only 
if the local laboratory is unable to perform this 
service. 
*To be repeated every other cycle beginning with 
Cycle 6. 
Coagulation 
parameters 
X 
 
 
 
 
 
 
 
 
 
 
To be repeated as clinically indicated. 
Urinalysis 
X 
 
 
 
 
 
X* 
X* 
X 
X 
 
*To be repeated every 6 cycles beginning with 
Cycle 6. 
Pregnancy testing 
X* 
 
X** X** X** X** 
X** 
X** 
X** 
X* 
 
Results must be known before dosing. 
*Serum pregnancy test is performed at screening 
(within 72 hours of C1D1) and safety follow-up. 
**During treatment for every cycle and at EOT, 
urine pregnancy testing is acceptable. 
Serology 
(Hepatitis B & C)  
X 
 
 
 
 
 
 
 
 
 
 
May use central lab only if local lab is not capable.  
If serology is conducted within 60 days before 
randomization, testing does not need to be repeated.  
See Section 8.1.2 and Appendix D. 
HIV testing 
X 
 
 
 
 
 
 
 
 
 
 
Not required unless mandated by local health 
authority. 

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Table 3: 
Schedule of Activities for Participants With Nonsquamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C17 
C18 to 
C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d + 3 d of discona 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
EGFR, ALK, BRAF, 
ROS1 testing 
documentation 
X 
 
 
 
 
 
 
 
 
 
 
Needs to be previously documented only; if it is not 
previously documented, testing will need to be 
performed locally by the site or it can be sent for 
testing to the sponsor's central laboratory upon 
request. 
Pharmacokinetic/
assessments (central/sponsor) 
INCMGA00012  
 
X 
X 
 
X 
 
X 
X 
X 
X 
 
See Table 16 
 
Tumor tissue collection (central) 
Archival or newly 
obtained tissue 
collection for PD-L1 
analysis 
X 
 
 
 
 
 
 
 
 
 
 
 
Study treatment administration (no more than 3 days after randomized assignment) 
Cisplatin or 
carboplatin 
 
X 
X 
X 
X 
 
 
 
 
 
 
 
Pemetrexed 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Participants on pemetrexed who complete 35 cycles 
of INCMGA00012 or placebo may continue 
pemetrexed until reaching any other stopping 
criteria as per approved labeling.  Laboratory test of 
hematology and blood chemistry are minimally 
required at each cycle beyond 35 cycles. 
INCMGA00012 or 
placebo 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Participants assigned to the placebo arm may have 
the option of receiving INCMGA00012 open-label 
monotherapy in the crossover period if there is 
documented PD by central radiological review and 
study entry criteria are met (see Table 5). 
a If the EOT visit occurs > 21 days after the last study treatment, only a single EOT/30-day follow-up visit is required, and all unique assessments for the EOT and 30-day 
follow-up visit will be performed once. 

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Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell Lung Cancer 
Note:  Squamous NSCLC histology enrollment cap was met prior to Protocol Amendment 1; therefore, only applicable updates for 
ongoing participants will be made. 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
Cycles 1-4 
C5 C6 to C17 C18 to C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D8a 
D15a 
D1 
D1 
D1 
Evaluation Window 
± 1 d 
± 1 d ± 3 d 
± 3 d 
± 3 d 
+ 3 d of disconb 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Administrative procedures 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
Contact IRT 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
 
 
 
 
 
 
 
General and 
NSCLC-specific 
medical history  
X 
 
 
 
 
 
 
 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
*After the safety follow-up visit, record all 
medication taken for SAEs as defined in 
Section 9.4. 
Participant 
Identification Card 
X 
 
 
 
 
 
 
 
 
 
After the participant is found eligible. 
Clinical procedures/assessments 
AE assessment 
(CTCAE v5) 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
 
*Participants will be evaluated for 
AEs/SAEs from the consent through 
90 days after the last dose of study drug or 
until 30 days if new anticancer therapy was 
initiated.  See Section 8.7.1 and Section 9. 
Physical 
examination/body 
weight, height* 
X 
X 
 
 
X 
X 
X 
X 
X 
 
Comprehensive examination at screening 
and safety follow-up; targeted examination 
for all other assessments. 
*Height at screening or before dosing on 
Cycle 1, only. 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
12-lead ECG 
X 
 
 
 
 
 
 
 
X 
 
 
ECOG performance 
status 
X* 
X** 
 
 
X 
X 
X 
X 
X 
 
*ECOG for screening is to be performed 
within 10 days before the first dose of study 
drug. 
**Does not have to be done if screening 
ECOG was performed within 3 days before 
Cycle 1. 

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Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
Cycles 1-4 
C5 C6 to C17 C18 to C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D8a 
D15a 
D1 
D1 
D1 
Evaluation Window 
± 1 d 
± 1 d ± 3 d 
± 3 d 
± 3 d 
+ 3 d of disconb 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Efficacy assessments 
Tumor imaging 
X 
X* 
 
 
X* 
X* 
X** 
X*** 
 
 
*First on-study image will be performed at 
6 weeks (± 7 days) from the randomization 
date. Imaging performed to assess response 
every 6 weeks (42 ± 7 days) for 24 weeks, 
then every 9 weeks (63 ± 7 days) for the 
next 27 weeks, and subsequently every 
12 weeks (84 ± 14 days) until PD is verified 
by BICR.  Imaging assessments are to be 
performed using the same imaging schedule 
regardless of dose delays. 
**Imaging performed every 12 weeks 
(84 days ± 14 days) subsequently until PD. 
***If a previous scan was obtained within 
4 weeks before the date of discontinuation, 
then a scan at EOT is not mandatory. 
Brain MRI 
X 
 
 
 
 
 
 
 
 
 
Perform only if signs or symptoms 
suggestive of brain metastases at screening, 
or required by local SOC.  See 
Section 8.3.2. 
Survival status 
 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
*After documented disease progression, the 
start of new anticancer therapy, or 
discontinuation of study treatment/drug; 
contacts are approximately every 12 weeks. 
Updated survival status may be requested 
by the sponsor at any time during the course 
of the study. 

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Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
Cycles 1-4 
C5 C6 to C17 C18 to C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D8a 
D15a 
D1 
D1 
D1 
Evaluation Window 
± 1 d 
± 1 d ± 3 d 
± 3 d 
± 3 d 
+ 3 d of disconb 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Poststudy anticancer 
therapy 
 
 
 
 
 
 
 
X 
X 
X 
Subsequent anticancer therapy types, 
duration dates, response, disease 
progression assessed by investigator will be 
collected in the eCRF. 
Local laboratory assessments 
Blood chemistries 
X* 
X** 
X*** X*** 
X 
X 
X 
X 
X 
 
Laboratory results must be known before 
dosing. 
*Laboratory tests for screening are to be 
performed within 10 days before the first 
dose of study drug. 
**To be performed at Cycles 2, 3, and 4. 
***Applicable only to participants 
receiving nab-paclitaxel. 
Hematology 
X* 
X** 
X*** X*** 
X 
X 
X 
X 
X 
 
Laboratory results must be known before 
dosing. 
*Laboratory tests for screening are to be 
performed within 10 days before the first 
dose of study drug. 
**To be performed at Cycles 2, 3, and 4. 
***Applicable only to participants 
receiving nab-paclitaxel. 
Endocrine function 
(T3 or FT3, FT4, 
and TSH) 
X 
X* 
 
 
 
X** 
X** 
X 
X 
 
Participants may be dosed in subsequent 
cycles after Cycle 1 Day 1 while thyroid 
function tests are pending. 
Tests will be performed by a central 
laboratory only if the local laboratory is 
unable to perform this service. 
*To be performed at Cycle 2 and Cycle 4 
**To be repeated every other cycle 
beginning with Cycle 6. 
Coagulation 
parameters 
X 
 
 
 
 
 
 
 
 
 
To be repeated as clinically indicated. 
Urinalysis 
X 
 
 
 
 
X* 
X* 
X 
X 
 
*To be repeated every 6 cycles beginning 
with Cycle 6. 

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Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
Cycles 1-4 
C5 C6 to C17 C18 to C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D8a 
D15a 
D1 
D1 
D1 
Evaluation Window 
± 1 d 
± 1 d ± 3 d 
± 3 d 
± 3 d 
+ 3 d of disconb 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Pregnancy testing 
X* 
X** 
 
 
X** 
X** 
X** 
X** 
X* 
 
Results must be known before dosing. 
*Serum pregnancy test is performed at 
screening (within 72 hours of C1D1) and 
safety follow-up. 
**During treatment, starting with C2D1, at 
every cycle and at EOT, urine pregnancy 
testing is acceptable. 
Serology 
(Hepatitis B & C)  
X 
 
 
 
 
 
 
 
 
 
May use central lab only if local lab is not 
capable.  If serology is conducted within 
60 days before randomization, testing does 
not need to be repeated.  See Section 8.1.2 
and Appendix D. 
HIV testing 
X 
 
 
 
 
 
 
 
 
 
Not required unless mandated by local 
health authority. 
EGFR, ALK, ROS1, 
BRAF testing 
documentation 
X 
 
 
 
 
 
 
 
 
 
Not required for pure squamous histology.  
In cases where the tumor is mixed or not 
completely known, testing must be 
performed locally (or it can be sent for 
testing to the sponsor's central laboratory 
upon request), or previous documentation 
showing the absence of these mutations 
must be available. 
Pharmacokinetic
 assessments (central/sponsor) 
INCMGA00012  
 
X* 
 
 
 
X 
X 
X 
X 
 
See Table 16. 
*Not at Cycle 3. 
  

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Table 4: 
Schedule of Activities for Participants With Squamous Non–Small Cell Lung Cancer (Continued) 
Visit 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuation 
Post-Treatment 
Notes 
Cycles 1-4 
C5 C6 to C17 C18 to C35 
Safety 
Follow-Up 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D8a 
D15a 
D1 
D1 
D1 
Evaluation Window 
± 1 d 
± 1 d ± 3 d 
± 3 d 
± 3 d 
+ 3 d of disconb 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Tumor tissue collection (central) 
Archival or newly 
obtained tissue 
collection for PD-L1 
analysis 
X 
 
 
 
 
 
 
 
 
 
 
Study treatment administration (no more than 3 days after randomized assignment) 
Carboplatin 
 
X 
 
 
 
 
 
 
 
 
Carboplatin is administered on Day 1 for 
Cycles 1, 2, 3, and 4.  See Section 6.1.3. 
Paclitaxel 
 
X 
 
 
 
 
 
 
 
 
Paclitaxel is administered on Day 1 for 
Cycles 1, 2, 3, and 4.  Paclitaxel should be 
completely administered before initiating 
carboplatin dose.  See Section 6.1.3. 
Nab-paclitaxel 
 
X 
X 
X 
 
 
 
 
 
 
Nab-paclitaxel is administered on Days 1, 8, 
and 15 for Cycles 1, 2, 3, and 4.  
Nab-paclitaxel should be completely 
administered before initiating carboplatin 
dose.  See Section 6.1.3. 
INCMGA00012 or 
placebo 
 
X 
 
 
X 
X 
X 
 
 
 
Participants assigned to the placebo arm 
may have the option of receiving 
INCMGA00012 open-label monotherapy in 
the crossover period if there is documented 
PD by central radiological review and study 
entry criteria are met (see Table 5).  
a Cycle 1-4 Days 8 and 15 procedures apply only to participants receiving nab-paclitaxel. 
b If the EOT visit occurs > 21 days after the last study treatment, only a single EOT/30-day follow-up visit is required, and all unique assessments for the EOT and 30-day follow 
up visit will be performed once. 

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Table 5: 
Crossover Period Schedule of Activities 
Visit 
Entry Study 
Criteria/ 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuationa 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C13 
C14 to 
C35 
Safety 
Follow-Upb 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d 
+ 3 d of discon 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Administrative procedures 
Contact IRT 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
Prior/concomitant 
medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
*After the safety follow-up visit record 
all medication taken for SAEs as defined 
in Section 9.2. 
Poststudy anticancer 
therapy 
 
 
 
 
 
 
 
 
X 
X 
X 
 
Survival status 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
After documented disease progression, 
the start of new anticancer treatment, or 
discontinuation of study drug; contacts 
are approximately every 12 weeks. 
Clinical procedures/assessments 
AE assessment 
(CTCAE v5) 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X* 
 
*Once a participant discontinues study 
drug (INCMGA00012), report all 
AEs/SAEs, occurring within 90 days 
following cessation of study drug, or 
30 days following cessation of treatment 
if new anticancer therapy is initiated.  
See Section 8.7.1 and Section 9. 
Physical 
examination/body 
weight 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Comprehensive examination at safety 
follow-up; targeted examination for all 
other assessments. 
Vital signs 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
ECOG performance 
status 
X* 
X** 
X 
X 
X 
X 
X 
X 
X 
X 
 
*ECOG for screening is to be performed 
within 10 days before the first dose of 
study drug. 
**Does not have to be done if screening 
ECOG was performed within 3 days 
before Cycle 1. 

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit 
Entry Study 
Criteria/ 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuationa 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C13 
C14 to 
C35 
Safety 
Follow-Upb 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d 
+ 3 d of discon 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Efficacy assessments 
Tumor imaging 
X* 
 
 
 
 
X** 
X** 
X** 
X 
 
X*** 
BICR verifying progressive disease is 
1) required for crossover (no exceptions), 
and 2) based on RECIST v1.1. 
*There must not be more than 12 weeks 
(84 days + 14 days) between last scan on 
study treatment that confirmed PD by 
central imaging vendor and first scan in 
crossover period. 
**Once in crossover period, tumor 
response by the investigator's assessment 
is required every 12 weeks (84 days ± 
14 days) regardless of any treatment 
delays, until the participant starts another 
subsequent anticancer treatment. 
Once participant stops imaging 
assessments (eg, PD or starting a new 
anticancer therapy) the participant moves 
into the survival follow-up period. 
 
 
 
 

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit 
Entry Study 
Criteria/ 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuationa 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C13 
C14 to 
C35 
Safety 
Follow-Upb 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d 
+ 3 d of discon 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Local laboratory assessments 
Blood chemistries 
X* 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory results must be known before 
dosing. 
*Laboratory tests for screening are to be 
performed within 10 days before the first 
dose of study drug. 
Hematology 
X* 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
Laboratory results must be known before 
dosing. 
*Laboratory tests for screening are to be 
performed within 10 days before the first 
dose of study drug. 
Endocrine function 
(T3 or FT3, FT4, 
and TSH) 
X 
X 
X 
 
X 
 
X* 
X* 
X 
X 
 
Participants may be dosed at subsequent 
cycles after Cycle 1, Day 1 while thyroid 
function tests are pending. 
Tests will be performed by a central 
laboratory only if the local laboratory is 
unable to perform this service. 
*To be repeated every other cycle 
beginning with Cycle 6.  
Coagulation 
parameters 
X 
 
 
 
 
 
 
 
 
 
 
To be repeated as clinically indicated. 
Urinalysis 
X 
 
 
 
 
X 
X* 
X* 
X 
X 
  
*To be performed at Cycles 9 and 13 and 
to be repeated every 6 cycles beginning 
with Cycle 13.   
Pregnancy testing 
X 
 
X 
X 
X 
X 
X 
X 
X 
X* 
 
Results must be known before dosing. 
Urine or serum test. 
*Serum pregnancy test is performed at 
safety follow-up. 

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Table 5: 
Crossover Period Schedule of Activities (Continued) 
Visit 
Entry Study 
Criteria/ 
Screening 
Treatment Cycles (3-Week Cycles) 
EOT/ 
at Time of 
Discontinuationa 
Post-Treatment 
Notes 
C1 
C2 
C3 
C4 
C5 
C6 to 
C13 
C14 to 
C35 
Safety 
Follow-Upb 
Survival 
Follow-Up 
Days 
-28 to -1 
D1 
D1 
D1 
D1 
D1 
D1 
D1 
Evaluation Window 
± 3 d ± 3 d ± 3 d ± 3 d ± 3 d 
± 3 d 
+ 3 d of discon 
EOT + 30 d 
(± 7 d) 
Q12W 
(± 14 d) 
Study drug administration 
Administer 
INCMGA00012 
monotherapy 
 
X* 
X 
X 
X 
X 
X 
X 
 
 
 
Up to 35 cycles (~2 years) 
If treatment is adjusted, all procedures 
except imaging will be completed 
according to the cycle number and not 
weeks on treatment. 
*Treatment should not initiate until at 
least 21 days after last dose of 
chemotherapy regardless of the time of 
progression. 
Note:  Only for eligible participants as described in the Crossover Period Study Drug Treatment and Criteria (see Section 6.7).  Eligible participants who had verified PD 
(RECIST v1.1) by blinded independent central radiologic review first and who after unblinding were on placebo plus chemotherapy arm after randomization.  Eligible crossover 
participants may receive open-label monotherapy INCMGA00012 of up to 35 cycles, or up to 2 years. 
a All procedures and assessments completed at the time of withdrawal from the main study (blinded) may be used as appropriate for the start of the crossover period of the study.  
If participants continue into the crossover period, the safety follow-up visit is not required from the main study. 
b If the EOT visit occurs within 30 days from last dose of INCMGA00012, at the time of the required safety follow-up visit, procedures do not need to be repeated. 

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2. 
INTRODUCTION 
2.1. 
Background 
2.1.1. 
Metastatic Non–Small Cell Lung Cancer 
The World Health Organization estimates that lung cancer is the cause of 1.59 million deaths 
globally per year (Planchard et al 2019).  The worldwide numbers are still rising despite an 
ongoing small decline in the Western world (Postmus et al 2017).  Non–small cell lung cancer 
accounts for 80% to 90% of lung cancers, while SCLC has been decreasing in frequency in many 
countries over the past 2 decades (Jemal et al 2011). 
Approximately 70% of patients with NSCLC have advanced disease not amenable to surgical 
resection at the time of diagnosis.  The 5-year relative survival for patients with any lung cancer 
overall and metastatic lung cancer specifically has been reported to be 17.7% and 4.3%, 
respectively (NCI 2019). 
Immunotherapy has had a major impact on outcomes for patients with metastatic NSCLC with 
multiple PD-1 and PD-L1 inhibitors now approved in several countries for the treatment of 
locally advanced or metastatic disease.  For chemotherapy-naive patients, pembrolizumab 
(Keytruda®) for example was originally approved as monotherapy in the setting of high PD-L1 
expressing tumors (tumor proportion score of ≥ 50%) based on favorable survival outcome 
compared with platinum-based chemotherapy (Reck et al 2016).  In this study, which compared 
pembrolizumab monotherapy with the investigator's choice of platinum-based chemotherapy, 
PFS, OS at 6 months, ORR, and incidence of treatment-related AEs of any grade favored the 
pembrolizumab treatment group. 
The benefits of the combination of immunotherapy and conventional chemotherapy have been 
demonstrated extensively in some but not all randomized and controlled clinical studies.  In the 
setting of chemotherapy-naive NSCLC regardless of PD-L1 expression, 6 randomized, 
controlled clinical studies showed significant prolongation of PFS and increased tumor response 
when adding a PD-(L)1 inhibitor to a platinum-based chemotherapy doublet (Borghaei 
et al 2018, Borghaei et al 2019, Gandhi et al 2018, Jotte et al 2018, Paz-Ares et al 2018, Socinski 
et al 2018).  Pembrolizumab and atezolizumab are both approved in the first-line NSCLC 
population in combination with platinum-based chemotherapy based on Phase 3 data described 
below. 
In Study KEYNOTE-189 (NCT02578680) in patients with previously untreated metastatic 
nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to 
standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer 
OS and PFS than chemotherapy alone, regardless of PD-L1 expression level (Gandhi et al 2018).  
In this study, the estimated rate of OS at 12 months was 69.2% (95% CI:  64.1, 73.8) in the 
pembrolizumab-combination group versus 49.4% (95% CI: 42.1, 56.2) in the 
placebo-combination group (hazard ratio for death, 0.49; 95% CI:  0.38, 0.64; p < 0.001) after a 
median follow-up of 10.5 months.  Median PFS was 8.8 months (95% CI:  7.6, 9.2) in the 
pembrolizumab combination group and 4.9 months (95% CI:  4.7, 5.5) in the placebo 
combination group (hazard ratio for disease progression or death, 0.52; 95% CI:  0.43, 0.64; 
p < 0.001).  Likewise, in Study KEYNOTE-407 (NCT02775435) in patients with previously 

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untreated metastatic squamous NSCLC, the addition of pembrolizumab to chemotherapy 
(carboplatin and paclitaxel or nab-paclitaxel) with carboplatin plus paclitaxel or nab-paclitaxel 
resulted in significantly longer OS and PFS than chemotherapy alone (Paz-Ares et al 2018).  The 
median OS was 15.9 months (95% CI:  13.2, not reached) in the pembrolizumab-combination 
group and 11.3 months (95% CI:  9.5, 14.8) in the placebo-combination group (hazard ratio for 
death, 0.64; 95% CI:  0.49, 0.85; p < 0.001) after a median follow-up of 7.8 months.  The OS 
benefit was consistent regardless of the level of PD-L1 expression.  The median PFS was 
6.4 months (95% CI:  6.2, 8.3) in the pembrolizumab combination group and 4.8 months 
(95% CI:  4.3, 5.7) in the placebo combination group (hazard ratio for disease progression or 
death, 0.56; 95% CI:  0.45, 0.70; p < 0.001). 
In IMpower150 (NCT02366143), metastatic nonsquamous NSCLC patients were randomly 
assigned to receive atezolizumab plus carboplatin plus paclitaxel, BCP, or ABCP every 3 weeks 
for 4 or 6 cycles, followed by maintenance therapy with atezolizumab, bevacizumab, or both.  
The addition of atezolizumab to bevacizumab plus chemotherapy significantly improved 
PFS and OS among patients with metastatic nonsquamous NSCLC, regardless of PD-L1 
expression and EGFR or ALK genetic alteration status.  The median PFS was longer in the 
ABCP group than in the BCP group (8.3 months vs 6.8 months; hazard ratio for disease 
progression or death, 0.62; 95% CI:  0.52, 0.74; p < 0.001).  Progression-free survival was also 
longer in the ABCP group than in the BCP group in the entire intent-to-treat population and 
among patients with low or negative PD-L1 expression.  Median OS among the patients in the 
wild-type genotype population was longer in the ABCP group than in the BCP group 
(19.2 months vs 14.7 months; hazard ratio for death, 0.78; 95% CI:  0.64, 0.96; p = 0.02; 
Socinski et al 2018). 
Access to these important therapies is not universal, and clinical trials are an important 
mechanism for providing access to promising therapies where it may otherwise be limited 
(eg, due to labeling restrictions or insufficient reimbursement).  In addition, questions still 
remain regarding optimization of therapy for patients with lower levels of PD-L1 expression and 
in those whose tumors exhibit targetable driver mutations such as EGFR, ALK, ROS1, or BRAF 
(ASCO 2017, da Veiga et al 2018, NCCN 2019).  Based on the experience with pembrolizumab 
and atezolizumab, it is reasonable to anticipate that other PD-(L)1 inhibitors may provide clinical 
benefit in similar populations.  In this study, we plan to determine whether the addition of the 
PD-1 inhibitor, INCMGA00012, to platinum-based chemotherapy will improve survival in the 
initial treatment of nonsquamous and squamous metastatic NSCLC. 
2.1.2. 
INCMGA00012 
INCMGA00012 is a humanized, hinge-stabilized, IgG4-κ monoclonal antibody that recognizes 
human PD-1.  INCMGA00012 contains a human IgG4 Fc domain to limit effector function 
while retaining neonatal Fc receptor binding to extend circulating half-life.  INCMGA00012 is 
designed to target PD-1–expressing cells, including T cells, and sustain/restore their effector 
function by blocking checkpoint inhibitory interactions between PD-1 and its 2 ligands, PD-L1 
and PD-L2. 
In vitro studies with INCMGA00012 have demonstrated high affinity binding to both 
recombinant human and cynomolgus monkey PD-1 as well as to PD-1 that is naturally expressed 
on the cell surface, including on T cells.  Consistent with its intended mechanism of action and 

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functional properties, INCMGA00012 has been shown to inhibit the binding of PD-L1 and 
PD-L2 to PD-1, to disrupt the PD-1/PD-L1 inhibitory axis, and to enhance interferon-γ secretion 
in staphylococcus enterotoxin B–stimulated human peripheral blood mononuclear cells with 
activity comparable to pembrolizumab and nivolumab replicas (generated by MacroGenics, Inc. 
based on the published sequences of these antibodies).  INCMGA00012 does not induce 
antibody-dependent cellular cytotoxicity or complement-dependent cytotoxicity, mitogenic 
activity, hemolysis, or cytokine release. 
As of 23 SEP 2019, 230 participants have been enrolled in the first-in-human monotherapy study 
(INCMGA 0012-101, NCT03059823).  Interim results of both the dose-escalation and the 
expansion portion of Study INCMGA 0012-101 have been reported along with updated clinical 
and translational pharmacology (Chen et al 2019, Condamine et al 2019, Lakhani et al 2017, 
Mehnert et al 2018, Mehnert et al 2019).  Four expansion cohorts (ie, endometrial cancer, 
cervical cancer, soft tissue sarcoma, and NSCLC) treated with 3 mg/kg Q2W and 3 fixed dose 
cohorts (ie, 500 mg Q4W, 750 mg Q4W, and 375 mg Q3W; Mehnert et al 2018) were enrolled.  
Results of the dose-escalation portion of Study INCMGA 0012-101 demonstrated acceptable 
tolerability with no DLTs observed at any dose level up to 10 mg/kg Q2W.  An MTD was not 
reached.  For both the 3 and 10 mg/kg dose levels, Cmax and AUC0-∞ were dose-proportional.  
The t½ (β) was approximately 17 days, and steady state was achieved in approximately 85 days.  
Full and sustained receptor occupancy of INCMGA00012 on both CD4+ and CD8+ T cells 
along with complete loss of competing fluorescently labeled anti–PD-1 staining were seen at all 
dose levels (Condamine et al 2019, Lakhani et al 2017). 
Among the 230 participants receiving INCMGA00012 in Study INCMGA 0012-101, 
171 participants received weight-based doses of 1 mg/kg, Q2W, 3 mg/kg Q2W or Q4W, or 
10 mg/kg Q2W or Q4W, and 59 participants received flat dosing at 375 mg Q3W, 500 mg Q4W, 
or 750 mg Q4W with acceptable tolerability.  Overall, 92% of participants had at least 1 TEAE, 
including 57% of participants with treatment-related TEAEs, and 46.1% of participants with 
≥ Grade 3 TEAEs.  Serious TEAEs, most of which were not considered related to study 
treatment, were reported for 27% of participants.  Twenty-nine participants had irAEs, most of 
which were not serious.  Most irAEs were transient, with the exception of endocrine-related 
irAEs.  Nonendocrine irAEs that had not resolved as of the data cutoff date of 23 SEP 2019 were 
lipase increased, diarrhea, ALT increased, blood bilirubin increased, fatigue, colitis, and 
hyperglycemia (all 1 participant each). 
Confirmed RECIST v1.1 responses were observed in all the expansion cohorts, none of which 
had been enriched by a predictive biomarker (eg, microsatellite instability [MSI] or PD-L1 
status).  Specifically, 5/35 (14.3%) of the evaluable NSCLC participants 4/29 (13.8%) 
endometrial cancer participants, 1/35 sarcoma participant, and 6/35 (17.1%) cervical cancer 
participants had confirmed RECIST responses (data on file; Mehnert et al 2019).  Participants in 
the NSCLC cohort (3 mg/kg Q2W) were required to have previously received platinum-based 
chemotherapy.  Of the 5 evaluable NSCLC participants who had confirmed RECIST v1.1 
responses, 1 had PD-L1 TPS < 1%, 3 had PD-L1 TPS ≥ 50%, and 1 was unknown.  In the cohort 
of NSCLC participants, the clinical activity of INCMGA00012 is similar to published experience 
for pembrolizumab and atezolizumab in platinum-refractory NSCLC (Herbst et al 2016, Peters 
et al 2017). 

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Based on clinical experience, the safety profile of INCMGA00012 appears to be representative 
of the PD-(L)1 inhibitor class. 
2.2. 
Study Rationale 
2.2.1. 
Rationale for Study Design 
Non–small cell lung cancer remains the most common non–skin cancer worldwide and, despite 
recent advances in treatment for advanced disease, the survival outcomes are measured only in 
months.  Incremental progress has been made with platinum-based chemotherapy, and more 
recently with the addition of the PD-(L)1 inhibitors pembrolizumab or atezolizumab to standard 
of care chemotherapy (Gandhi et al 2018, Paz-Arez et al 2018, Socinski et al 2018).  Despite 
these notable advances, access to life-saving therapies is frequently limited by regulatory 
approval or reimbursement considerations (ASCO 2017, da Veiga et al 2018).  This study 
incorporates a crossover design so that all participants who meet study criteria will have the 
opportunity to receive INCMGA00012. 
2.2.2. 
Scientific Rationale for Study Design 
Similar inclusion and exclusion criteria that were used in the pivotal Phase 3 studies of 
KEYNOTE-189 and KENOTE-407 as first-line therapy for participants with metastatic NSCLC 
(Gandhi et al 2018, Paz-Arez et al 2018) will be used to determine eligibility in this study in 
order to define a population with high likelihood of benefit to anti–PD(L)-1 monoclonal 
antibodies. 
Participants who are eligible for effective targeted therapy against a known driver mutation such 
as EGFR, ALK, ROS1, or BRAF will not be included in the study population since the 
effectiveness of PD-(L)1 chemotherapy combinations has not been definitively established in 
these tumor types (Lisberg et al 2018, NCCN 2019).  As the current research study will enroll 
both nonsquamous and squamous NSCLC histologies (versus a single study for each histologic 
subtype of NSCLC), enrollment of participants will approximate the expected frequency of these 
histologies in the general population.  This expected frequency is in order to account for any 
potential differences in prognosis and/or the effect of INCMGA00012 treatment.  For OS 
analysis, the target of OS events will provide 87% power for detection of the planned HR.  Refer 
to Section 10 for details. 
2.2.3. 
Justification for INCMGA00012 Dose 
INCMGA00012 has been administered in the clinic as both a weight-based dose (ranging from 
1 to 10 mg/kg Q2W) and at fixed doses of 375 mg Q3W, 500 mg Q4W, and 750 mg Q4W.  
Treatment has been well tolerated over the entire dosing range, and an MTD has not been 
reached (Lakhani et al 2017, Mehnert et al 2018). 
Fixed doses have several advantages over weight-based doses, including convenience of 
preparation and administration, reduction of errors in preparation calculations, and minimization 
of drug waste.  Body size–based doses and fixed doses of monoclonal antibodies have been 
evaluated, and the 2 approaches performed similarly, with body size–based doses not always 
offering an advantage in reducing variability of exposure (Bai et al 2012, Wang et al 2009). 

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A flat dose of 500 mg was explored in an expansion cohort of Study INCMGA 0012-101.  Based 
on this experience, the 500 mg Q4W dose had very similar PK properties to 3 mg/kg Q2W 
dosing and had approximately a 58% probability for steady-state trough serum concentration 
≥ 21 μg/mL (Chen et al 2019), which is associated with maximum target engagement and 
greatest probability of efficacy, based on pembrolizumab data (Freshwater et al 2017). 
Safety data from 15 participants receiving INCMGA00012 375 mg Q3W show that 
93% reported any TEAE.  Overall, 60% of participants had a TEAE that was considered at least 
possibly related to study treatment, and 47% of participants had TEAEs ≥ Grade 3.  Serious 
TEAEs were reported for 40% of participants, with none considered related to study treatment.  
No events resulted in study drug withdrawal and no events had a fatal outcome.  Immune-related 
adverse events were reported in this dose group.  The TEAEs (any grade) reported in > 10% of 
participants included alkaline phosphatase increased (n = 3; 20%), tumor pain (n = 3; 20%), and 
anemia, gastritis, fatigue, influenza-like illness, AST increased, amylase increased, bilirubin 
increased, lymphocytes decreased, hypomagnesaemia, pain in extremity, tumor flare, cough, 
dyspnea, and pruritus (n = 2 each; 13% each). 
The 375 mg Q3W flat dose regimen was selected in order to maintain steady-state trough serum 
concentration ≥ 21 μg/mL as well as to provide additional flexibility in combinations (eg, with 
chemotherapy).  Pharmacokinetic data were obtained from 14 participants with samples who 
received INCMGA00012 375 mg Q3W in the cohort expansion portion of Study 
INCMGA 0012-101.  Following a first dose of 375 mg Q3W, INCMGA00012 had t½ (11.5 days) 
and CL (14.8 mL/minute) values comparable to those of the 500 mg Q4W and 750 mg Q4W 
doses.  Furthermore, simulated Cmin,ss PK following a 375 mg Q3W infusion was 24,300 ng/mL 
with the accumulation ratio at approximately 1.4, making this a comparable dose to 500 mg 
Q4W. 
Based on these observations, both 500 mg Q4W and 375 mg Q3W were selected as flat dose 
regimens for further development for the INCMGA00012 program. 
2.2.4. 
Rationale for the Use of Placebo 
The use of placebo in combination with standard chemotherapy will ensure the objectivity of 
investigator-assessed progression as well as any decisions to interrupt/discontinue therapy.  Since 
randomization and placebo use can be a perceived barrier to participant enrollment, a 
2:1 randomization in favor of the active arm will be used to increase the likelihood that 
participants will be assigned to the active arm and therefore enhance participant accrual.  
Participants assigned to INCMGA00012 placebo will also have the opportunity to receive 
INCMGA00012 monotherapy upon verified progression if protocol-defined conditions are met. 
2.2.5. 
Benefit/Risk Assessment 
Antibodies targeting the PD-1 pathway have proven efficacy against a wide variety of cancer 
types (Song et al 2020), and the available preclinical and clinical data from trial participants 
suggest that the pharmacologic and clinical profile of INCMGA00012 should be consistent with 
experience with other drugs in this class.  Based on these observations, the benefit/risk for 
INCMGA00012 should also be favorable, provided efficacy objectives in the proposed study are 
met.  The investigational nature of INCMGA00012 is clearly described in the ICF, which also 
notes that participants would be asked to forego treatment alternatives including some for which 

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a survival benefit has been established.  However, access to approved important new therapies is 
not universal due to reimbursement obstacles, and questions remain regarding optimization of 
therapy for patients with lower levels of PD-L1 expression (ASCO 2017, da Veiga et al 2018, 
NCCN 2019). 
Treatment with INCMGA00012 in early clinical studies has been generally well tolerated.  
Results from the dose-escalation portion of the first-in-human monotherapy study of 
INCMGA00012 in participants with advanced cancer (Study INCMGA 0012-101) have been 
presented (Lakhani et al 2017, Mehnert et al 2018).  INCMGA00012 demonstrated acceptable 
tolerability at all dose levels tested with preliminary signals of efficacy in several expansion 
cohorts.  The safety profiles of anti–PD-1 therapies and platinum-based chemotherapy are not 
expected to overlap; therefore, the tolerability of this combination is not expected to be 
significantly worse than either agent alone. 
The combination of PD-(L)1 monoclonal antibodies and taxanes (such as paclitaxel and 
nab-paclitaxel) have been investigated in clinical studies that show a toxicity profile consistent 
with the known safety profile of each of these drugs (Paz-Ares et al 2018, Schmid et al 2018).  In 
the KEYNOTE-407 study, pembrolizumab was combined with carboplatin and paclitaxel or 
nab-paclitaxel in participants with squamous NSCLC and compared with placebo in combination 
with carboplatin and paclitaxel or nab-paclitaxel.  A total of 69.8% of the pembrolizumab group 
and 68.2% of the placebo group had AEs ≥ Grade 3.  The discontinuation of study treatment due 
to AEs was more frequent in the pembrolizumab group than in the placebo group (13.3% vs 
6.4%, respectively; Paz-Ares et al 2018).  In the KEYNOTE-189 study, AEs ≥ Grade 3 occurred 
in 67.2% of the participants in the pembrolizumab-combination group and in 65.8% of those in 
the placebo-combination group.  Discontinuation of all study drugs because of AEs occurred in 
13.8% of the participants in the pembrolizumab combination group and in 7.9% of those in the 
placebo-combination group; discontinuation rates of pembrolizumab and placebo were 20.2% 
and 10.4%, respectively.  The rates of AEs were similar in participants who received carboplatin 
and cisplatin (Gandhi et al 2018). 
Atezolizumab was combined with nab-paclitaxel in participants with triple-negative breast 
cancer in the IMpassion 130 study.  Similar to KEYNOTE-407, in this study, the discontinuation 
of study treatment due to AEs was higher in the atezolizumab group, with 15.9% of participants 
discontinuing study treatment due to an AE in the atezolizumab group compared with 8.2% in 
the placebo group (Schmid et al 2018). 
Oversight of study conduct will be provided by an eDMC.  Additionally, irAEs will be 
monitored throughout the study with appropriate guidance provided to investigators for their 
assessment and management.  The eDMC will perform a safety review after approximately 
45 participants have been randomized and completed at least 1 cycle of study treatment.  The 
eDMC will continue to review safety data throughout the duration of the study, including review 
of irAEs as described in the eDMC Charter. 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of INCMGA00012 may be found in the IB.  More detailed information about the 
known and expected benefits and risks of the chemotherapy regimens to be used may be found in 
the approved labels. 

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2.2.5.1. 
Benefit/Risk Assessment During the COVID-19 Pandemic 
In 2020, the ESMO and others highlighted the importance of clinical cancer research with 
immunotherapy or treatment with immunotherapy for patients with advanced cancer even during 
the unexpected COVID-19 pandemic, including potential investigational therapies similar to 
immunotherapy with a known survival benefit (Curigliano et al 2020).  Real-world data have 
indicated that the use of immunotherapy either alone or in combination with chemotherapy does 
not increase the risk of hospitalization upon SARS-CoV-2 infection (Horn et al 2020, 
Malek et al 2021, Ribas et al 2021) or cause an increased risk of mortality (Cohn et al 2021, 
Lee et al 2020, Ribas et al 2021, Sharafeldin et al 2021, Tenforde et al 2021).  While many 
efforts continue to be made to avoid becoming infected with SARS-CoV-2 (eg, proper social 
distancing, avoid unnecessary traveling), it is not always completely possible or enough; 
however, immunotherapy does not more negatively affect patients with cancer who are 
SARS-CoV-2–positive than those who test negative for SARS-CoV-2.  Cancer therapy with 
immune checkpoint inhibitors does not confer additional mortality risks in the setting of active 
COVID-19 (Goldman et al 2022). 
In a recent observational prospective study, Mandala et al (2021) screened 293 patients with 
cancer for SARS-CoV-2 and further identified patients who were treated with immunotherapy 
and compared them with patients with the same cancer subtypes treated with targeted therapy or 
chemotherapy.  Cancer subtypes included melanoma, NSCLC, renal cell carcinoma, and other.  
Mortality of SARS-CoV-2–positive patients was statistically significantly higher compared with 
SARS-CoV-2–negative patients (8/89 versus 3/204, respectively; p = 0.004).  All deaths were 
due to COVID-19. The incidence of SAEs in SARS-CoV-2–positive compared with 
SARS-CoV-2–negative patients was similar in patients treated with immunotherapy and 
chemotherapy (17.3% and 3.7% respectively for positive and negative patients treated with 
immunotherapy and 15.4% and 2.7% respectively for those treated with chemotherapy; 
Breslow-Day test p = 0.891).  Serious AEs were COVID-19–related rather than 
treatment-related, confirming previous studies that treatment with immune checkpoint 
inhibitors does not significantly increase the risk of SAEs compared with chemotherapy 
(Mandala et al 2021). 
Patients with lung cancer have a high risk of complications and death due to COVID-19 and 
would derive substantial benefit from efforts such as vaccination against SARS-CoV-2 (Passaro 
et al 2020).  As an at-risk population, there is a need for vaccinating these patients to avoid 
excess morbidity and mortality during the SARS-CoV2 pandemic (NCCN 2021b). Vaccinated 
patients with cancer living in areas of high SARS-CoV-2 infectivity may still contract 
COVID-19 but generally develop less severe disease and are less frequently hospitalized (Cohn 
et al 2021, Tenforde et al 2021).  The prevention of severe COVID-19 is particularly important 
considering that patients with cancer are already immunocompromised, which puts them at risk 
for infections and opportunistic complications due to treatment.  A diagnosis of SARS-CoV-2 
infection may also delay critical cancer treatment or cause the patient not to receive the full 
course of therapy. 
The availability of approved vaccines has provided an increased chance for patients with 
advanced cancer to be protected from or have less severe cases of COVID-19 (Ribas et al 2021, 
Cohn et al 2021, Tenforde et al 2021, Malek et al 2021, Sharafeldin et al 2021).  Aligned with 
the published data and recommendations from many international oncology societies, such as 

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ASCO, SITC, ESMO, NCCN, and AACR, the sponsor highly recommends that potential 
participants with NSCLC are vaccinated before entering the study or become fully vaccinated 
during the study, and/or receive booster doses according to country or local guidelines as 
available.  The efficacy of COVID-19 vaccination is high in patients undergoing therapy with 
immune checkpoint inhibitors (Goldman et al 2022).  This recommendation, in parallel with 
globally and publicly known principles to increase vaccination rates, is to minimize deaths 
related to COVID-19 and prevent severe cases of COVID-19 (ASCO 2021, ESMO 2021, 
Goldman et al 2022, Malek et al 2021, NCCN 2021b, Ribas et al 2021, SITC 2021). 
Further, the sponsor has implemented guidance for participation in the study in the context of the 
COVID-19 pandemic and study-treatment management in the event of SARS-CoV-2 infection (see 
Appendix G).  During the COVID-19 pandemic, unknown additional risks to participants may 
exist either related to going to a health care facility or as a result of study-related activities.  The 
investigators need to frequently assess the participant's available medical data (eg, performance 
status, past medical history, comorbidities) at screening coupled with the need to conduct the 
required primary endpoint study procedures in order to determine whether it is in the best 
interests of the potential participant to enroll and participate in the study during peaks and 
troughs of the COVID-19 pandemic.  Consented participants who are suspected of being exposed 
to SARS-CoV-2 or have symptoms will undergo COVID-19 testing to demonstrate recovery 
prior to randomization. 
Due to the dynamic changes of the COVID-19 pandemic, evolving country or local requirements 
may be followed with regard to COVID-19 testing frequency, diagnosis, and treatment.  
Participants will be monitored with safety procedures as described in Section 8 and with 
additional safety assessments as per standard of care.  Information regarding the flexibility of 
assessment/visit scheduling, where possible and warranted, and the strategy for participant 
management during the dynamic pandemic is described in Appendix G. 

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3. 
OBJECTIVES AND ENDPOINTS 
Table 6 represents the objectives and endpoints. 
Table 6: 
Objectives and Endpoints 
Objectives 
Endpoints 
Primary 
To compare the OS of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
OS, defined as the time from randomization until 
death due to any cause. 
Secondary 
To compare the PFS of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
PFS, defined as the time from randomization until 
disease progression by RECIST v1.1 as 
determined by BICR or death due to any cause. 
To compare the ORR of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
ORR, defined as the proportion of participants 
who have a confirmed CR or PR per 
RECIST v1.1 based on BICR. 
To compare the DOR of the combinations of 
INCMGA00012 and chemotherapy versus 
placebo and chemotherapy. 
DOR, defined as the time from the earliest date of 
documented response until earliest date of disease 
progression or death from any cause, whichever 
comes first, per RECIST v1.1 based on BICR. 
To evaluate the safety and tolerability of the 
combination of INCMGA00012 and 
chemotherapy and the combination of placebo and 
chemotherapy. 
Number of participants experiencing AEs and 
number of participants discontinuing study drug 
due to AEs. 
To evaluate the PK of INCMGA00012 375 mg 
Q3W when administered with chemotherapy. 
Population PK parameters (including Cmax, AUC) 
will be summarized. 

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4. 
STUDY DESIGN 
4.1. 
Overall Design 
This is a global, randomized, double-blind, study of IV INCMGA00012 or placebo combined 
with platinum-based chemotherapy in participants with metastatic squamous or nonsquamous 
NSCLC who have not previously received systemic therapy for advanced disease and who do not 
have sensitizing driver mutations or gene rearrangements such as EGFR, ALK, BRAF, or ROS1.  
Participants who received adjuvant/neoadjuvant therapy are permitted onto the study as long as 
therapy was completed at least 12 months before the diagnosis of metastatic disease. 
The primary endpoint of the study is OS.  Approximately 600 participants with NSCLC will be 
randomized 2:1 to either receive INCMGA00012 375 mg IV Q3W or placebo along with the 
standard of care platinum-based chemotherapy regimens as per below.  The investigator will 
select 1 of the chemotherapy combination agents (eg, pemetrexed plus cisplatin or pemetrexed 
plus carboplatin for nonsquamous NSCLC) and document in IVRS prior to randomization. 
• Participants with nonsquamous NSCLC will be randomized to receive 1 of the 
following: 
− INCMGA00012 375 mg IV (D1) Q3W with pemetrexed 500 mg/m2 + cisplatin 
75 mg/m2 (D1) Q3W OR carboplatin AUC 5 (D1) Q3W for 4 cycles followed by 
INCMGA00012 375 mg IV plus pemetrexed 500 mg/m2 Q3W until progression 
− Placebo IV (D1) Q3W with pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 (D1) 
Q3W OR carboplatin AUC 5 (D1) Q3W for 4 cycles followed by placebo IV plus 
pemetrexed 500 mg/m2 Q3W until progression 
• Participants with squamous NSCLC will be randomized to receive 1 of the 
following: 
− INCMGA00012 375 mg IV (D1) Q3W with carboplatin AUC 6 (D1) plus 
paclitaxel 200 mg/m2 (D1) OR nab-paclitaxel 100 mg/m2 (D1, D8, D15) Q3W for 
4 cycles followed by INCMGA00012 375 mg IV Q3W until progression 
− Placebo IV (D1) Q3W with carboplatin AUC 6 (D1) plus paclitaxel 200 mg/m2 
(D1) OR nab-paclitaxel 100 mg/m2 (D1, D8, D15) Q3W for 4 cycles followed by 
placebo IV Q3W until progression 
The study design schema for nonsquamous and squamous NSCLC participants is shown in 
Figure 1. 
Treatment with INCMGA00012 or placebo can continue up to a total of 35 cycles, or 
approximately 2 years.  Participants on pemetrexed who complete 35 cycles of INCMGA00012 
or placebo may continue pemetrexed until reaching any other stopping criteria as per package 
insert/SmPc and local guidelines. 
Participants randomized to placebo and chemotherapy who have verification of progressive 
disease by BICR and qualified for the crossover period will have the option to receive 
INCMGA00012 monotherapy 375 mg IV Q3W for up to approximately 2 years (or up to 
35 cycles). 

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A formalin-fixed tumor tissue sample or a fresh tumor biopsy at screening is required for 
participation in the study, and will be used for central laboratory testing of PD-L1 status (TPS) 
using the commercial PD-L1 IHC 22C3 pharmDx (Dako) assay.  Formalin-fixed specimens after 
the participant has been diagnosed with metastatic disease will be preferred for determination of 
PD-L1 status.  Additionally, sites that were previously irradiated should not be used as material 
for a tumor tissue biopsy.  The PD-L1 expression results determined centrally will be used for 
stratification. 
Randomization will be stratified by PD-L1 TPS (ie, < 1%, ≥ 1% to 49%, ≥ 50%), site geographic 
region (ie, East Asia vs non–East Asia), and predominant tumor histology (ie, squamous vs 
nonsquamous). 
Study conduct will be overseen by an eDMC.  An initial safety evaluation will be performed 
after approximately 45 participants have completed the initial cycle of treatment.  An interim 
analysis for OS is planned when approximately 60% of the targeted OS events are expected to 
have occurred.  Details are described in Section 5.5 and Section 10.5. 
Specific procedures to be performed during the study as well as their prescribed times and 
associated visit windows are outlined in Table 3 and Table 4.  The SoA for the crossover period 
is in Table 5. 
4.2. 
Number of Participants 
Approximately 600 participants will be randomized into the study.  Enrollment of participants 
with squamous histology will be limited to < 40% of the total study population in view of the 
differing prognoses between squamous and nonsquamous NSCLC.  Similarly, enrollment of 
participants whose tumors have low PD-L1 expression (ie, TPS < 1%) will be capped at < 30% 
of the total.  See Section 10.1 for more details. 
4.3. 
Overall Study Duration 
The study begins when the first participant signs the ICF.  The end of the study is defined as the 
date of the last visit (last scheduled procedure shown in the SoA) of the last participant in the 
study globally or as the date the last participant withdraws from the study, or is lost to follow-up 
(ie, the participant is unable to be contacted by the investigator).  In EU/EEA, the results of the 
study will be based on the date of the last visit of the last participant in the study globally to 
ensure the results are robust, meaningful, and representative of all multiregions by having 
complete follow-up data determined by the statistical hypotheses for the objectives established.  
Not using the global date could potentially jeopardize the study integrity and invalidate the study 
conclusions due to potential bias, thus potentially violating the statistical analysis assumptions 
described in Section 10. 
A participant is considered to have completed the study if he/she has completed treatment and 
survival follow-up periods of the study. 
If the study is not unblinded as a result of the interim analysis, blinding will be maintained to 
assess OS.  If the primary objective results of OS at the interim analysis are positive, the study 
may be stopped early, in which case participants' study treatment assignment will be unblinded 
and INCMGA00012 monotherapy will offered to those still receiving placebo.  

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If the primary objective results of OS at final analysis are negative, all participants will be 
unblinded and removed from placebo (see Section 10.5 for details on interim analysis).  
All IRBs/ECs and regulatory authorities will be notified first of the decision to unblind.  At this 
time, remaining participants will be treated according to the site's standard of care and monitored 
as per usual standard of care; participants receiving INCMGA00012 may be switched to standard 
of care unless there is a clinical benefit as determined by the investigator.  Efficacy results will 
not be collected in the clinical database and investigators will perform imaging as per local 
standard of care.  Data collection will be limited in scope (eg, no central imaging, no survival 
follow-up period) and will be documented in the site monitoring plan including a reduced 
frequency of site monitoring.  The investigator will be expected to report any SAEs and 
pregnancies as detailed in Section 9.  The remaining participants are considered to be on study 
until a discontinuation criterion is met. 
4.4. 
Study Termination 
The investigator retains the right to terminate study participation at any time, according to the 
terms specified in the study contract.  The investigator is to notify the IRB/EC in writing of the 
study's completion or early termination, send a copy of the notification to the sponsor or 
sponsor's designee, and retain 1 copy for the site study regulatory file. 
The sponsor may terminate the study electively, if required by regulatory decision, or upon 
advice of the eDMC.  If the study is terminated prematurely, the sponsor will notify the 
investigators, the IRBs and IECs, and regulatory bodies of the decision and reason for 
termination of the study.  Reduced data collection activities and procedures as per standard of 
care for remaining participants on study treatment/drug may be performed for participants who 
wish to remain on study if they derive clinical benefit as per investigator.  The eDMC will 
recommend termination of the study if warranted, as described in Section 5.5. 
In addition, further recruitment in the study or at a particular study site(s) may be stopped due to 
insufficient compliance with the Protocol, GCP and/or other applicable regulatory requirements, 
procedure-related problems, or the number of discontinuations for administrative reasons is too 
high. 

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5. 
STUDY POPULATION 
Deviations from eligibility criteria are not allowed because they can potentially jeopardize the 
scientific integrity of the study, regulatory acceptability, and/or participant safety.  Therefore, 
adherence to the criteria as specified in the Protocol is essential.  Prospective approval of 
Protocol deviations to recruitment and enrollment criteria, also known as Protocol waivers or 
exemptions, are not permitted. 
5.1. 
Inclusion Criteria 
Participants are eligible to be included in the study only if all of the following criteria apply: 
1. Ability to comprehend and willingness to sign a written ICF for the study. 
Note: Vulnerable legal adults who are subject to a measure of legal protection, or are 
unable to provide expressed consent to participate, according to applicable local health 
codes and regulations, are excluded. 
2. Is at least 18 years of age on the day of signing the ICF (or as applicable per local country 
requirements). 
3. Has histologically or cytologically confirmed diagnosis of NSCLC (either nonsquamous 
or squamous) that is Stage IV (AJCC v8).  
a. Documentation for absence of driver mutations or gene rearrangements for EGFR, 
ALK, BRAF, and ROS1 if the tumor is of nonsquamous histology. 
Note:  If documentation does not exist for all 4 driver mutations, then archived or 
fresh tumor tissue material must be tested locally, or centrally arranged by the 
sponsor.  Detailed information is found in the Laboratory Manual. 
b. If participant's tumor is known to have a predominantly squamous histology, 
molecular testing for EGFR mutation, ALK, BRAF, and ROS1 translocations will not 
be required, as this is not part of current diagnostic guidelines. 
c. Tumor with mixed histology will be categorized by the predominant cell type; if 
small cell elements are present, the participant is ineligible.  In cases where it is not 
completely known, testing must occur. 
4. No prior systemic treatment for the advanced/metastatic NSCLC with the exception of 
neoadjuvant or adjuvant therapy that did not include a PD-(L)1 directed therapy and 
completed at least 12 months before the development of metastatic disease. 
Note:  Only participants without access (due to inadequate reimbursement, labelling 
restrictions, or any other reason) to the best standard treatment options (eg, an approved 
PD-(L)1 inhibitor in combination with chemotherapy or monotherapy) that, according to 
the investigator, could benefit the participant more can be included in the study.  If the 
best approved and reimbursed standard treatment options become available during the 
study, the participant may discontinue from study treatment if the investigator and the 
participant believe that the participant could benefit more by switching to the approved 
and reimbursed standard treatment.  

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5. Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh 
tumor biopsy after a participant has been diagnosed with metastatic disease, for central 
confirmation of PD-L1 status. 
Note:  Biopsy should be from a tumor site that has not been treated with radiation.  
Formalin-fixed archival specimens after the participant has been diagnosed with 
metastatic disease will be preferred for determination of PD-L1 status (and driver 
mutations if needed) prior to randomization.  
6. Has measurable disease per RECIST v1.1 as determined by local site 
investigator/radiology assessment.  Target lesions situated in a previously irradiated area 
are considered measurable if progression has been demonstrated in such lesions. 
7. Has an ECOG performance status of 0 or 1 at study entry. 
8. Has a life expectancy of at least 3 months before signing the ICF. 
9. Willingness to avoid pregnancy or fathering children based on the criteria below: 
a. Men must agree to take appropriate precautions to avoid fathering children (with at 
least 99% certainty) from screening through 180 days after the last dose of 
chemotherapy and 120 days after the last dose of INCMGA00012 and must refrain 
from donating sperm during this period.  Permitted methods that are at least 99% 
effective in preventing pregnancy (see Appendix A) should be communicated to the 
participants and their understanding confirmed.  
b. A female participant is eligible to participate if she is not pregnant, not breastfeeding, 
and at least 1 of the following conditions applies:  
− Women of childbearing potential must have a negative pregnancy test at 
screening (within 72 hours of the first dose on Day 1).  Women of childbearing 
potential must agree to take appropriate precautions to avoid pregnancy (with at 
least 99% certainty) from screening through 180 days after the last dose of 
chemotherapeutic agents and for at least 120 days after the last dose of 
INCMGA00012.  Permitted methods that are at least 99% effective in preventing 
pregnancy (see Appendix A) should be communicated to the participants and their 
understanding confirmed. 
− Women of nonchildbearing potential (see Appendix A for definitions) are 
eligible. 
10. Has adequate organ function as indicated by the laboratory values in Table 7.  Specimens 
must be collected and reviewed within 10 days prior to the start of study treatment. 

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Table 7: 
Adequate Organ Function Laboratory Values 
Laboratory Parameter 
Laboratory Value 
Hematologic 
a 
Platelets 
≥ 100 × 109/L 
b 
Hemoglobin 
≥ 9 g/dL or ≥ 5.6 mmol/L 
c 
ANC 
≥ 1.5 × 109/L 
Hepatic 
d 
ALT (SGPT) 
≤ 2.5 × ULN OR ≤ 5 × ULN for participants with liver 
metastases 
e 
AST (SGOT) 
≤ 2.5 × ULN OR ≤ 5 × ULN for participants with liver 
metastases 
f 
Total bilirubin 
≤ 1.5 × ULN OR direct bilirubin ≤ ULN for 
participants with total bilirubin levels > 1.5 × ULN. 
If there is no institutional ULN, then direct bilirubin 
must be < 40% of total bilirubin to be eligible.  
Note:  In no case can the total bilirubin exceed 
3 × ULN. 
Renal 
g 
Calculated CrCla  
(glomerular filtration rate can also be 
used in place of CrCl) 
≥ 50 mL/min 
Coagulation 
h 
INR or PT 
≤ 1.5 × ULN unless participant is receiving 
anticoagulant therapy and as long as PT or aPTT is 
within therapeutic range of intended use of 
anticoagulants. 
i 
aPTT or PTT 
≤ 1.5 × ULN unless the participant is receiving 
anticoagulant therapy and as long as PT or aPTT is 
within therapeutic range of intended use of 
anticoagulants. 
a Creatinine clearance should be calculated using the Cockcroft-Gault Method or as per institutional guidelines or 
standard (see Appendix C). 
11. Has had an evaluation by the investigator regarding vaccination against SARS-CoV-2 
before study entry.  
Note: Vaccination before study entry is a strong recommendation, not a requirement. 
Potential participants and the investigator should discuss up-to-date information 
according to national or local vaccination programs and/or oncology professional 
guidelines. 
Note:  Refer to Appendix G for vaccination-related information. 

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5.2. 
Exclusion Criteria 
Participants are excluded from the study if any of the following criteria apply: 
1. Is currently participating and receiving investigational therapy or has participated in a 
study of an investigational agent and received study therapy or used an investigational 
device within 4 weeks of the first dose of treatment. 
2. Received prior systemic cytotoxic chemotherapy, targeted or biological therapy for 
metastatic disease therapy with an anti–PD-1, anti–PD-L1, anti–PD-L2, anti-CD137, or 
anticytotoxic T-lymphocyte–associated antigen-4 antibody, or any other antibody or drug 
specifically targeting T-cell costimulation or checkpoint pathways. 
3. Has clinically significant or impaired cardiac disease including acute myocardial 
infarction, unstable angina, or New York Heart Association Class III or IV congestive 
heart failure within 6 months before Day 1 of study drug administration.  Has other 
clinically significant heart disease (ie, ≥ uncontrolled Grade 3 hypertension) before Day 1 
of study drug administration.  Medically controlled arrhythmia stable on medication for 
at least 14 days before Day 1 of study drug administration is permitted. 
4. Had any major surgery within 3 weeks of the first dose of study treatment. 
5. Received thoracic radiation therapy of > 30 Gy within 6 months of the first dose of study 
treatment.  
Note:  Participants must have recovered from all radiation-related toxicities to Grade 1 or 
less, not require corticosteroids, and not have had radiation pneumonitis.  A 1-week 
washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS 
disease. 
6. Has a history of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may 
receive cisplatin, paclitaxel, or nab-paclitaxel. 
7. Has untreated CNS metastases and/or carcinomatous meningitis identified either on the 
baseline brain imaging obtained during the screening period OR identified before signing 
the ICF (ie, without evidence of progression by imaging during screening). 
Note:  Participants whose brain metastases have been treated may participate provided 
they show radiographic stability (defined as 2 brain images, same imaging modality, both 
of which are obtained after treatment to the brain metastases; these imaging scans should 
be obtained at least 4 weeks apart and show no evidence of intracranial progression).  In 
addition, any neurologic symptoms that developed either as a result of the brain 
metastases or their treatment must have returned to baseline or resolved.  Any steroids 
administered as part of this therapy must be completed at least 3 days before study 
treatment. 
8. Evidence of interstitial lung disease or history of interstitial lung disease, or has history of 
noninfectious pneumonitis that required systemic steroids or has active pneumonitis.  

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9. Has an active infection requiring IV systemic therapy or active tuberculosis. 
Note:  If required by country or local regulations to be tested for COVID-19 during 
screening, a participant should be excluded if they have a positive test result for 
SARS-CoV-2 infection until both the retesting result is negative and clinical recovery is 
obtained. 
10. Has symptomatic ascites or pleural effusion.  A participant who is clinically stable 
following treatment for these conditions (including therapeutic thoraco- or paracentesis) 
is eligible. 
11. Has known active HBV or HCV defined as follows (testing must be performed to 
determine eligibility): 
a. HBV DNA must be undetectable and HBsAg negative at screening visit. 
b. Active HCV is defined as a positive HCV antibody result and quantitative HCV-RNA 
results greater than the lower limits of detection of the assay. 
Note:  Participants who have had definitive treatment for HCV are permitted if 
HCV-RNA is undetectable. 
12. Has a known history of HIV infection.  HIV testing is not required unless mandated by 
the local health authority, or local regulations. 
Note:  HIV testing is required in Czech Republic and South Africa. 
13. Has a known history of an additional malignancy, except if the participant has undergone 
potentially curative therapy with no evidence of that disease recurrence for 3 years since 
initiation of that therapy. 
Note:  The time requirement for no evidence of disease for 3 years does not apply to the 
NSCLC for which a participant is enrolled in the study.  The time requirement also does 
not apply to participants who underwent successful definitive resection of basal cell 
carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, 
in situ cervical cancer, other noninvasive or indolent malignancies, or other in situ 
cancers. 
14. Has had an allogeneic tissue/solid organ transplant. 
15. Previously had a severe hypersensitivity reaction to treatment with a monoclonal 
antibody or has a known sensitivity to any component of INCMGA00012 or as 
applicable, to carboplatin, cisplatin, paclitaxel, nab-paclitaxel, or pemetrexed. 
16. Is unable to interrupt aspirin or other NSAIDS, other than an aspirin dose ≤ 1.3 g per day, 
for a 5-day period (8-day period for long acting agents such as piroxicam).   
Note:  This exclusion is for potential participants with nonsquamous NSCLC. 
17. Is unable or unwilling to take folic acid or vitamin B12 supplementation. 
Note:  This exclusion is for potential participants with nonsquamous NSCLC. 

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18. Has an active autoimmune disease that has required systemic treatment in past 2 years 
(ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).  
Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement 
therapy for adrenal or pituitary insufficiency) is allowed. 
19. Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study 
treatment or receiving any other form of immunosuppressive medication. 
a. Corticosteroid use after randomization is allowed for management of AEs, SAEs, as a 
premedication for IV contrast, or if considered necessary for a participant's welfare. 
b. Participants who receive daily steroid replacement therapy ≤ 10 mg prednisone or 
equivalent are exempt. 
c. Participants with asthma that requires intermittent use of bronchodilators, inhaled 
steroids, or local steroid injections may participate (are allowed to participate). 
d. Participants using topical, ocular, intra-articular, or intranasal steroids (with minimal 
systemic absorption) may participate. 
20. Has received a live vaccine within 30 days before the first dose of study treatment (and 
until 90 days after last dose of study drug).   
a. Examples of live vaccines include, but are not limited to, the following:  measles, 
mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and 
typhoid vaccine.  Seasonal influenza vaccines that do not contain live virus vaccines 
are allowed. 
21. Current use of any prohibited medication as described in Section 6.6.3. 
22. Has a history or current evidence of any condition including psychiatric or substance 
abuse disorders, therapy, or laboratory abnormality that might confound the results of the 
study, interfere with the participant's ability to participate, or cooperate, for the full 
duration of the study, or is not in the best interest of the participant to participate, in the 
opinion of the treating investigator. 
5.3. 
Lifestyle Considerations 
No restrictions are required. 
5.3.1. 
Meals and Dietary Restrictions 
Participants should maintain a normal diet unless modifications are required to manage an AE 
such as diarrhea, nausea, or vomiting.  
5.3.2. 
Use in Nursing Women 
It is unknown whether INCMGA00012 is excreted in human milk.  Since many drugs are 
excreted in human milk, and because of the potential for serious adverse reactions in the nursing 
infant, participants who are breast-feeding are not eligible for enrollment. 

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5.3.3. 
Use in Pregnancy 
If a female participant inadvertently becomes pregnant while on treatment in this study, the 
participant will be immediately removed from the study.  Participants should be informed that 
taking the study treatment may involve unknown risks to the fetus (unborn baby) if pregnancy 
were to occur during the study.  The site will contact the participant frequently 
(ie, approximately monthly) to document the participant's status until the pregnancy has been 
completed or terminated, and until follow-up to the first well-baby visit to monitor the child's 
and mother's safety.  For details and pregnancy reporting requirements, see Section 9.7. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not subsequently randomized to study treatment/entered in the study. 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened 1 time after consultation with the sponsor and will receive a new participant number.  
Participants who rescreen must reconsent if more than 42 days have elapsed from original 
consent date. 
Tests with results that fail eligibility requirements may be repeated once during screening if the 
investigator believes the result to be in error.  For screening visit procedures refer to 
Section 8.1.2. 
5.5. 
External Data Monitoring Committee 
This study will use an eDMC to monitor safety and efficacy at the planned analyses (see 
Section 10.5) and as needed throughout the duration of the study as specified in the eDMC 
charter.  There will be 1 planned interim analysis of OS and a final analysis of OS.  The voting 
members of the eDMC are external to the sponsor.  The members of the eDMC will not be 
involved with the study in any other way and will have no competing interests that could affect 
their roles with respect to the study.  The eDMC will assess the initial safety of the 
INCMGA00012 plus chemotherapy treatment arm vs the placebo plus chemotherapy treatment 
arm when approximately 45 participants have been randomized and received at least 1 cycle of 
study treatment, or after 6 months of enrollment, whichever occurs first. 
Specific details regarding composition, responsibilities, and governance, including the roles and 
responsibilities of the various members and the sponsor, and protocol team; and requirements for 
and proper documentation of eDMC reports, minutes, and recommendations will be described in 
the eDMC charter. 
5.6. 
Replacement of Participants 
A participant who discontinues from study treatment or withdraws from the study will not be 
replaced at any time during this study. 

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6. 
STUDY TREATMENT 
6.1. 
Study Treatments Administered 
Table 8 presents the study drug and study treatment information.  
INCMGA00012 or placebo will be provided centrally by the sponsor, and commercial and local 
supply of chemotherapy agents will be used as permissible per regulatory requirements, or 
centrally by the sponsor. 

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Table 8: 
Study Drug and Treatment Information 
Study Drug/ 
Treatment Name: 
INCMGA00012/ 
placeboa 
Carboplatinb 
Cisplatinb 
Pemetrexedb 
Nab-paclitaxelb 
Paclitaxelb 
Dose 
Formulation(s): 
Solution, 25 mg/mL 
in a glass vial for 
single use 
Solution 
Solution 
Solution 
Powder for infusion 
Powder for infusion  
Solution 
Source: 
Sponsor 
Locally by the study site, or designee as permissible per regulatory requirements, or centrally by the sponsor 
Dose Frequency: 
375 mg Q3W 
For nonsquamous: 
AUC 5 mg/mL × min 
Q3W 
 
For squamous: 
AUC 6 mg/mL × min 
Q3W 
75 mg/m2 Q3W 
500 mg/m2 Q3W 
100 mg/m2 Q1W 
200 mg/m2 Q3W 
Use: 
Experimental 
Part of treatment of 
cancer/SOC 
Part of treatment 
of cancer/SOC 
Part of treatment of 
cancer/SOC 
Part of treatment of 
cancer/SOC 
Part of treatment of 
cancer/SOC 
Route of 
Administration: 
IV infusion 
IV infusion  
IV infusion  
IV infusion  
IV infusion  
IV infusion 
Study Treatment 
Period: 
Day 1 of each 21-day 
cycle for up to 
35 cycles 
Day 1 of each 21-day cycle 
for 4 cycles 
Day 1 of each 
21-day cycle for 
4 cycles 
Day 1 of each 21-day 
cycle 
Days 1, 8, and 15 of 
each 21-day cycle for 
4 cycles 
Day 1 of each 21-day 
cycle for 4 cycles 
a Study drug (INCMGA00012/placebo) to be administered before chemotherapy in the blinded period of the study. 
b Study treatment (INCMGA00012/placebo plus chemotherapy) 

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For any commercially available product that is provided by the study site, or designee, every 
attempt will be made to source these supplies from a single lot/batch number.  The study site is 
responsible for recording the lot number or equivalent identifier, manufacturer, and expiry date 
for any locally purchased product as per local guidelines unless otherwise instructed by the 
sponsor.  Minimally, the lot number or equivalent identifier will be collected in the clinical 
database. 
The investigator shall take responsibility for and shall take all steps to maintain appropriate 
records and ensure appropriate supply, storage, handling, and distribution and usage of study 
treatments in accordance with the Protocol and any applicable laws and regulations. 
6.1.1. 
Timing of Dose Administration 
Study treatment should be administered on Day 1 of each cycle after all procedures have been 
completed.  For participants who receive nab-paclitaxel, study treatment should be administered 
on Days 1, 8 (± 1 day), and 15 (± 1 day) of each cycle after all procedures have been completed.  
Study treatment can be administered ± 3 days of the targeted Day 1 for each cycle except Cycle 1 
where study treatment can only be administered + 3 days of the targeted Day 1. 
6.1.1.1. 
INCMGA00012/Placebo 
INCMGA00012 or placebo will be administered in a blinded fashion by IV infusion over 
30 minutes (ie, 25 to 45 minutes) on Day 1 of each 21-day cycle.  INCMGA00012 or placebo 
infusion should precede that of chemotherapy. 
For the first 4 cycles, after infusion of INCMGA00012, administration of combination doublet 
chemotherapy will follow. As with any monoclonal antibody, the risk of IRRs is greatest with 
the first few infusions.  For the first 4 cycles, participants will be observed in the clinic for 
several hours since the 2 chemotherapy agents will be given after INCMGA00012/placebo is 
administered.  The recommended postinfusion observation period for the first cycles provides 
sufficient time for monitoring of IRRs in this study.  Premedication with antipyretics and/or 
histamine blockers should be considered for participants who have had previous systemic 
reactions to protein product infusions or when recommended by institutional policy. 
Participants may receive INCMGA00012 or placebo for up to 2 years (or 35 administrations of 
INCMGA00012/placebo) until unacceptable toxicity, disease progression, investigator's 
decision, pregnancy, withdrawal of consent, or study termination. 
Details on excipients, preparation, storage, and administration of the INCMGA00012/placebo 
infusion are provided in the Pharmacy Manual and the IB. 
6.1.2. 
For Participants With Nonsquamous Non–Small Cell Lung Cancer 
6.1.2.1. 
Carboplatin 
Carboplatin AUC 5 mg/mL × minute will be administered as an IV infusion over 15-60 minutes 
for the first 4 cycles immediately after pemetrexed as per local practice and labels.  Time 
windows for infusion may be modified based on local labels/SmPCs or institutional guidelines. 

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Carboplatin dose is not to exceed 750 mg.  The carboplatin dose should be calculated using the 
Calvert formula as follows: 
Total dose (mg) = (target AUC) × (CrCl + 25). 
The CrCl used in the Calvert formula should not exceed 125 mL/minute. 
Maximum dose (mg) = target AUC 5 (mg ∙ min/mL) × (125 + 25) = 5 × 150 mL/min = 750 mg. 
6.1.2.2. 
Cisplatin 
Cisplatin 75 mg/m2 should be infused approximately 30 minutes after the pemetrexed infusion 
for the first 4 cycles and should be immediately preceded and followed by hydration procedures 
and administered according to local practice and labels.  Time windows for infusion may be 
modified based on local labels/SmPCs or institutional guidelines. 
6.1.2.3. 
Pemetrexed 
Pemetrexed 500 mg/m2 will be administered as an IV infusion over 10 minutes on Day 1 of each 
cycle until progression or unacceptable toxicity.  All participants should receive the appropriate 
supplementation of vitamin B12 and folic acid and corticosteroid prophylaxis as listed below: 
• Folic acid 400-1000 μg orally:  at least 5 doses of folic acid must be taken during the 
7 days preceding the first dose of pemetrexed, and folic acid dosing must continue 
during the full course of therapy and for 21 days after the last dose of pemetrexed. 
• Vitamin B12 1000 μg intramuscular injection in the week preceding the first dose of 
pemetrexed and once every 3 cycles thereafter.  Subsequent vitamin B12 injections 
may be given the same day as pemetrexed administration. 
• Dexamethasone prophylaxis 4 mg orally BID (or equivalent) must be taken the day 
before, day of, and day after pemetrexed administration.  Higher or additional doses 
are permitted for antiemetic prophylaxis during Cycles 1 through 4 but are not to 
exceed doses in MASCC/ESMO guidelines (Rolia et al 2016; see Appendix B). 
6.1.3. 
For Participants With Squamous Non–Small Cell Lung Cancer 
6.1.3.1. 
Paclitaxel 
Paclitaxel 200 mg/m2 will be administered as an IV infusion over 3 hours on Day 1 for the first 
4 cycles as per local practice and labels.  All participants should be premedicated with oral or IV 
steroids and histamine blockers according to the approved label and/or standard practice.  Time 
windows for infusion may be modified based on local labels/SmPCs or institutional guidelines. 
Additional premedications should be administered as per standard practice.  Paclitaxel should be 
completely administered before initiating the carboplatin dose. 
6.1.3.2. 
Nab-Paclitaxel 
Nab-paclitaxel (investigator's choice of either paclitaxel or nab-paclitaxel) 100 mg/m2 will be 
administered as an IV infusion over 30 minutes on Days 1, 8, and 15 for the first 4 cycles as per 
local practice and approved labels.  Time windows for infusion may be modified based on local 

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labels/SmPCs or institutional guidelines.  Nab-paclitaxel should be completely administered 
before initiating the carboplatin dose. 
6.1.3.3. 
Carboplatin 
Carboplatin AUC 6 mg/mL × minute will be administered as an IV infusion over 15 to 
60 minutes on Day 1 for the first 4 cycles immediately after paclitaxel or nab-paclitaxel as per 
local practice and labels.  Time windows for infusion may be modified based on local 
labels/SmPCs or institutional guidelines.  The carboplatin dose should not exceed 900 mg.  The 
carboplatin dose should be calculated using the Calvert formula as follows: 
Total dose (mg) = (target AUC) × (CrCl + 25). 
The CrCl used in the Calvert formula should not exceed 125 mL/minute. 
Maximum dose (mg) = target AUC 6 (mg ∙ min/mL) × (125 + 25) = 6 × 150 mL/min = 900 mg. 
6.1.3.4. 
Antiemetic Therapy for Nonsquamous Non–Small Cell Lung Cancer 
Antiemetic therapy should follow MASCC/ESMO guidelines and should for the first 4 cycles 
include a 5-HT3 receptor antagonist, dexamethasone (or equivalent), and/or aprepitant (or 
equivalent) as per MASCC/ESMO Antiemetic Guidelines (Rolia et al 2016; see Appendix B). 
6.2. 
Preparation, Handling, and Accountability 
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatments received and any discrepancies are reported and 
resolved before use of the study treatment. 
Only participants enrolled in the study may receive study treatment, and only authorized site 
staff may supply or administer study treatment.  All study treatment must be stored in a secure, 
environmentally controlled, and monitored (manual or automated) area in accordance with the 
labeled storage conditions with access limited to the investigator and authorized site staff. 
The investigator (or designee) is responsible for study treatment accountability, reconciliation, 
and record maintenance.  Inventory and accountability records must be maintained and readily 
available for inspection by the study monitor and are open to inspection at any time by any 
applicable regulatory authorities.  The investigator or designee must maintain records that 
document: 
• Delivery of study drug(s) to the study site. 
• Inventory of study drug(s) at the site. 
• Lot numbers and/or vial numbers (as applicable) of study drug used to prepare the 
infusion solution. 
The investigational product must be used only in accordance with the Protocol.  The investigator 
will also maintain records adequately documenting that the participants were administered the 
specified study drug.  These records should include dates, quantities, and any available batch or 
serial numbers or unique code numbers assigned to the investigational product and study 
participants. 

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Completed accountability records will be archived by the site.  The investigator or designee will 
be expected to collect and retain all used, unused, and partially used containers of study drug 
until verified by the study monitor (unless otherwise agreed to by the sponsor).  At the 
conclusion of the study, the investigator or designee will oversee shipment of any remaining 
study drug back to the sponsor or its designee for destruction according to institutional standard 
operating procedures.  If local procedures mandate on-site destruction of investigational supply, 
the site should (where local procedures allow) maintain the investigational supply until the study 
monitor inspects the accountability records in order to evaluate compliance and accuracy of 
accountability by the investigative site.  At sites where the study drug is destroyed before site 
monitor's inspection, the monitors rely on documentation of destruction per the site SOP. 
Relevant information on the handling and storage of the study drug information is provided in 
the Pharmacy Manual. 
Standard chemotherapeutic agents (cisplatin, carboplatin, pemetrexed, paclitaxel, or 
nab-paclitaxel) will be prepared and administered as per the approved product label. 
6.3. 
Measures to Minimize Bias:  Randomization and Blinding 
All participants will be centrally assigned to study treatment using an IRT/IVRS.  Full details 
will be provided in the IRT/IVRS Manual. 
Study treatment will be dispensed at the study visits summarized in the SoA (see Table 3 through 
Table 5). 
Centralized randomization numbers within each stratum will be created for treatment 
assignment.  Participants will be assigned to study treatment in accordance with the 
randomization schedule.  Participants, investigators, the sponsor, and the study team will be 
blinded to treatment assignment.  See emergency unblinding procedures in Section 9.6. 
6.4. 
Study Treatment Compliance 
The site personnel must emphasize compliance with all study-related treatments to the 
participant.  Appropriate steps should be taken to optimize compliance during the study.  
Compliance with each study drug will be calculated by the sponsor based on the study treatment 
infusion records and monitored by the sponsor/designee. 
6.5. 
Dose Modifications 
6.5.1. 
Dose Modifications for Immune-Related Toxicity 
Adverse events of a potential immunologic etiology, or irAEs, may be defined as AEs of 
unknown etiology, associated with drug exposure, and consistent with an immune phenomenon.  
INCMGA00012/placebo treatment may be interrupted or discontinued due to toxicity.  Dose 
modification of INCMGA00012/placebo is not allowed.  Instructions for management in the 
event of irAEs are outlined in Table 9. 
Immune-related AEs may be predicted based on the nature of the compounds, their mechanism 
of action, and reported experience with immunotherapies that have a similar mechanism of 
action.  Special attention should be paid to AEs that may be suggestive of potential irAEs.  

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Should an irAE be suspected, efforts should be made to rule out neoplastic, infectious, metabolic, 
toxins, or other etiologies before attributing the irAE to an immune-related response.  An irAE 
can occur shortly after the first dose or several months after the last dose of treatment. 
Algorithms for evaluation of selected immune toxicities that have previously been attributed to 
PD-1 inhibitors and management guidelines for irAEs not detailed elsewhere in the Protocol 
should follow the ASCO or ESMO Clinical Practice Guidelines (Haanen et al 2017, 
NCCN 2021a, Schneider et al 2021). 
If a dose interruption is necessary for management of treatment-related TEAEs, 
INCMGA00012/placebo will be reinitiated at the dose at which it was interrupted.  
INCMGA00012/placebo may be interrupted for a maximum of 12 weeks from the last infusion.  
Decisions regarding these dose interruptions and restarts will be made according to Table 9 and, 
when needed, jointly by the investigator and medical monitor on a case-by-case basis. 
INCMGA00012/placebo may be interrupted for situations other than treatment related AEs such 
as medical surgical events (eg, planned hip surgery) or logistical reasons not related to study 
treatment.  Participants should be back on study treatment within 3 weeks of the scheduled 
interruption, unless otherwise discussed with the sponsor.  The reason for interruption should be 
documented in the participant's medical records and eCRFs. 

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Table 9: 
Dose Modifications for Adverse Events of INCMGA00012/Placebo and Toxicity Management Guidelines for 
Immune-Related Adverse Events 
Immune-Related Adverse Event 
Toxicity Grade or Conditions 
(CTCAE v5.0) 
Action Taken With Study Drug 
AE Management With Corticosteroid and/or Other 
Supportive Carea Therapies 
Pneumonitis 
Grade 1 
No action. 
None. 
Grade 2 
Withhold until ≤ Grade 1. 
• Administer systemic corticosteroids per local practice 
followed by taper. 
• Evaluate participants with suspected pneumonitis with 
radiographic imaging and initiate corticosteroid treatment. 
• Add prophylactic antibiotics for opportunistic infections. 
Grade 3 or 4 or recurrent Grade 2 
Permanently discontinue. 
Diarrhea/colitis 
Grade 1 
No action. 
None. 
Grade 2 or 3 
Withhold until ≤ Grade 1. 
• Consider prompt initiation of standard antidiarrheal agents 
and other necessary supportive care as needed (eg, oral 
and/or IV fluids). 
• Administer systemic corticosteroids per local practice 
followed by taper. 
• Consider prophylactic antibiotics per local practice. 
• Consider gastrointestinal consultation and performing 
endoscopy to rule out colitis. 
• Consider stool sample evaluation to rule out 
Clostridioides difficile and infectious etiologies. 
Grade 4 or recurrent Grade 3 
Permanently discontinue. 
AST/ALT elevation and/or 
increased total bilirubin/hepatitis 
Grade 1 
No action. 
None. 
Grade 2 ALT or AST increase 
OR 
Total bilirubin increases to more 
than 1.5 and up to 3 times ULN 
Withhold until ≤ Grade 1. 
• Administer systemic corticosteroids per local practice 
followed by taper. 
• Consider monitoring liver enzymes weekly (or more 
frequently) until liver enzyme value returns to baseline or 
is stable. 
• Consider monitoring total bilirubin, direct bilirubin and 
alkaline phosphatase weekly (or more frequently). 
Grade 3 or 4 ALT or AST increase 
OR 
in participants with liver 
metastases with baseline Grade 2 
elevation of AST or ALT, hepatitis 
with AST or ALT increases ≥ 50% 
and lasts ≥ 1 week 
OR 
Total bilirubin increases to more 
than 3 times ULN 
Permanently discontinue. 

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Table 9: 
Dose Modifications for Adverse Events of INCMGA00012/Placebo and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related Adverse 
Event 
Toxicity Grade or Conditions 
(CTCAE v5.0) 
Action Taken With Study Drug 
AE Management With Corticosteroid and/or Other 
Supportive Carea Therapies 
Endocrinopathies 
• Adrenal insufficiency 
• Hypothyroidism 
• Hyperthyroidism 
• Type 1 diabetes mellitus 
• Hyperglycemia 
Grade 1 adrenal insufficiency 
No action. 
None. 
Grade 2 adrenal insufficiency  
Withhold until ≤ Grade 1 or 
otherwise clinically stable. 
Initiate treatment with hormone replacement as clinically 
indicated. 
Grades 3 or 4 adrenal insufficiency 
Withhold until ≤ Grade 1 after 
corticosteroid taper to ≤ 10 mg/day 
prednisone or equivalent or is 
otherwise clinically stable. 
Initial dose of 1 to 2 mg/kg/day prednisone or equivalent 
followed by a taper and hormone replacement as clinically 
indicated. 
Grades 1 and 2 
No action. 
None. 
Grades 3 or 4 hypothyroidism 
Withhold until ≤ Grade 1 or is 
otherwise clinically stable. 
Initiate thyroid replacement hormones (eg, levothyroxine or 
liothyronine) per standard of care. 
Grades 3 or 4 hyperthyroidism 
Withhold until ≤ Grade 1 or is 
otherwise clinically stable. 
Initiate symptomatic management. 
Grades 3 or 4 type 1 diabetes 
mellitus (or hyperglycemia) 
Withhold until ≤ Grade 1 or is 
otherwise clinically stable. 
Initiate treatment with antihyperglycemics or insulin as 
clinically indicated. 
Endocrinopathies (continued) 
• Hypophysitis 
Grade 1  
No action. 
None. 
Grade 2 (asymptomatic) 
Withhold until ≤ Grade 1. 
 
May restart study drug treatment 
after controlled by hormone 
replacement therapy. 
Administer hormonal replacement 
Grade 2 (symptomatic; eg, 
headaches, visual disturbances) 
Withhold until ≤ Grade 1. 
 
May restart study drug after 
controlled with hormone 
replacement therapy, if indicated, 
and steroid taper is complete. 
• Administer corticosteroids at initial dose of 1 to 2 mg/kg/day 
prednisone or equivalent followed by a taper, and initiate 
other hormonal replacement as clinically indicated.  
• Consult with endocrinologist as needed. 

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Table 9: 
Dose Modifications for Adverse Events of INCMGA00012/Placebo and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related Adverse 
Event 
Toxicity Grade or Conditions 
(CTCAE v5.0) 
Action Taken With Study Drug 
AE Management With Corticosteroid and/or Other 
Supportive Carea Therapies 
Endocrinopathies (continued) 
• Hypophysitis (continued) 
Grade 3 or 4 (symptomatic) 
• Permanent discontinuation 
should occur if after withholding 
study drug, the toxicity does not 
resolve to ≤ Grade 1 within 
12 weeks after last dose of study 
drug, or if corticosteroid dose 
cannot be reduced to ≤ 10 mg 
prednisone or equivalent per day 
within 12 weeks. 
• Permanent discontinuation of 
study drug should take place 
earlier at the investigator's 
discretion if corticosteroids 
and/or hormone replacement 
therapy cannot balance the 
participant's pituitary function. 
• Administer corticosteroids at initial dose of 1 to 2 mg/kg/day 
prednisone or equivalent followed by a taper and initiate 
other hormonal replacement as clinically indicated. 
• Consult with endocrinologist as needed. 
Nephritis and renal dysfunction 
Grade 1 
No action. 
None. 
Grade 2 or 3 increased blood 
creatinine 
Withhold until ≤ Grade 1. 
Administer corticosteroids per local practice followed by 
taper. 
Grade 4 increased blood creatinine 
Permanently discontinue. 
Skin (eg, SJS, TEN) 
Grade 1 
No action. 
None. 
Grade 2 
No action. 
Manage with topical steroids with or without drug 
interruption. 
Grade 3b or persistent Grade 2 
(≥ 2 weeks) or suspected SJSc 
Withhold until ≤ Grade 1 after 
corticosteroid taper to ≤ 10 mg/day 
prednisone or equivalent. 
• Administer corticosteroids per local practice followed by 
taper. Additionally, oral histamine blocker such as 
diphenhydramine or famotidine (per institutional 
preference) may be utilized as needed. 
• Refer timely to dermatology consult if no resolution with 
these measures. 
• Refer timely to dermatology consult if SJS or TEN is 
suspected. 
Grade 4 or confirmed SJSc or TENd 
Permanently discontinue. 
• Initial dose of 1 to 2 mg/kg/day prednisone or equivalent 
followed by a taper. 
• Refer timely to dermatology consult. 

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Table 9: 
Dose Modifications for Adverse Events of INCMGA00012/Placebo and Toxicity Management Guidelines for 
Immune-Related Adverse Events (Continued) 
Immune-Related Adverse 
Event 
Toxicity Grade or Conditions 
(CTCAE v5.0) 
Action Taken With Study Drug 
AE Management With Corticosteroid and/or Other 
Supportive Carea Therapies 
Myocarditis 
Grade 2 
• Depending on severity of 
symptoms, withhold until 
symptoms fully resolve and 
management with corticosteroids 
is complete. 
• Permanent discontinuation of 
study drug may take place 
earlier at the investigator's 
discretion. 
• Treatment with systemic corticosteroids should be initiated 
(initial dose of 1-2 mg/kg/day of prednisone or equivalent).  
Taper as appropriate. 
• Refer timely to cardiology consult. 
• Management of cardiac symptoms according to standard of 
care and with guidance from cardiology.  Consider cardiac 
MRI and myocardial biopsy for diagnosis. 
Grades 3 or 4 
Permanently discontinue. 
Important nervous system events 
(eg, Guillain-Barre syndrome, 
autoimmune encephalitis, 
myasthenia gravis, autonomic 
neuropathy, or transverse 
myelitis) 
Grade 2 
Withhold until ≤ Grade 1. 
• Neurology consultation is recommended for all neurologic 
irAEs ≥ Grade 2. 
• Treatment with systemic corticosteroids should be initiated 
(initial dose of 1-2 mg/kg/day of prednisone or equivalent).  
Taper as appropriate. 
• For Grade 2 transverse myelitis, consider permanent 
discontinuation. 
• Manage symptoms according to standard of care and with 
guidance from neurology. 
Grades 3 or 4 
Permanently discontinue. 
All other irAEs 
Grades 2 or 3 based on severity and 
type of reaction 
Withhold until ≤ Grade 1. 
• Based on severity of AE, administer corticosteroids. 
• Ensure adequate evaluation to confirm etiology or exclude 
other causes. 
Recurrent Grade 3 or persistent 
Grades 2 or 3 
Permanently discontinue. 
Grade 4e (excluding 
endocrinopathies) 
Permanently discontinue. 
a As general instructions the following should be followed:  If treatment-related toxicity does not resolve to Grade 0-1 within 12 weeks after last dose of study drug, or if 
corticosteroid dosing cannot be reduced to ≤ 10 mg prednisone or equivalent per day within 12 weeks, study drug should be permanently discontinued.  Severe and 
life-threatening irAEs should be treated with IV corticosteroids followed by oral steroids. Other immunosuppressive treatment should begin if irAEs are not controlled by 
corticosteroids. 
b Participants with Grade 3 rash in the absence of desquamation, with no mucosal involvement, not requiring systemic steroids, and resolving or improving to ≤ Grade 1 within 
14 days do not have to interrupt study drug. 
c Grade 3 SJS is defined as skin sloughing covering < 10% BSA with associated signs (eg, erythema, purpura, epidermal detachment, mucous membrane detachment).  Grade 4 
SJS is defined as skin sloughing covering 10% to 30% BSA with associated signs (eg, erythema, purpura, epidermal detachment, mucous membrane detachment). 
d Toxic epidermal necrolysis is Grade 4 by definition and is defined as skin sloughing covering ≥ 30% BSA with associated symptoms (eg, erythema, purpura, epidermal 
detachment). 
e If Grade 4 lipase/amylase elevation is asymptomatic, and abdominal imaging suggests no pathology, then study drug administration may continue with medical monitor 
approval. 

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6.5.1.1. 
Guidelines for Management of Suspected Infusion Reactions 
Infusion or hypersensitivity reactions may be observed with administration of any foreign 
protein.  Premedication with an antipyretic (ie, acetaminophen, paracetamol, or equivalent) and a 
histamine blocker should be considered for participants who have had previous systemic 
reactions to protein product infusions or when recommended by institutional policy. 
Toxicity management guidelines for suspected infusion reactions are provided in Table 10. 
Table 10: 
Guidelines for Management of Suspected Infusion Reactions 
Grade 
Descriptiona 
Treatment 
Subsequent Infusions 
1 
Mild reaction; Interrupt or slow the 
rate of infusion; intervention not 
indicated. 
Monitor vital signs closely until 
medically stable. 
Premedication with an antipyretic 
(acetaminophen/paracetamol or 
equivalent) and a histamine blocker 
should be considered for participants 
who have had previous systemic 
reactions to protein product infusions 
or when recommended by institutional 
policy. 
Prophylaxis with an antipyretic and a 
histamine blocker is recommended in 
subsequent INCMGA00012 or 
placebo treatment cycles if the 
participant develops an IRR in a prior 
cycle. 
2 
Requires infusion interruption but 
responds promptly to symptomatic 
treatment (eg, histamine blocker, 
NSAIDS, narcotics, IV fluids); 
prophylactic medications indicated for 
≤ 24 hours. 
First occurrence:  Stop infusion and 
initiate appropriate medical measures 
(eg, IV fluids, histamine blocker, 
NSAIDS, antipyretics, narcotics, per 
institutional preferences). 
Monitor vital signs until medically 
stable. 
If symptoms resolve within 1 hour, 
infusion may be resumed at 50% of 
the original infusion rate. 
Subsequent occurrences (after 
recommended prophylaxis):  
Permanently discontinue study 
treatment. 
Premedicate at least 30 minutes before 
infusion with histamine blocker 
(diphenhydramine 50 mg PO or 
equivalent) and an antipyretic 
(acetaminophen or equivalent). 
Additional supportive measures may 
be acceptable (per institutional 
preference) and may be discussed with 
medical monitor. 
Next infusion should start at 50% of 
the original infusion rate.  If no 
reaction, rate of infusion can be 
increase by 25% every 15 minutes 
until a rate of 100% has been reached.  
Subsequent infusions can begin at 
100%. 
3 or 4 
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. 
Stop infusion and initiate appropriate 
medical therapy (eg, IV fluids, 
histamine blocker, NSAIDS, 
antipyretics, narcotics, oxygen, 
pressors, epinephrine, corticosteroids, 
per institutional preferences). 
Monitor vital signs frequently until 
medically stable.  Hospitalization may 
be indicated. 
Permanently discontinue study 
treatment. 
Note for NCI CTCAE (v5.0) Grade 3 
IRR:  if rapidly responsive to 
symptomatic medication and/or to 
brief interruption of infusion, study 
drug does not need to be permanently 
discontinued. 
a Per NCI CTCAE v5.0, appropriate resuscitation equipment should be available at the bedside and a physician readily available 
during the period of study treatment administration. 

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6.5.2. 
Dose Modifications for Nonimmune (Chemotherapy-Related) Toxicity 
Dose levels for modifications of chemotherapy agents used for participants with nonsquamous 
and squamous NSCLC are summarized in Table 11. 
Table 11: 
Dose Levels for Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, and 
Carboplatin 
For Nonsquamous NSCLC 
Dose Level 0 
Dose Level -1 
Dose Level -2 
Dose Level -3 
Cisplatin 
75 mg/m2 
56 mg/m2 
(25% decrease) 
38 mg/m2 
(25% decrease) 
Discontinue 
Carboplatin 
AUCa 5 
maximum dose 
750 mg 
AUCa 3.75 
maximum dose  
(25% decrease) 
AUCa 2.5 
maximum dose 
(25% decrease) 
Discontinue 
Pemetrexed 
500 mg/m2 
375 mg/m2 
(25% decrease) 
250 mg/m2 
(25% decrease) 
Discontinue 
For Squamous NSCLC 
Dose Level 0 
Dose Level -1 
Dose Level -2 
Dose Level -3 
Paclitaxel 
200 mg/m2 
160 mg/m2 
(20% decrease) 
120 mg/m2 
(20% decrease) 
Discontinue 
Carboplatin 
AUCa 6 
maximum dose 
900 mg 
AUCa 4.5 
maximum dose 
(25% decrease) 
AUCa 3 
maximum dose 
(25% decrease) 
Discontinue 
a Area under the curve, mg × min/mL. 
6.5.2.1. 
Chemotherapy Dose Modification for Hematological and Nonhematological 
Toxicities 
Main chemotherapy hematological and nonhematological toxicities are described below in 
Table 12 through Table 15 for recommended dose modification.  These recommendations are a 
guide and do not replace the investigator's judgment when applicable local label 
recommendations are not fully described, or when there are immediate local label updates 
available.  If a participant experiences several toxicities and there are conflicting 
recommendations, the most conservative dose adjustment recommended should be followed 
(dose reduction appropriate to the most severe toxicity). 

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Table 12: 
Recommended Dose Modifications of Pemetrexed, Cisplatin, and 
Carboplatin Chemotherapy Agents for Hematological Toxicity 
Platelets 
ANC 
Pemetrexed 
Cisplatin 
Carboplatin 
Dose level from Table 11 
≥ 50,000/μL AND 
≥ 500/μL 
DL0 
DL0 
DL0 
≥ 50,000/μL AND 
< 500/μL 
DL-1 
DL-1 
DL-1 
< 50,000/μL without 
bleeding AND 
ANY 
DL-1 
DL-1 
DL-1 
< 50,000/μL with Grade ≥ 2 
bleeding AND 
ANY 
DL-2 
DL-2 
DL-2 
ANY AND 
< 1,000/μL + fever 
≥ 38.5°C (101°F) 
DL-1 
DL-1 
DL-1 
Table 13: 
Recommended Dose Modifications of Pemetrexed, Cisplatin, and 
Carboplatin Chemotherapy Agents for Nonhematological Toxicity 
Event 
CTCAE Grade 
Pemetrexed 
Cisplatin 
Carboplatin 
Dose level from Table 11 
Nausea or vomiting 
Grade 3 or 4 
DL0 
DL0 
DL0 
Diarrhea 
Grade 3 or 4 
DL-1 
DL-1 
DL0 
Mucositis 
Grade 3 or 4 
DL-2 
DL0 
DL0 
Neurotoxicity 
Grade 2 
DL0 
DL-2 
DL0 
Grade 3 or 4 
Discontinue 
Discontinue 
DL-1 
Transaminase elevation 
Grade 3 
DL-1 
DL-1 
DL-1 
Grade 4 
Discontinue 
Discontinue 
Discontinue 
Other nonhematological 
toxicity 
Grade 3 or 4 
DL-1 
DL-1 
DL-1 
If nab-paclitaxel is offered to eligible participants, the following is recommended.  Participants 
should be administered nab-paclitaxel on Day 1 of a cycle with an ANC ≥ 1500 cells/mm3 and a 
platelet count of ≥ 100,000 cells/mm3.  In participants who develop severe neutropenia or 
thrombocytopenia, withhold treatment until counts recover to an ANC of ≥ 1500 cells/mm3 and a 
platelet count of ≥ 100,000 cells/mm3 on Day 1.  For each subsequent weekly dose, withhold 
treatment until counts recover to an ANC of ≥ 500 cells/mm3 and a platelet count of 
≥ 50,000 cells/mm3 on Days 8 or 15 of the cycle or the dose is to be withheld until counts 
recover. 
Upon restarting dosing, permanently reduce nab-paclitaxel and carboplatin doses as shown in 
Table 14. 

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Table 14: 
Dose Reductions for Hematologic Adverse Drug Reactions for Nab-Paclitaxel 
Adverse Drug Reaction 
Occurrence 
Weekly 
Nab-Paclitaxel 
Dose (mg/m2)a 
Every 3 Week 
Carboplatin Dose 
(AUC mg/mL × min)a 
Neutropenic Fever (ANC < 500/mm3 
with fever > 38°C) 
OR 
Delay of next cycle by more than 7 days 
for ANC < 1500/mm3 
OR 
ANC < 500/mm3 for more than 7 days 
First 
75 
4.5 
Second 
50 
3 
Third 
Discontinue 
Platelet count < 50,000/mm3 
First 
75 
4.5 
Second 
Discontinue 
a On Day 1 of the 21-day cycle reduce the dose of nab-paclitaxel and carboplatin simultaneously.  On Days 8 or 15 
of the 21-day cycle reduce the dose of nab-paclitaxel; reduce the dose of carboplatin in the subsequent cycle. 
For Grade 2 or 3 cutaneous toxicity, Grade 3 diarrhea, or Grade 3 mucositis, interrupt treatment 
until the toxicity improves to ≤ Grade 1, then restart treatment according to the guidelines in 
Table 15.  For ≥ Grade 3 peripheral neuropathy, withhold treatment until resolution to ≤ Grade 1.  
Treatment may be resumed at the next lower dose level in subsequent cycles according to the 
guidelines in Table 15.  For any other Grade 3 or 4 nonhematologic toxicity, interrupt treatment 
until the toxicity improves to ≤ Grade 2, then restart treatment according to the guidelines in 
Table 15. 
Table 15: 
Dose Reductions for Nonhematologic Toxicities for Nab-Paclitaxel 
Nonhematologic Toxicity 
Occurrence 
Weekly 
Nab-Paclitaxel 
Dose (mg/m2)a 
Every 3 Week 
Carboplatin Dose 
(AUC mg/mL × min)a 
Grade 2 or 3 cutaneous toxicity 
Grade 3 diarrhea 
Grade 3 mucositis 
≥ Grade 3 peripheral neuropathy 
Any other Grade 3 or 4 nonhematologic toxicity 
First 
75 
4.5 
Second 
50 
3.0 
Third 
Discontinue 
Grade 4 cutaneous toxicity, diarrhea, or mucositis 
First 
Discontinue 
a On Day 1 of the 21-day cycle reduce the dose of nab-paclitaxel and carboplatin simultaneously.  On Days 8 or 15 
of the 21-day cycle reduce the dose of nab-paclitaxel; reduce the dose of carboplatin in the subsequent cycle. 
Toxicity may be attributed to individual chemotherapy agents or INCMGA00012 alone or in 
combination.  Dose modification must be based on maximum toxicity experienced during a 
cycle.  If a dose reduction for toxicity occurs with any chemotherapy agent, the dose may not be 
re-escalated.  
Participants can have a maximum of 2 dose modifications to each of the components of study 
treatment throughout the course of the study for toxicities.  If a participant experiences several 
toxicities and there are conflicting recommendations, the most conservative dose adjustment 

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recommended should be followed (dose reduction appropriate to the most severe toxicity).  
Participants who require a third dose modification to any particular component will have that 
agent discontinued. 
Reduction of 1 chemotherapy agent and not the other agent is appropriate if, in the opinion of the 
investigator, the toxicity is clearly related to 1 of the treatments.  If, in the opinion of the 
investigator, the toxicity is related to the combination of 2 chemotherapy agents, both drugs 
should be reduced according to recommended dose modifications.  If the toxicity is related to the 
combination of 3 agents, all 3 study treatment agents should be reduced (if applicable), 
interrupted, or discontinued according to the recommend dose modifications.  
Participants may have chemotherapy discontinued and continue on INCMGA00012/placebo 
alone.  Similarly, participants may discontinue INCMGA00012/placebo and continue on 
chemotherapy alone during the first 4 cycles if appropriate.  
Chemotherapy may be interrupted for a maximum of 6 weeks; INCMGA00012/placebo may be 
interrupted for a maximum of 12 weeks as mentioned above. 
These recommendations are a guide and do not replace investigator's judgment when applicable 
local label recommendations are not fully described, or when there are immediate local label 
updates available. 
All dose modifications should be based on the AE requiring the greatest dose modification. 
6.5.2.2. 
Modifications Due to Creatinine Clearance 
Creatinine clearance will be based on the original weight-based Cockcroft and Gault formula 
(see Appendix C), or as per institutional method guideline, or based on GFR if that was used 
originally to determine eligibility (see Table 7).  Creatinine clearance must be ≥ 45 mL/minute 
before the administration of subsequent chemotherapy.  Pemetrexed and/or platinum-based 
chemotherapy may be delayed for up to 42 days to allow the participant time to recover from the 
toxicity.  If a participant's CrCl value has not returned to ≥ 45 mL/minute within 42 days after 
the previous dose, platinum and/or pemetrexed must be discontinued. 
6.5.3. 
Criteria for Permanent Discontinuation of Study Drug 
The occurrence of unacceptable toxicity not caused by the underlying disease will require that 
the study drug (ie, INCMGA00012/placebo) be permanently discontinued.  Unacceptable 
toxicity is defined as follows: 
• Occurrence of an AE that is related to study drug that, in the judgment of the 
investigator or the sponsor's medical monitor, compromises the participant's ability to 
continue study-specific procedures or is considered to not be in the participant's best 
interest. 
• An irAE that has not resolved within 12 weeks from the last infusion. 
• Any AE defined in the dose modification guidelines requiring that study drug be 
discontinued. 
See Section 7 for discontinuation procedures.  See Section 6.5 for study drug and study treatment 
discontinuation/modifications. 

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6.6. 
Concomitant Medications and Procedures 
All concomitant medications and treatments (including over-the-counter or prescription 
medicines, vitamins, vaccines, herbal supplements, prophylaxis for chemotherapy, and/or rescue 
medications for toxicities) must be recorded in the eCRF.  Also the following will be recorded 
during the study: 
• any prior medication received up to 28 days before the first dose of study treatment 
through the safety follow-up visit or until the participant begins a new anticancer 
therapy, whichever occurs first. 
• any addition, deletion, or change in the dose of these medications. 
• any treatments/procedures that are required to manage a participant's medical 
condition. 
• concomitant medications administered after 30 days after the last dose of study 
treatment should be recorded for SAEs as defined in Section 9.2. 
The medical monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
6.6.1. 
Permitted Medications and Procedures 
For full details of prophylaxis medication recommendations for chemotherapy agents refer to 
approved drug product labels and updates. 
Permitted medications and procedures include the following:  
• Before administration of INCMGA00012/placebo, premedication with 
acetaminophen/paracetamol and a histamine blocker should be considered for 
participants who have had previous systemic reactions to protein product infusions or 
when recommended by institutional policy as described in Section 6.5.1.1. 
• Premedications before administration of chemotherapy agents should be given in 
accordance with prescribing information and standard practice. 
− Examples include leucovorin for pemetrexed-related toxicity for treatment of 
CTCAE Grade 4 leukopenia or Grade 4 neutropenia lasting more than 3 days, 
beginning on the third day of Grade 4 myelosuppression; or immediately for 
treatment of Grade 4 thrombocytopenia, bleeding associated with Grade 3 
thrombocytopenia, or Grade 3 or 4 mucositis. 
• Anemia:  Transfusions and/or erythropoietin may be utilized as clinically indicated 
for the treatment of anemia, and the information will be collected.  Consider a 
potential immunologic etiology.  
• Thrombocytopenia:  Transfusion of platelets may be used if clinically indicated and 
the information will be collected.  Immune thrombocytopenia should be ruled out 
before initiation of platelet transfusion. 

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• The use of corticosteroids is permitted in the following situations: 
− Acute treatment for an AE. 
− Physiologic corticosteroid replacement therapy at doses ≤ 10 mg/day of 
prednisone or equivalent for adrenal or pituitary insufficiency and in the absence 
of autoimmune disease. 
− Participants with asthma who require intermittent use of bronchodilators, inhaled 
steroids, or local steroid injections. 
− Topical, ocular, intra-articular, or intranasal steroids (with minimal systemic 
absorption) 
− Brief course of corticosteroids for prophylaxis (eg, < 3 weeks for contrast dye 
allergy), study-treatment related premedication as described above, chronic 
obstructive pulmonary disease exacerbation, or for treatment of nonautoimmune 
conditions (eg, delayed-type hypersensitivity reaction cause by a contact 
allergen). 
• Palliative and supportive care is permitted during the course of the study for 
underlying medical conditions and management of symptoms. 
• The high intraindividual variability of the coagulation status during disease and the 
possibility of interaction between oral anticoagulants and anticancer chemotherapy 
require increased frequency of INR monitoring, if it is decided to treat the participant 
with oral anticoagulants. 
• SARS-CoV-2 vaccines (or vaccines for other viral diseases).  See note regarding live 
vaccines in Section 6.6.3. 
• Applicable ancillary procedures and tests (eg, SARS-CoV-2 RT-PCR test, chest 
X-ray, or chest CT scan) to fully diagnose, monitor, and treat COVID-19. 
6.6.2. 
Restricted Medications and Procedures 
When needed, ASCO guideline updates on the use of hematopoietic colony-stimulating factors 
should be followed for participants (Smith et al 2015).  Consider a potential immunologic 
etiology. 
For participants receiving pemetrexed, the following concomitant use should be taken into 
consideration: 
• As per the approved pemetrexed label, participants taking NSAIDs or salicylates with 
mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/minute) 
will not take the NSAID or salicylate (other than an aspirin dose ≤ 1.3 grams per day) 
for 2 days before, the day of, and 2 days after receiving premetrexed.  Participants 
taking NSAIDs or salicylates with a long half-life (eg, naproxen, piroxicam, 
diflunisal, nabumetone) will not take the NSAIDs or salicylates for 5 days before, the 
day of, and 2 days after premetrexed. 

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For participants receiving carboplatin, the following concomitant use should be taken into 
consideration: 
• Cyclosporine (and by extrapolation tacrolimus and sirolimus):  excessive 
immunosuppression with risk of lymphoproliferation. 
• Concurrent therapy with nephrotoxic drugs or ototoxic drugs such as 
aminoglycosides, vancomycin, capreomycin, and diuretics may increase or 
exacerbate toxicity due to carboplatin induced changes in renal clearance. 
• Aminoglycosides:  the concomitant use of carboplatin with aminoglycosides 
antibiotics should be approached with caution due to the cumulative nephrotoxicity 
and ototoxicity. 
• Loop diuretics:  the concomitant use of carboplatin with loop diuretic should be 
approached with caution due to the cumulative nephrotoxicity and ototoxicity. 
• Phenytoin, fosphenytoin:  risk of exacerbation of convulsions (resulting from the 
decrease of phenytoin digestive absorption by the cytotoxic drug) or risk of toxicity 
enhancement or loss of efficacy of the cytotoxic drug (due to increased hepatic 
metabolism by phenytoin).  Thus, concomitant use is usually not recommended. 
For participants receiving cisplatin, the following concomitant use should be taken into 
consideration: 
• Phenytoin, fosphenytoin:  risk of exacerbation of convulsions (resulting from the 
decrease of phenytoin digestive absorption by the cytotoxic drug) or risk of toxicity 
enhancement or loss of efficacy of the cytotoxic drug (due to increased hepatic 
metabolism by phenytoin).  Plasma levels of anticonvulsant agents should be checked 
as warranted, as they may become subtherapeutic during cisplatin therapy. 
• Aminoglycoside antibiotics when used concurrently with cisplatin can cause 
nephrotoxicity and thus they are not recommended for use. 
For participants receiving nab-paclitaxel or paclitaxel, use caution when concomitantly 
administering nab-paclitaxel with inhibitors of either CYP2C8 or CYP3A4 (eg, ketoconazole and 
other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, clopidogrel, cimetidine, 
ritonavir, saquinavir, indinavir, nelfinavir) because toxicity of nab-paclitaxel/paclitaxel may be 
increased due to higher paclitaxel exposure. 
For additional use of any restricted medications or for concomitant medications that must be 
used only in rare medical situations concurrently with the chemotherapy agents used in this 
study, or for any updates, refer to the local package inserts or prescribing information. 
6.6.3. 
Prohibited Medications and Procedures 
Medications or vaccinations specifically prohibited in the exclusion criteria (see Section 5.2) are 
not allowed during the study.  If there is a clinical indication for one of these medications or 
vaccinations specifically prohibited during the study, discontinuation from study treatment may 
be required.  The medical monitor should be consulted. 

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Participants are prohibited from receiving the following therapies during the screening and 
treatment period of this study: 
• Antineoplastic systemic chemotherapy or biological therapy not specified in this 
Protocol. 
• Immunotherapy not specified in this Protocol. 
• Investigational agents other than INCMGA00012. 
• Radiation therapy. 
− Surgery or radiotherapy for tumor control is not permitted during the study 
• Live vaccines within 30 days before the first dose of study treatment, while 
participating in the study, and until 90 days after last dose of study drug.  Examples of 
live vaccines include, but are not limited to, the following:  measles, mumps, rubella, 
varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine.  Seasonal influenza 
vaccines for injection are generally killed virus vaccines and are allowed; however, 
intranasal influenza vaccines are live attenuated vaccines and are not allowed. 
• The use of probiotic dietary supplements. 
Participants who, in the assessment by the investigator, require the use of any of the 
aforementioned treatments for clinical management should be removed from the study.  
Participants may receive other medications that the investigator deems to be medically 
necessary. 
6.7. 
Crossover Study Drug Treatment and Criteria 
Participants who experience documented PD by RECIST v1.1 verified by the BICR and who 
were randomized to placebo and chemotherapy will have the opportunity to receive 
INCMGA00012 open-label monotherapy in the crossover period.  These participants with 
verified PD will have treatment assignment unblinded (system-based through IRT only after 
sponsor-granted clinical approval of the request made for crossover) and be able to receive 
INCMGA00012 monotherapy for up to 35 cycles or approximately 2 years. 
Medical emergency unblinding procedures should not be used for the purposes of determining 
eligibility for crossover.  Refer to the IRT Manual for details on how to make a crossover 
request. 
Crossover is optional and is at the discretion of the investigator (with the sponsor's agreement).  
Participants who meet the following criteria are eligible for crossover: 
• Documentation of PD will be defined as BICR assessment. 
• Adverse events (except alopecia and peripheral neuropathy) due to therapy must have 
improved to CTCAE v5.0 ≤ Grade 1. 
• If a participant is unstable as a result of a new or progressing brain metastasis(es), the 
participant will not be eligible for crossover. 
• Participant must have an ECOG performance status of 0 to 1. 

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• Participant has not received any other systemic anticancer therapies other than the 
chemotherapy administered during the study treatment period. 
• If required, the participant must have completed palliative radiotherapy (30 Gy or 
less) ≥ 7 days before the first dose of crossover study drug. 
• Participant has adequate organ function as indicated by the laboratory values in 
Table 7. 
For imaging required and the SoA in the crossover period, see Section 8.3.5 and Table 5, 
respectively. For the follow-up survival period, see Section 8.12.3. 
6.8. 
Treatment After the End of the Study 
Participants may receive approximately 2 years (or up to 35 cycles) of treatment with 
INCMGA00012/placebo.  Participants receiving treatment with pemetrexed may continue to 
receive pemetrexed beyond 2 years as per approved product label if believed appropriate by the 
investigator (it may occur off-study after primary analysis is performed). 

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7. 
DISCONTINUATION OF STUDY TREATMENT AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Treatment 
7.1.1. 
Reasons for Discontinuation 
In this study, a participant may discontinue from treatment but continue to participate in the 
Protocol-scheduled activities, as long as the participant does not withdraw consent.  The 
discontinuation from the study treatment is permanent. 
Participants must be discontinued from study treatment for the following reasons: 
• Consent is withdrawn. 
Note:  Consent withdrawn means that the participant has explicitly indicated that they 
do not want to be followed any longer; in this case, no further data, except data in 
public domain, may be solicited from or collected on the participant.  Participants 
may choose to discontinue study treatment and remain in the study to be followed for 
progression and survival. 
• Lost to follow-up. 
Note:  As OS is a primary objective, documented multiple (ie, at least 2) efforts must 
be made to avoid lost to follow up. 
• Further participation would be injurious to the participant's health or well-being, in 
the investigator's medical judgment. 
• Unacceptable toxicity as noted in Section 6.5. 
• Intercurrent illness that prevents further administration of treatment. 
• Completed 35 cycles of INCMGA00012/placebo. 
Note:  The number of cycles is calculated starting with the first dose.  
• Verified radiologic disease progression. 
Note:  If a participant has progression of disease verified by central radiological 
review using RECIST v1.1, a request may take place to move to the crossover period 
(through a system-based IRT-only process after sponsor-granted clinical approval of 
the request made for crossover as per Section 6.7).  If a participant was receiving 
placebo and meets all crossover criteria defined in Section 6.7, they will have the 
opportunity to cross over to receive open-label INCMGA00012 monotherapy.  Refer 
to the IRT Manual for details on how to make a crossover request. 
• Any progression or recurrence of any malignancy, or any occurrence of another 
malignancy that requires other anticancer treatment. 
• Intercurrent illness other than another malignancy as noted above that prevents 
further administration of study treatment. 
• A confirmed positive serum pregnancy test. 

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• Investigator's decision to withdraw the participant from study treatment. 
• The study is terminated by the sponsor or due to negative results so experimental 
study treatment may not be administered. 
• The study is terminated by the local health authority, IRB, or IEC. 
A participant may be discontinued from study treatment as follows: 
• If, during the course of the study, a participant is found not to have met eligibility 
criteria, the medical monitor, in collaboration with the investigator, will determine 
whether the participant should be withdrawn from study treatment. 
• If a participant is noncompliant with study procedures or study drug/treatment 
administration in the investigator's opinion, the sponsor should be consulted for 
instruction on handling the participant. 
Chemotherapy may be discontinued when a participant has received the maximum number of 
cycles permitted by the local regulatory authority/local label. 
7.1.2. 
Discontinuation Procedures 
In the event that the decision is made to permanently discontinue the study treatment, each 
participant will be followed for 90 days for AE monitoring following cessation of study 
treatment, or 30 days following cessation of treatment if new anticancer therapy is initiated as 
described in Section 9.  Serious AEs will be collected for up to 90 days following cessation of 
study treatment, or 30 days following cessation of treatment if the participant initiates new 
anticancer therapy, whichever is earlier.  Participants will have post-treatment follow-up for 
disease status until disease progression, initiating a nonstudy cancer treatment, withdrawing 
consent, or becoming lost to follow-up.  After documented disease progression, each participant 
will be followed for OS until death or withdrawal of consent.  These visits are described in 
Table 3 through Table 5, as applicable. 
The last date of the last dose of study drug/treatment and the reason for discontinuation of study 
treatment will be recorded in the eCRF. 
If a participant is discontinued from study treatment: 
• The reason(s) for discontinuation must be documented in the participant's medical 
record and the primary reason for discontinuation must be included in the eCRF. 
• The EOT visit should be performed. 
• The status of the participant should be updated in IRT. 
• Participants must be followed for safety until the time of the follow-up visit or until 
study drug/treatment–related toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longest. 
• Participants will enter the survival follow-up period.  See Section 8.12.3 for full 
survival follow-up requirements. 
If the participant discontinues study treatment and actively withdraws consent for collection of 
follow-up data (safety follow-up or disease assessment), then no additional data collection 

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should occur; however, participants will have the option of withdrawing consent for study 
treatment but continuing in the follow-up period of the study for safety/efficacy assessments 
(eg, survival follow-up). 
7.2. 
Participant Withdrawal From the Study 
A participant may withdraw from the study at any time at his/her own request, or may be 
withdrawn at any time at the discretion of the investigator for safety, behavioral, compliance, or 
administrative reasons. 
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. 
If a participant withdraws from the study, he/she may request destruction of any samples taken 
and not tested, and the investigator must document this in the site study records. 
See Table 3 through Table 5 for data to be collected at the time of study discontinuation and 
follow-up and for any further evaluations that need to be completed. 
7.3. 
Lost to Follow-Up 
A participant will be considered lost to follow-up if he/she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. 
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit: 
• The site must attempt to contact the participant and reschedule the missed visit as 
soon as possible and counsel the participant on the importance of maintaining the 
assigned visit schedule and ascertain whether or not the participant wishes to and/or 
should continue in the study. 
• Before a participant is deemed lost to follow-up, the investigator or designee must 
make multiple (ie, at least 2) efforts to regain contact with the participant.  These 
contact attempts should be documented in the participant's medical record. 
• Should the participant continue to be unreachable, he/she will be considered to have 
withdrawn from the study. 

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8. 
STUDY ASSESSMENTS AND PROCEDURES 
8.1. 
Administrative and General Procedures 
8.1.1. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant or his/her legally authorized representative and answer all questions 
regarding the study. 
− Informed consent must be obtained before any study-related procedures are 
conducted, unless otherwise specified by the Protocol. 
− Informed consent must be obtained using the IRB/IEC-approved version in a 
language that is native and understandable to the participant.  A template will be 
provided by the sponsor or its designee.  The sponsor or its designee must review 
and acknowledge the site-specific changes to the ICF template.  The ICF must 
include a statement that the sponsor or its designee and regulatory authorities have 
direct access to participant records. 
− The ICF must contain all required elements and describe the nature, scope, and 
possible consequences of the study in a form understandable to the study 
participant. 
• Participants must be informed that their participation is voluntary.  Participants or 
their legally authorized representative will be required to sign a statement of informed 
consent that meets the applicable requirements and regulations for the countries in 
which the study is being conducted as well as the IRB/IEC or study center. 
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection laws.  The level of disclosure 
must also be explained to the participant. 
− The medical record of a potential participant may be first reviewed during the 
site's internal oncology multidisciplinary meetings, or as required by local 
regulations, in order to discuss the best treatment to be provided to a potential 
participant.  If potential participant consents, the study doctor may contact 
participant's general practitioner to collect additional medical information.  If 
participant does not want his/her referring physician to be informed, he/she must 
tell his study doctor.  
• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained.  The authorized person obtaining the informed consent must 
also sign the ICF. 

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• Participants must provide consent to the most current version of the ICF(s) during 
their participation in the study. 
• A copy of the ICF(s) must be provided to the participant or the participant's legally 
authorized representative. 
• A participant who is rescreened is not required to sign another ICF if the rescreening 
occurs within 42 days from the previous ICF signature date. 
8.1.2. 
Screening Procedures 
Screening is the interval between signing the ICF and the day the participant is randomized in the 
study (Cycle 1 Day 1).  Screening may not exceed 28 days.  A time window of up to 3 days 
exists from randomization to study treatment administration in Cycle 1 Day 1. 
Procedures conducted as part of the participant's routine clinical management (eg, blood count, 
imaging study) and obtained before signing of informed consent may be used for screening or 
baseline purposes provided the procedure meets the Protocol-defined criteria and has been 
performed in the timeframe of the study (ie, within 10 days of Cycle 1 Day 1).  Screening 
laboratory assessments must be performed within 28 days of Cycle 1 Day 1.  If chemistry and 
hematology laboratory assessments were performed more than 10 days before Cycle 1 Day 1, 
then the tests must be repeated and eligibility confirmed before study treatment administration on 
Cycle 1 Day 1. 
For potential participants with cancer and HBV infection who need cancer treatment that lowers 
the immune system such as chemotherapy, there is a risk that an inactive, or latent, infection with 
hepatitis B can become active again.  This situation could lead to serious liver problems and may 
complicate cancer treatment.  Participants with active hepatitis will be excluded.  Hepatitis B 
surface antigen, HBV-DNA, HCV antibody and HCV-RNA (or just HCV antibody if HCV-RNA 
is not the local standard of care) will be tested.  If the hepatitis testing panel is conducted per 
standard of care within 60 days before randomization, testing does not need to be repeated.  
Additional tests at screening for hepatitis may be performed if clinically indicated. 
As per Section 5.2, active HCV is defined as a positive HCV antibody result and quantitative 
HCV-RNA results greater than the lower limits of detection of the assay.  In some countries, 
however, a qualitative HCV-RNA result may be used instead of the quantitative HCV-RNA 
result.  If positive, these participants will be excluded.  Hepatitis C antibody testing is allowed 
only for screening purposes in countries where HCV-RNA is not part of standard of care.  In 
these cases, HCV antibody–positive participants will be excluded. 
Results of a test performed before the participant signs consent as part of routine clinical 
management are acceptable in lieu of a screening test if performed within the specified 
timeframe.  For participants who are randomized, information associated with eligibility 
requirements must be entered into the appropriate eCRF pages. 
Results from the screening visit evaluations will be reviewed to confirm eligibility before 
randomization or the administration of study drug/treatment.  Laboratory results must be known 
before dosing.  Tests with results that fail eligibility requirements may be repeated once during 
screening if the investigator believes the results to be in error.  For screening assessments that are 
repeated, the most recent available result before randomization will be used to determine 

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eligibility.  See Section 8.3.2 for imaging tests at screening and Section 5.4 for information 
regarding screen failures. 
8.1.3. 
Interactive Response Technology Procedure 
Each participant will be identified in the study by a participant ID number, which is a 
combination of the site ID and participant number.  Site staff should contact the IRT to obtain the 
participant ID number during screening.  Upon determining that the participant is eligible for 
randomization, the IRT will be contacted to obtain the treatment assignment.  The investigator or 
designee will select the assigned treatments that correspond to the number provided by the IRT, 
record the unique identifiers in the eCRF, and administer the treatment to the participant.  
Additionally, the IRT will be contacted at each regular study visit to update the study drug 
supply.  Additional details are provided in the IRT Manual. 
8.1.4. 
Assignment of Treatment/Randomization Number 
All eligible participants will be randomly allocated and will receive a treatment/randomization 
number via IRT.  The treatment/randomization number identifies the participant for all 
procedures occurring after treatment allocation/randomization.  Once a treatment/randomization 
number is assigned to a participant, it can never be reassigned to another participant. 
A single participant cannot be assigned more than 1 treatment/randomization number. 
8.1.5. 
Distribution of Reminder Cards 
Participants will be provided with a reminder card at each visit.  The reminder card will indicate 
the date/time of the next visit. 
All participants will be given a Participant Identification Card identifying them as participants in 
a research study.  The card will contain study site contact information (including direct telephone 
numbers) to be utilized in the event of an emergency.  The investigator or qualified designee will 
provide the participant with a Participant Identification Card immediately after the participant 
provides written informed consent.  At the time of treatment allocation/randomization, site 
personnel will add the treatment/randomization number to the Participant Identification Card. 
8.1.6. 
COVID-19 
For Protocol procedures and tests that require additional time window allowances (due to the 
COVID-19 pandemic or temporary lockdowns) from what are permitted in Table 3 through 
Table 5, refer to Appendix G. 
Prior vaccination (eg, primary dose or booster) against SARS-CoV-2 is not required to 
participate in the study (see Section 5.1), but it is highly recommended. 
Applicable ancillary procedures and/or tests to supplement diagnosis (eg, SARS-CoV-2 RT-PCR 
test, chest X-ray, or chest CT scan), monitoring, and treatment of COVID-19 are allowed.  These 
procedures and/or tests will be documented in the eCRFs as due to COVID-19 (see 
Section 6.6.1). 
Potential participants may need to be tested for COVID-19 during the study screening period 
and/or during the study as per local requirements or health authority requirements.  Participants 
with a positive SARS-CoV-2 test during screening are ineligible to be randomized until 

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normalization of a test is obtained and clinical recovery from the infection is observed as per 
investigator's evaluation (see Section 5.2).  During the study, if participants are suspected of 
COVID-19 and test positive, they should recover and be retested before continuing with study 
treatment.  If the SARS-COV-2 test is negative, those participants can continue to be 
administered study treatment.  In addition, investigators in some countries may be obliged to 
report SARS-CoV-2–positive test results directly to the responsible health authority according to 
the local regulations at any time during the study.  Investigators are required to check health 
authority and/or local requirements for any possible specific obligations. 
8.1.7. 
Demography and Medical History 
8.1.7.1. 
Demographics and General Medical History 
Demographic data and general medical history will be collected at screening by the investigator 
or qualified designee and will include age, race, ethnicity, medical and surgical history, and 
current illnesses.  Medical history will include relevant medical or surgical treatment within the 
last 10 years that are considered to be clinically significant by the investigator. 
8.1.7.2. 
Disease Characteristics and Treatment History 
A disease-targeted medical and treatment history will be collected at screening.  Details 
regarding the participant's malignancy under study, including date of diagnosis, initial and 
current cancer stage, tumor histology, and relevant disease characteristics, and prior treatments, 
including systemic treatments, radiation, and surgical procedures, will be recorded.  A complete 
history of the participant's treatment of NSCLC (if any) will be recorded separately and not listed 
as a prior medication. 
8.1.8. 
Prior and Concomitant Medications Review 
8.1.8.1. 
Prior Medications 
The investigator or qualified designee will record medication, if any, taken by the participant 
during the study through the safety follow-up visit.  In addition, new medications started during 
the crossover period through safety follow-up visit should be recorded. 
8.1.8.2. 
Concomitant Medications 
The investigator or qualified designee will review prior medication use, including any 
protocol-specified washout requirement, and record prior medication taken by the participant 
within 28 days before the first dose of study treatment.  Antibiotics use and type is to be 
collected 2 months before first study treatment. 
8.2. 
Treatment Administration 
Administration of IV study treatment (INCMGA00012/placebo and chemotherapy) will be 
witnessed by the investigator and/or study staff. 
Study treatment should begin on the day of treatment allocation/randomization or as close as 
possible to the date on which the participant is allocated/assigned but within 3 days after the date 
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8.2.1. 
Timing of Dose Administration 
Depending on the treatment arm and investigator's choice of chemotherapy, study treatments will 
generally be administered in the following order:  INCMGA00012/placebo, 
paclitaxel/nab-paclitaxel or pemetrexed, and carboplatin or cisplatin.  Details of administering 
the individual components are discussed in Section 6. 
8.3. 
Efficacy Assessments 
Objective assessment of disease status is required, using the evaluations by RECIST v1.1 
(Eisenhauer et al 2009) by the BICR and the investigator.  The investigator's assessment will be 
recorded in the eCRF. 
8.3.1. 
Tumor Imaging and Assessment of Disease 
The process for image collection and transmission to the central imaging vendor can be found in 
the Imaging Manual.  Computed tomography is the highly preferred method for tumor imaging.  
Imaging should include the chest, abdomen, and pelvis.  For the abdomen and pelvis, contrast-
enhanced MRI may be used when CT with iodinated contrast is contraindicated or when local 
practice mandates it.  The same imaging technique regarding modality, ideally the same scanner, 
and the use of contrast should be used in a participant throughout the study to optimize the 
reproducibility of the assessment of existing and new tumor burden and improve the accuracy of 
the assessment of response or progression based on imaging.  The strongly preferred modality 
for imaging the brain is MRI. 
Local site investigator/radiology assessment based on RECIST v1.1 will be used to determine 
participant eligibility.  Although RECIST v1.1 references to a maximum of 5 target lesions in 
total and 2 per organ, the sponsor allows a maximum of 10 target lesions in total and 5 per organ.  
All scheduled images for all study participants from the sites will be submitted to the central 
imaging vendor.  In addition, images (including via other modalities) that are obtained at an 
unscheduled time point to determine disease progression, and imaging obtained for other reasons 
that demonstrate radiologic progression, should also be submitted to the central imaging vendor.  
Note:  If a study participant is hospitalized due to a medical emergency during the study, the 
participant must still undergo the Protocol tumor imaging procedures as in Table 3 through 
Table 5 as soon as the participant is recovered or stable. 
The central imaging vendor will expedite the verification of PD upon request following local site 
investigator-assessed radiologic evidence of PD.  Verification of progression by BICR (not by 
investigator's assessment) is 1 of the qualification criteria for the crossover period.  Expedited 
verification of radiologic PD by the central imaging vendor will be communicated to the study 
site and sponsor.  Treatment continues in a blinded fashion until PD has been verified by BICR, 
and images continue to be submitted to the central imaging vendor.  Additionally, if the 
investigator considers the participant has progressed, but elects to implement iRECIST, the 
investigator will assess for confirmation of progression by iRECIST at subsequent timepoints.  
Images should continue to be submitted to the central imaging vendor. 

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8.3.2. 
Initial Tumor Imaging 
Initial tumor imaging at screening must be performed within 28 days before the date of 
randomization.  The site study team must review screening images to confirm the participant has 
measurable disease per RECIST v1.1.  The screening images must be submitted to the central 
imaging vendor for retrospective confirmation of eligibility. 
Scans including PET-CT scans performed as part of routine clinical management are acceptable 
for use as screening tumor imaging if they are of diagnostic quality, performed within 28 days 
before the date of randomization, and can be assessed by the central imaging vendor. 
Baseline brain imaging per the local standard of care is required if there are signs or symptoms 
suggesting that the participant has disease involvement in the CNS.  Postbaseline brain imaging 
will be performed only if the screening brain imaging was positive or as clinically indicated; if 
indicated, brain scans should occur at the same time as other disease assessment scans.  Brain 
imaging using MRI is strongly preferred.  If MRI is medically contraindicated, CT with contrast 
is an acceptable alternative. 
Participants with previously treated brain metastases may participate provided they have 
radiographically stable brain metastases, that is, without evidence of progression by imaging 
during screening, and confirmed by MRI if MRI was used at prior imaging, or confirmed by 
CT imaging if CT used at prior imaging obtained at least 4 weeks apart and show no evidence of 
intracranial progression.  Any neurologic symptoms must have returned to baseline and 
participants must have no clinical evidence of new or enlarging brain metastases, and have not 
used steroids for brain metastases for at least 3 days before study initiation as per local site 
assessment.  This exception does not include carcinomatous meningitis, as participants with 
carcinomatous meningitis are excluded regardless of clinical stability. 
8.3.3. 
Tumor Imaging During the Study 
The on-study treatment assessments should be performed every 6 weeks (42 days ± 7 days) for 
the first 24 weeks, then every 9 weeks (± 7 days) for the next 27 weeks, and subsequently every 
12 weeks (± 14 days) until PD is verified by BICR from the date of randomization.  Imaging 
timing should follow calendar days and should not be adjusted for delays in cycle starts.  
Imaging should continue to be performed until disease progression verified by central imaging 
vendor (unless site investigator elects to continue treatment and follow iRECIST), the start of 
new anticancer treatment, withdrawal of consent, or death, whichever occurs first.  All 
supplemental imaging must be submitted to the central imaging vendor.  If the investigator elects 
to continue treatment and follow iRECIST after initial radiographic PD, imaging should continue 
after the participant is reconsented, and images should be submitted to the central imaging 
vendor. 
Participants who have unconfirmed disease progression may continue on treatment at the 
discretion of the site investigator until progression is confirmed by the site provided they have 
met the conditions detailed in Section 8.3.7.  Participants who have confirmed disease 
progression as assessed by the site will discontinue the treatment. 
For participants who are eligible to enter the crossover period, refer to Section 8.3.5. 

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8.3.4. 
End of Study Treatment and Follow-Up of Tumor Imaging 
In participants who discontinue study treatment, tumor imaging should be performed at the time 
of treatment discontinuation (± 4-week window).  The imaging assessment should be performed 
even if the participant has clinical symptoms of deterioration or clinical progression in order to 
avoid censoring events.  If a previous scan was obtained within 4 weeks before the date of 
discontinuation, then a scan at treatment discontinuation is not mandatory.  In participants who 
discontinue study treatment due to documented disease progression, this is the final required 
tumor imaging. 
Once a participant stops imaging assessments (eg, PD or starting a new anticancer therapy) the 
participant moves into the survival follow up period. 
In participants who discontinue study treatment without documented disease progression, tumor 
imaging using the same imaging schedule used while on treatment to monitor disease status until 
(1) the start of new anticancer treatment, (2) disease progression, (3) death, or (4) the end of the 
study, whichever occurs first, should be used.  The timing of follow-up visits should be 
scheduled to coincide with the participant's follow-up imaging.  Once imaging is complete 
(eg, BICR-verified PD, new antineoplastic therapy), the participant enters into survival 
follow-up. 
If a participant receives subsequent or new anticancer therapy after documentation of PD on or 
after study treatment, the imaging schedule should follow the recommendation in 
Section 8.12.3.1. 
8.3.5. 
Crossover Tumor Imaging 
A scan must be performed within 4 weeks before starting treatment with the first cycle of 
INCMGA00012 monotherapy in this period. 
Then, the first on-study imaging assessment should be performed at 12 weeks (84 days ± 14 days) 
from the start of INCMGA00012 study drug treatment or more frequently if clinically indicated.  
Per RECIST v1.1, partial or complete response should be confirmed by a repeat tumor imaging 
assessment not less than 4 weeks from the date the response was first documented. 
The tumor imaging for confirmation of response may be performed at the earliest 4 weeks after 
the first indication of response, or at the next scheduled scan, whichever is clinically indicated.  
Participants will then return to regular scheduled imaging every 12 weeks (84 days ± 14 days), 
starting with the next scheduled imaging timepoint.  Participants who obtain a confirmation scan 
do not need to undergo scheduled tumor imaging if it is < 4 weeks later and may wait until the 
next scheduled imaging timepoint. 
Imaging should continue to be performed until second PD, the start of new anticancer treatment, 
withdrawal of consent, death, or notification by the sponsor, whichever occurs first. 
In participants who discontinue study treatment, tumor imaging should be performed at the time 
of treatment discontinuation (± 4-week window).  If a previous scan was obtained within 
4 weeks prior to the date of discontinuation, then a scan at treatment discontinuation is not 
mandatory.  In participants who discontinue study treatment due to documented disease 
progression, this is the final required tumor imaging. 

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In participants who discontinue study treatment without documented disease progression, every 
effort should be made to continue monitoring their disease status by radiologic imaging every 
12 weeks until (1) the start of new anticancer treatment, (2) disease progression, (3) death, or 
(4) the end of the study, whichever occurs first. 
8.3.6. 
RECIST Version 1.1 Assessment of Disease 
RECIST v1.1 will be applied by the central imaging vendor as the primary measure for 
assessment of tumor response, date of PD, and as a basis for all Protocol guidelines related to 
disease status (eg, discontinuation of study therapy).  Initial tumor imaging showing site-assessed 
PD should be submitted to the central imaging vendor immediately for confirmation regardless if 
the investigator intends to cross over without hesitation to INCMGA00012 monotherapy.  The 
site will be notified if the central imaging vendor verifies PD using RECIST v1.1. 
8.3.7. 
iRECIST Assessment of Disease 
Immunotherapeutic agents may produce antitumor effects by potentiating endogenous 
cancer-specific immune responses.  The response patterns seen with such an approach may 
extend beyond the typical time course of responses seen with cytotoxic agents and can manifest 
as a clinical response after an initial increase in tumor burden or the appearance of new lesions.  
iRECIST is not an exploratory objective.  The investigator may use iRECIST to make treatment 
decisions after PD is verified by BICR by RECIST v1.1 for assessing tumor response and 
progression if participants consent and are clinically stable (Seymour et al 2017). 
These disease assessments for clinically stable participants will be performed by the study site, 
and participants will need to have an opportunity to be reconsented.  Participants may receive 
study treatment pending confirmation of PD if they are clinically stable as defined by the 
following criteria: 
• Absence of clinically significant signs and symptoms (including worsening of 
laboratory values) indicating disease progression.  
• No decline in ECOG performance status. 
• No requirement for intensified management of disease-related symptoms. 
• Absence of rapid progression of disease.  
• Absence of progressive tumor at critical anatomical sites (eg, spinal cord 
compression) requiring urgent alternative medical intervention. 
If radiologic imaging shows iUPD, tumor assessment should be repeated ≥ 4 weeks later (but no 
later than 8 weeks) to confirm iCPD with the option of continuing treatment while awaiting 
radiologic confirmation of progression.  Details of iRECIST categories and implementation are 
in Appendix F. 
8.4. 
Health Economics 
Not applicable. 

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8.5. 
Health Care Resource Utilization 
Not applicable. 
8.7. 
Safety Assessments 
See Section 6.5 for guidelines regarding the management of relevant laboratory or other safety 
assessment abnormalities. 
8.7.1. 
Adverse Events 
Adverse events will be monitored from the time the participant signs the ICF until at least 
90 days after the last dose of study drug/treatment, or 30 days following cessation of study 
drug/treatment if new anticancer therapy is initiated.  Serious adverse events will be collected for 
up to 90 days following cessation of study drug/treatment, or 30 days following cessation of 
drug/treatment if the participant initiates new anticancer therapy.  Refer to Section 9.4 for 
Reporting of Serious Adverse Events. 
Adverse events that begin or worsen after informed consent should be recorded on the Adverse 
Events Form in the eCRF regardless of the assumption of a causal relationship with the study 
treatments.  Conditions that were already present at the time of informed consent should be 
recorded on the Medical History Form in the eCRF.  Adverse events (including laboratory 

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abnormalities that constitute AEs) should be described using a diagnosis whenever possible 
rather than by individual underlying signs and symptoms. 
Adverse events will be reported by the participant (or, when appropriate, by a caregiver, 
surrogate, or the participant's legally authorized representative).  The investigator and any 
qualified designees are responsible for detecting, documenting, and recording events that meet 
the definition of an AE or SAE and remain responsible for following-up on AEs that are serious, 
considered related to the study treatment/procedures, or that caused the participant to discontinue 
the study treatment.  Care will be taken not to introduce bias when detecting AEs and/or SAEs.  
Open-ended and nonleading verbal questioning of the participant, such as "How are you 
feeling?" is the preferred method to inquire about AE occurrences.  Adverse events may also be 
detected when they are volunteered by the participant during the screening process or between 
visits, or through physical examinations, laboratory tests, or other assessments.  The definition, 
reporting, and recording requirements for AEs are described in Section 9. 
All SAEs will be recorded and reported to the sponsor or designee within 24 hours.  The 
investigator will submit any updated SAE data to the sponsor within 24 hours of it being 
available. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
The severity of AEs will be determined per CTCAE v5.0. 
8.7.2. 
Physical Examinations 
At the screening and safety follow-up visits, a comprehensive physical examination should be 
conducted.  The comprehensive physical examination will include height (at screening or before 
dose administration on Cycle 1 only) and body weight and assessment(s) of the following organ 
or body systems:  skin; head, eyes, ears, nose, and throat; thyroid; lungs; cardiovascular system; 
abdomen (liver, spleen); extremities; and lymph nodes; as well as a brief neurological 
examination.  For chemotherapy agents, additional testing may be necessary.  For example, since 
ototoxicity of cisplatin is cumulative, audiometric testing may be performed prior to initiating 
therapy and prior to each subsequent dose of drug.  Refer to approved product label information 
for each chemotherapy agent used as part of study treatment and perform additional tests as 
clinically indicated and as recommended in the approved labels. 
During the study, targeted examination as indicated in Table 3 through Table 5 will be conducted 
unless otherwise clinically indicated.  Participants will be assessed by the investigator or 
medically qualified designee per institutional standard of care.  These assessments should be an 
evaluation as indicated by participant symptoms, AEs, or other findings and documented on the 
AE eCRF.  Abnormalities identified after the first dose of study treatment constitute an AE if 
they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in study treatment. 

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8.7.3. 
Vital Signs 
Vital sign measurements include blood pressure, pulse, respiratory rate (where it is part of 
standard of care), and body temperature and are to be taken as specified in Table 3 through 
Table 5.  Blood pressure and pulse will be taken preferably with the participant in the recumbent, 
semirecumbent, or sitting position after 5 minutes of rest. 
Abnormal vital sign results identified after the first dose of study treatment constitute an AE if 
they are considered clinically meaningful, induce clinical signs or symptoms, require 
concomitant therapy, or require changes in study treatment. 
8.7.4. 
Electrocardiograms 
Baseline ECGs (local) will be obtained at screening, with additional ECGs obtained at the safety 
follow-up visit, and as clinically indicated for all participants (see Table 3 and Table 4).  Single 
12-lead ECGs will be obtained locally using an ECG machine that automatically calculates the 
heart rate and measures PR, QRS, QT, and QTc intervals.  All 12-lead ECGs will be performed 
with the participant in a recumbent or semirecumbent position after 5 minutes of rest.  No ECGs 
are required in the crossover period (see Table 5) unless clinically indicated. 
Additional 12-lead ECGs may be performed as clinically indicated to manage participant safety.  
The decision to include or withdraw a participant from the study based on an ECG flagged as 
"Abnormal, Clinically Significant" is the responsibility of the investigator, in consultation with 
the sponsor's medical monitor, as appropriate.  Clinically notable abnormalities that are 
considered clinically significant in the judgment of the investigator are to be reported as AEs.  
The Fridericia (preferred) or Bazett correction method for calculating QTc will be used and 
recorded in the eCRF. 
8.7.5. 
Eastern Cooperative Oncology Group Performance Status 
Eastern Cooperative Oncology Group performance status will be assessed as indicated in Table 3 
through Table 5 and according to the criteria in Appendix E. 
8.7.6. 
Laboratory Assessments 
See Appendix D for the list of clinical laboratory tests to be performed at the site (locally), and 
see Table 3 and Table 4 (during the study treatment) and Table 5 (during the crossover period) 
for the timing and frequency.  All Protocol-required laboratory assessments must be conducted in 
accordance with these SoAs. 
Additional testing may be required by the sponsor based on emerging safety data, as clinically 
indicated as per the investigator, or due to COVID-19 (see Section 8.1.6).  Laboratory results 
must be known and reviewed before dosing.  The laboratory reports must be filed with the source 
documents.  Information regarding collection, processing, and shipping of laboratory 
assessments is provided in the Laboratory Manual. 
If laboratory values from non–Protocol specified laboratory assessments performed at the 
institution's local laboratory require a change in study participant management or are considered 
clinically significant by the investigator (eg, SAE or AE or dose modification), then the results 
must be recorded in the appropriate eCRF. 

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Screening laboratory assessments must be performed within 28 days of Cycle 1 Day 1.  If 
assessments for blood chemistries and hematology are performed more than 10 days before 
Cycle 1 Day 1, then the tests must be repeated and eligibility confirmed before study treatment 
administration on Cycle 1 Day 1.  Laboratory samples collected on study Day 1 must be 
performed before study treatment administration.  After Cycle 1, predose laboratory procedures 
can be conducted up to 72 hours before study treatment administration (within the 3-day study 
window), and results should be reviewed by the investigator or qualified designee and found to 
be acceptable before a new cycle of treatment is initiated. 
Endocrine function laboratory tests are to be performed on Cycle 2 Day 1 and Cycle 4 Day 1 and 
then repeated every other cycle beginning with Cycle 6 for both nonsquamous and squamous 
participants.  For the thyroid function tests (ie, T3 or FT3, FT4, and TSH), participants may be 
dosed in subsequent cycles after Cycle 1 Day 1 while thyroid function tests are pending.   
In some regions, lipase and/or amylase laboratory results may not be immediately available for 
investigator review before study treatment.  In those situations, participants may be administered 
study treatment while the results are pending.  Investigators are required to review the results 
once available and take prompt action as appropriate (eg, following up with the participants by 
telephone in between visits if warranted). 
Participants with active tuberculosis are excluded from the study as per Section 5.2.  For 
participants who have a known history of active tuberculosis (eg, cured before study entry), 
tuberculosis testing approximately 6 months or as per standard of care in a particular country or 
region (eg, South Africa) where tuberculosis prevalence is high is recommended.  Investigators 
can also test as clinically indicated, regardless of the history before study entry, if suspected 
during the study. 
Hematology laboratory tests for Cycle 1 through Cycle 4, Days 8 and 15 apply only to 
participants receiving nab-paclitaxel. 
Clinically significant abnormal laboratory findings are those that are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for the 
participant's condition.  All laboratory tests with values considered clinically significantly 
abnormal during participation in the study or within 90 days after the last dose of study treatment 
(or until the start of new anticancer therapy) should be repeated until the values return to normal 
or baseline or are no longer considered clinically significant by the investigator or medical 
monitor. 
A certified laboratory local to the investigative site will perform all clinical laboratory 
assessments for safety (ie, blood chemistries, hematology assessments, coagulation tests, 
endocrine function, and urinalysis).  The investigative site will enter the laboratory results and 
laboratory normal ranges into the eCRF.  Additional tests may also be performed if clinically 
indicated. 
See Section 9.1 for information regarding laboratory abnormalities that should be recorded as an 
AE in the eCRF. 

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8.7.7. 
Pregnancy Testing 
See Table 3 through Table 5 for timepoints and frequency of pregnancy testing.  A serum 
pregnancy test (within 72 hours of Cycle 1 Day 1) for female participants of childbearing 
potential is required at screening and safety follow-up visits.  At EOT, the test can be from urine 
or serum.  Women of childbearing potential are defined in Appendix A.  During the study, 
including the crossover period, if a urine pregnancy test is positive, the results should be 
confirmed with a serum pregnancy test.  Pregnancy testing should be conducted before each 
cycle, and additionally as per local regulations, where applicable. 
Participants who are WOCBP are asked in the ICF before consenting to the study if they are 
willing to take appropriate precautions to avoid pregnancy after cessation of study treatment 
(through 180 days after the last dose of chemotherapeutic agents, and for at least 120 days after 
the last dose of INCMGA00012).  Permitted methods that are at least 99% effective in 
preventing pregnancy (see Appendix A) should be communicated to the participants and their 
understanding confirmed.  A WOCBP must agree to follow the contraceptive guidance in 
Appendix A during the treatment period and up to 180 days after last dose of chemotherapeutic 
agents and for at least 120 days after the last dose of INCMGA00012.  If a urine test is positive 
or not evaluable, a serum test will be required.  Participants must be excluded/discontinued from 
the study in the event of a positive test result. 
8.8. 
Pharmacokinetic 
 Assessments 
Blood PK 
 samples will be obtained from all participants to measure PK of 
INCMGA00012.  Blood samples for measurement of serum concentrations of INCMGA00012 
will be collected for participants at the timepoints specified 
in Table 3, Table 4, and Table 16. 
The actual date and time (24-hour clock time) of each sample will be recorded in the eCRF.  
Instructions for the sample preparation, storage, and shipping will be provided in the Laboratory 
Manual. 
The INCMGA00012 serum Cmax and Cmin at planned visits and times will be summarized.  
Pharmacokinetic data will also be analyzed using nonlinear mixed effects modeling.  Based on 
PK data obtained in this study as well as PK data obtained from other studies, a population PK 
analysis will be performed to characterize PK parameters and to further support proposed dosing 
regimen.  Samples will be analyzed by the sponsor or sponsor's designee. 
Pharmacokinetic data will also be used to explore the exposure-response relationships for 
INCMGA00012 antitumor activity/efficacy as well as safety in the proposed patient population, 
if feasible. 
No PK 
 samples are collected during the crossover period. 
Analyses of PK 
 will be performed after the study is unblinded and only on samples 
from participants who received INCMGA00012. 

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Table 16: 
Pharmacokinetic 
 Blood (Serum) Sample Timing 
Study Visit 
Timing of Sample for PK 
Cycle 1 Day 1 
• Predose within 60 minutes (± 5 min) 
before the start of infusion 
• Immediately after the end of 
INCMGA00012/placebo infusion 
(+ 10 min).  Sample must be collected 
before dose/infusion of other agents 
Cycle 2 Day 1 
Within 24 hours before the start of 
infusion 
Cycle 4 Day 1 
• Within 24 hours before the start of 
infusion 
• Immediately after INCMGA00012/ 
placebo infusion (+ 10 min).  Sample 
must be collected before dose/infusion 
of other agents 
Cycle 6 Day 1 
Within 24 hours before the start of 
infusion 
Cycle 8 Day 1, and every 
4 cycles thereafter 
Within 24 hours before the start of 
infusion 
EOT  
At the time of the visit 
Safety follow-up 
At the time of the visit 
 
 
 
 
 
 
 
 
 
 
 
8.9. 
 
 
 
 
 
 
 
 
 

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. 
 
 
 
 
 
 
8.9.1. 
Tumor Tissue Biopsies 
Tumor tissue will be collected during screening to conduct PD-L1 assessment centrally.  A 
formalin-fixed tumor tissue sample or a fresh tumor biopsy at screening will be used for central 
laboratory confirmation of PD-L1 status and stratification using the PD-L1 IHC 22C3 pharmDx 
(Dako) assay.  Fine-needle aspirates are not acceptable for use in this assay.  Adequate tumor 
sample must be available at the time of screening for PD-L1 assessment; results from a central 
laboratory are required before randomization and stratification. 
Fresh tumor biopsies should be taken from nontarget lesions when possible.  Participation in this 
study requires tumor tissue from locations not radiated before biopsy; formalin-fixed specimens 
after the participant has been diagnosed with metastatic disease are preferred for determination 
of PD-L1 status.  Detailed information regarding procedures on tumor tissue sampling and time 
window, and information of handling and shipping of tissue samples will be provided in the 
Laboratory Manual. 
If the investigator needs assistance to conduct testing of specific sensitizing driver mutations or 
gene rearrangement due to lack of documentation demonstrating eligibility criteria and cannot do 
the testing locally, the sponsor can arrange to have samples sent to its central laboratory. 
If there are a sufficient number of representative samples, including those after the 
Protocol-required screening/baseline testing, any remaining sample from screening will be used 
for baseline characterization of RNA expression and possible association with clinical outcomes.  
This potential testing will not apply to participants enrolled in China. 
8.10. 
Unscheduled Visits 
Unscheduled study visits may occur at any time if medically warranted, including scheduled 
cycle visits where a study treatment hold is indicated for toxicity purposes.  Any assessments 
performed at those visits should be recorded in the eCRF. 

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8.11. 
End of Treatment and/or Early Termination 
Once a participant permanently discontinues all study treatments, the EOT visit should be 
conducted.  Further, once a participant has permanently discontinued all study treatments, even if 
prematurely, or once they have received the last dose of study treatment defined per Protocol, 
have verified disease progression by BICR, or start a new anticancer therapy, they move into the 
survival follow-up period.  See Section 8.12.3 for full survival follow-up requirements.  
If the EOT visit coincides with a regular study visit, the EOT evaluations will supersede those of 
that scheduled visit, and the data should be entered in the EOT visit in the eCRF. 
All EOT assessments should be completed within 3 days of the decision to discontinue study 
treatment.  Should EOT occur ≤ 21 days after the final dose of study treatment, a separate 30-day 
safety follow-up visit is required and should be conducted according to Table 3 through Table 5.  
The participant should be encouraged to return for the safety follow-up visit.  If the EOT visit 
occurs > 21 days after the last study treatment, only a single EOT/30-day safety follow-up visit is 
required, and all unique assessments for the EOT and 30-day follow-up visit will be performed 
once. 
8.12. 
Follow-Up 
8.12.1. 
Safety Follow-Up 
The safety follow-up period starts once the participant discontinues study treatment.  
Approximately 30 days (± 7 days) after the EOT, participants are to attend a clinic visit for safety 
evaluation.  Adverse events and SAEs must be reported until 1) at least 90 days after the last 
dose of study drug/treatment, or 30 days following cessation of study drug/treatment if new 
anticancer therapy is initiated.  Serious AEs will be collected for up to 90 days after the last dose 
of study drug/treatment, or 30 days following cessation of drug/treatment if the participant 
initiates new anticancer therapy or 2) until toxicities resolve, return to baseline, or are deemed 
irreversible, whichever is longer. 
Reasonable efforts should be made to have the participant return for the follow-up visit and 
report any AEs that may occur during this period.  If the participant cannot return to the site for 
the safety follow-up visit, the participant should be contacted by telephone, or other methods of 
communication, for assessment of any AEs; this contact should be documented in source. 
If a participant is scheduled to begin a new anticancer therapy before the planned 30-day safety 
follow-up visit, the safety follow-up visit should be performed before a new anticancer therapy is 
started.  Once a new anticancer therapy has been initiated, the participant will move into the 
survival follow-up period. 

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8.12.2. 
Post-Treatment Disease Follow-Up 
Participants who discontinue study treatment for a reason other than PD will move into the 
disease status follow-up period and should be assessed every 12 weeks (± 14 days) by radiologic 
imaging to monitor disease status.  Every effort should be made to collect disease status 
information via study imaging assessments until: 
• The start of new anticancer therapy 
• PD (verified by BICR) 
• Death 
• The end of the study 
• Withdrawal of consent 
• Pregnancy 
• Lost to follow-up 
Information regarding poststudy anticancer treatment will be collected if new treatment is 
initiated. 
See Section 8.12.3.1 for subsequent PD after initiation of new anticancer therapy as applicable. 
8.12.3. 
Survival Follow-Up 
Survival is the primary objective of the study, thus multiple (ie, at least 2) documented efforts 
should be made to collect this information per the SoA until the study has been completed unless 
participants have permanently withdrawn their consent for follow-up. 
Once a participant has received the last dose of study drug/treatment, has confirmed disease 
progression, or starts a new anticancer therapy, the participant moves into the survival follow-up 
period.  The participant should be contacted by telephone, email, or visit at least every 12 weeks 
(± 14 days) to assess for survival status until death, withdrawal of consent, the end of the study, 
or the participant is lost to follow-up, whichever occurs first. 
For participants who do not intend to return to the study investigator for their ongoing care, 
follow-up should be maintained by phone contact, patient records, and public records/databases 
at intervals of no longer than 12 weeks (± 14 days).  Also, participants may be contacted for 
survival status at any time during the course of the study to support planned survival analyses. 
Participants may withdraw their consent at any time from any or all portions or periods of the 
study.  Participants who withdraw consent for treatment and/or imaging are encouraged to 
remain on the noninvasive survival follow-up portion of the study.  The procedures associated 
with this phase may be only telephone contacts to assess survival status and the current state of 
the participant's metastatic NSCLC.  The noninvasive nature and societal benefit of survival 
follow-up should be explained to the participant by the site staff, particularly when discontinuing 
treatment and imaging. 

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8.12.4. 
Survival Status Monitoring 
To ensure current and complete survival data is available at the time of database locks, updated 
survival status may be requested during the course of the study by the sponsor.  For example, 
updated survival status may be requested before but not limited to an eDMC review, interim 
and/or final analysis.  Upon sponsor notification, all participants who do not/will not have a 
scheduled study visit or study contact during the sponsor's defined time period will be contacted 
for their survival status (excluding participants who have a previously recorded death event in 
the clinical database). 
8.13. 
Crossover Period 
Eligible participants who had verified PD by BICR review (RECIST v1.1) first and who were on 
placebo plus chemotherapy arm after randomization will have the opportunity to receive 
monotherapy INCMGA00012 in this crossover period (see Section 6.7). Participants who 
permanently discontinue chemotherapy due to an AE, withdraw consent, or for any reason other 
than PD will not be eligible for crossover. Eligible crossover period participants may receive 
open label monotherapy INCMGA00012 for up to 35 cycles. 
In this crossover period, the imaging schedule is every 12 weeks (± 14 days).  Table 5 shows the 
schedule of activities to be performed in the crossover period including the entry criteria.  
Crossover period participants must not initiate treatment any earlier than 3 weeks 
(21 days ± 3 days) after their last dose of chemotherapy regardless of the time of progression.  
Screening procedures need to be completed within 28 days of verified PD by BICR (or up to 
42 days from last dose if recovering from an AE).  All procedures and assessments completed at 
the time of withdrawal from the main study (blinded period) may be used as appropriate for the 
start of the crossover period of the study. 
The tumor image used to determine PD can be used as the new baseline image for the crossover 
period if 1) the image was within 30 days before receiving the first dose of INCMGA00012 
monotherapy and 2) no study treatment was administered between the image and the first dose of 
INCMGA00012 monotherapy; otherwise, a new baseline image must be performed before 
INCMGA00012 monotherapy treatment. 

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9. 
ADVERSE EVENTS:  DEFINITIONS AND PROCEDURES FOR 
RECORDING, EVALUATING, FOLLOW-UP, AND REPORTING 
9.1. 
Definition of Adverse Event 
Adverse Event Definition 
• An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or 
not considered drug-related. 
• An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory 
finding), symptom, or disease (new or exacerbated) temporally associated with the use of study 
treatment. 
Events Meeting the Adverse Event Definition  
• Any safety assessments (eg, ECG, vital signs measurements), including those that worsen from 
baseline, considered clinically significant in the medical and scientific judgment of the investigator 
(ie, not related to progression of underlying disease). 
• Abnormal laboratory test results constitute an AE if they are considered clinically meaningful, induce 
clinical signs or symptoms, require concomitant therapy, or require changes in study drug.  
Whenever possible, a diagnosis (eg, anemia, thrombocytopenia) should be recorded in the eCRF 
rather than the abnormal lab result (eg, low hemoglobin, platelet count decreased). 
• 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 treatment administration even though they 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 treatment or a 
concomitant medication.  Overdose per se will 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. 
• "Lack of efficacy" or "failure of expected pharmacological action" per se will not be reported as an 
AE or SAE.  Such instances will be captured in the efficacy assessments.  However, the signs, 
symptoms, and/or clinical sequelae resulting from lack of efficacy will be reported as an AE or SAE 
if they fulfill the definition of an AE or SAE. 
Events NOT Meeting the Adverse Event Definition 
• Any clinically significant abnormal laboratory findings or other abnormal safety assessments that are 
associated with the underlying disease, unless judged by the investigator to be more severe than 
expected for the participant's condition. 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant's condition or 
considered to be treatment-related by the investigator. 
• Efficacy endpoints as outlined in Section 3 will not be reported as AE/SAEs, specifically, any event 
that is related to disease progression of the cancer under study.  All efforts must be made to not 
record worsening of an AE due to disease progression as an AE but rather the AE itself 
(eg, "worsening of congestive heart failure" versus "worsening of congestive heart failure due to 
disease progression") followed by the causality due to disease progression.  Unblinded aggregated 
efficacy endpoint events and safety data will be monitored to ensure the safety of the participants in 
the study.  Any suspected endpoint that upon review is not progression of the cancer under study will 
be forwarded to Incyte Pharmacovigilance as a SAE within 24 hours of determination that the event 
is not progression of the cancer under study. 

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• Medical or surgical procedure (eg, endoscopy, appendectomy):  the condition that leads to the 
procedure is the AE if it occurred after signing informed consent.  If present before entering the 
study, the condition should be captured as medical history. 
• Situations in which an untoward medical occurrence did not occur (social and/or convenience 
admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present or detected at 
the start of the study that do not worsen. 
9.2. 
Definition of Serious Adverse Event 
If an event is not an AE per definition above, then it cannot be an SAE even if serious conditions 
are met (eg, hospitalization for signs/symptoms of the disease under study, death due to 
progression of disease). 
A serious adverse event is defined as any untoward medical occurrence that, at any dose: 
a. Results in death 
b. Is life-threatening 
The term 'life-threatening' in the definition of 'serious' refers to an adverse drug experience that places 
the participant, in the opinion of the initial reporter, at immediate risk of death from the adverse 
experience as it occurred.  This does not include an adverse drug experience that, had it occurred in a 
more severe form, might have caused death. 
c. Requires inpatient hospitalization or prolongation of existing hospitalization 
In general, hospitalization signifies that the participant has been detained (usually involving at least an 
overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have 
been appropriate in the physician's office or outpatient setting.  Complications that occur during 
hospitalization are AEs.  If a complication prolongs hospitalization or fulfills any other serious criteria, 
the event is serious.  When in doubt as to whether "hospitalization" occurred or was necessary, the AE 
should be considered serious. 
Hospitalization for elective treatment of a pre-existing condition that did not worsen from baseline is 
not considered an AE. 
d. Results in persistent or significant disability/incapacity 
• The term disability means a substantial disruption of a person's ability to conduct normal life 
functions. 
• This definition is not intended to include experiences of relatively minor medical significance, such 
as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and accidental trauma 
(eg, sprained ankle), that may interfere with or prevent everyday life functions but do not constitute a 
substantial disruption. 
e. Is a congenital anomaly/birth defect 
f. Other situations (Important Medical Event) 
An event that may not result in death, be immediately life-threatening, or require hospitalization, but 
may be considered serious when, based on appropriate medical judgment, the event may jeopardize the 
participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
the above definition.  Examples of such events include new invasive or malignant cancers (excluding 
the disease under study), intensive treatment in an emergency department or at home for allergic 
bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse.  Secondary malignancies should always be considered as serious 
adverse events. 

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9.3. 
Recording and Follow-Up of Adverse Events and/or Serious Adverse 
Events 
Adverse Event and Serious Adverse Event Recording 
• An AE/SAE that begins or worsens after informed consent is signed should be recorded on the 
Adverse Event Form in the eCRF.  Conditions that were present at the time informed consent was 
given should be recorded on the Medical History Form in the eCRF. 
• When an AE/SAE occurs, it is the responsibility of the investigator to review all documentation 
(eg, hospital progress notes, laboratory reports, and diagnostics reports) related to the event. 
• The investigator (or delegate) will then record all relevant AE/SAE information in the eCRF. 
• It is not acceptable for the investigator to send photocopies of the participant's medical records in 
lieu of completing the AE eCRF page. 
• There may be instances when copies of medical records for certain cases are requested.  In this case, 
all participant identifiers, with the exception of the participant number, will be redacted on the copies 
of the medical records before submission. 
• The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, and/or 
other clinical information.  Whenever possible, the diagnosis (not the individual signs/symptoms) 
will be documented as the AE/SAE.  When a clear diagnosis cannot be identified, each sign or 
symptom should be reported as a separate AE/SAE. 
To the extent possible, each AE/SAE should be evaluated to determine: 
• The severity grade (CTCAE Grade 1 to 5).  See below for further instructions on the assessment of 
intensity. 
• Whether there is at least a reasonable possibility that the AE is related to the study treatment 
(including study drug):  suspected (yes) or not suspected (no).  See below for further instructions on 
the assessment of causality. 
• The start and end dates, unless unresolved at final follow-up. 
• The action taken with regard to study drug as a result of the AE/SAE(s) and/or reference therapy. 
• The event outcome (eg, not recovered/not resolved, recovered/resolved, recovering/resolving, 
recovered/resolved with sequelae, fatal, unknown). 
• The seriousness, as per the SAE definition provided in Section 9.2. 
• The action taken with regard to the event.  Note:  If an AE is treated with a concomitant medication 
or nondrug therapy, this action should be recorded on Adverse Event Form and the treatment should 
be specified on the appropriate eCRF (eg, Prior/Concomitant Medications, Procedures and Non-Drug 
Therapy). 

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Assessment of Intensity 
The severity of AEs will be assessed using CTCAE v5 Grades 1 through 5.  If an event is not classified 
by CTCAE, the severity of the AE will be graded according to the scale below to estimate the grade of 
severity: 
The investigator will make an assessment of intensity for each AE and SAE reported during the study 
and assign it to 1 of the following categories: 
• Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment 
not indicated. 
• Grade 2:  Moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate 
activities of daily living. 
• Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. 
• Grade 4:  Life-threatening consequences; urgent treatment indicated. 
• Grade 5:  Fatal. 
Assessment of Causality 
• The investigator is obligated to assess the relationship between study treatment and each occurrence 
of each AE/SAE.  If reference therapy is used in combination with an Incyte study drug or multiple 
Incyte study drugs are used, the relationship to each study drug/reference therapy must be assessed 
(ie, for the Incyte product[s] and for the other product[s] that is used in combination with the Incyte 
product).  If appropriate, the relationship to the combination may be assessed as well. 
• A "reasonable possibility" of a relationship conveys that there are facts, evidence, and/or arguments 
to suggest a causal relationship, rather than that a relationship cannot be ruled out. 
• The investigator will use clinical judgment to determine the relationship. 
• The investigator will also consult the RSI in the IB and/or Product Information, for marketed 
products, in his/her assessment. 
• Alternative causes, such as underlying disease(s), concomitant therapy, and other risk factors, as well 
as the temporal relationship of the event to study treatment administration, will be considered and 
investigated. 
• 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. 
• With regard to assessing causality of SAEs: 
− There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report.  However, the causality assessment is one of the criteria 
used when determining regulatory reporting requirements.  Therefore, it is very important that 
the investigator always make an assessment of causality for every event before the initial 
transmission of the SAE. 
− The investigator may change his/her opinion of causality in light of follow-up information and 
send a follow-up SAE report with the updated causality assessment. 

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Follow-Up of Adverse Events and Serious Adverse Events 
• The investigator is obligated to perform or arrange for the conduct of supplemental measurements 
and/or evaluations as medically indicated or as requested by the sponsor to elucidate the nature 
and/or causality of the AE or SAE as fully as possible.  This may include additional laboratory tests 
or investigations, histopathological examinations, or consultation with other health care 
professionals.  Examples of AEs that require follow-up with other health care professionals, 
consultation and periodic follow-up, or additional diagnostic tests are TEN, SJS, and myocarditis. 
• New or updated information will be recorded in the originally completed eCRF. 
• Any updated SAE data will be submitted to the sponsor (or designee) within 24 hours of receipt of 
the information. 
• Once an AE is detected, it should be followed until it has resolved or until it is judged to be 
permanent; assessment should be made at each visit (or more frequently if necessary) of any changes 
in severity, the suspected relationship to the study drug, the interventions required to treat the event, 
and the outcome. 
• When the severity of an AE changes over time for a reporting period (eg, between visits), each 
change in severity will be reported as a separate AE until the event resolves. 
9.4. 
Reporting of Serious Adverse Events 
Regardless of suspected causality (eg, relationship to study treatment or study procedures), all 
SAEs occurring after the participant has signed the ICF through 90 days after the last dose of 
study treatment or until 30 days following cessation of study drug/treatment if new anticancer 
therapy is initiated must be reported to the sponsor (or designee).  The reporting of SAEs must be 
within 24 hours of learning of its occurrence, unless otherwise specified by the Protocol.  The 
investigator will submit any updated SAE data to the sponsor (or designee) immediately without 
undue delay but no later than within 24 hours of it being available.  
Investigators are not obligated to actively seek AE or SAE information after conclusion of the 
study participation.  However, if the investigator learns of any SAE, at any time after a 
participant has been discharged from the study, and he/she considers the event to be reasonably 
related to the study treatment or study participation, the investigator must notify the sponsor (or 
designee) immediately without undue delay but no later than within 24 hours of obtaining 
knowledge of its occurrence unless otherwise specified by the Protocol. 
After the initial AE/SAE report, the investigator is required to proactively follow each participant 
at subsequent visits/contacts.  All SAEs will be followed until resolution, stabilization, the event 
is otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). 
Prompt notification by the investigator to the sponsor of a SAE is essential so that legal 
obligations and ethical responsibilities towards the safety of participants and the safety of a study 
treatment under clinical investigation are met. 
If the SAE is not documented in the IB for the study drug (new occurrence) and is thought to be 
related to the sponsor's study drug, the sponsor or its designee may urgently require further 
information from the investigator for reporting to health authorities.  The sponsor or its designee 
may need to issue an Investigator Notification to inform all investigators involved in any study 
with the same drug that this SAE has been reported.  Suspected Unexpected Serious Adverse 
Reactions will be collected and reported to the competent authorities and relevant ethics 

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committees in accordance with Directive 2001/20/EC, or as per national regulatory requirements 
in participating countries. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study treatment under clinical investigation.  The 
sponsor will comply with country-specific regulatory requirements relating to safety reporting to 
the regulatory authority, IRB/IEC, and investigators. 
Investigator safety reports must be prepared for suspected unexpected adverse reactions 
according to local regulatory requirements and sponsor policy and forwarded to investigators as 
necessary. 
An investigator who receives an investigator safety report describing a SAE or other specific 
safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it 
along with the Investigator's Brochure and will notify the IRB/IEC, if appropriate according to 
local requirements. 
Serious Adverse Event Reporting 
• Information about all SAEs is collected and recorded on the Adverse Event Form in the eCRF. 
• The investigator must report within 24 hours of learning of its occurrence any SAE via the EDC 
system (primary method).  
• In circumstances in which the EDC system is not accessible for reporting SAE information (initial 
and/or follow-up SAE information) to the sponsor within 24 hours, refer to the Incyte Reference 
Guide for Completing and Submitting the Serious Adverse Event Report Form.  The contact 
information for Incyte Pharmacovigilance by email/fax is listed in the Incyte Reference Guide for 
Completing the Serious Adverse Event Report Form. 
• Once the EDC system is functional, the SAE report should be retrospectively added to the EDC 
system and follow-up should be completed through the EDC.  The original copy of the Serious 
Adverse Event Report Form and the email or facsimile confirmation sheet must be kept at the study 
site (refer to the Incyte Reference Guide for Completing the Serious Adverse Report Form for 
details). 
• Follow-up information is recorded through EDC (or on an amended or new Serious Adverse Event 
Report Form if the EDC system is not available with an indication that it is follow-up to the 
previously reported SAE and the date of the original report).  Refer to the eCRF guidelines for more 
information.  The follow-up report should include information that was not provided on the previous 
Serious Adverse Event Report Form, such as the outcome of the event (eg, resolved or ongoing), 
treatment provided, action taken with study drug because of the SAE (eg, dose reduced, interrupted, 
or discontinued), or participant disposition (eg, continued or withdrew from study participation).  
Each recurrence, complication, or progression of the original event should be reported as follow-up 
to that event, regardless of when it occurs.  
9.5. 
Adverse Events of Special Interest 
No specific AEs are expected to be sent to the sponsor within an expedited manner outside the 
AEs that meet the seriousness category as described in Section 9.  Adverse events of special 
interest will include irAEs that will be coded according to MedDRA along with all other adverse 
events.  Immune response AEs will be tabulated by preferred term and system organ class, and 
by events of Grade 3 or higher. 

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9.6. 
Emergency Unblinding of Treatment Assignment 
In a medical emergency, if knowledge of the treatment assignment is necessary to determine 
optimal medical management of the participant, the procedure for emergency unblinding is 
provided in the IRT.  This option may be used only if the participant's well-being requires the 
investigator to be aware of the participant's treatment assignment.  If a participant's treatment 
assignment is unblinded, the sponsor or its designee must be notified immediately by telephone. 
If an investigator, site personnel performing assessments, or participant is unblinded, the 
participant must be withdrawn from the study treatment, unless there are ethical reasons to have 
the participant remain on the study treatment.  In these cases, the investigator must obtain 
specific approval from the sponsor's (or its designee's) medical monitor for the participant to 
continue in the study. 
9.7. 
Pregnancy 
Pregnancy, in and of itself, is not regarded as an AE unless there is suspicion that study drug may 
have interfered with the effectiveness of a contraceptive medication or method.  When a 
pregnancy has been confirmed in a participant during maternal or paternal exposure to study 
drug, the following procedures should be followed in order to ensure safety: 
• The study treatment and study drug must be discontinued immediately (female 
participants only). 
• The investigator must complete and submit the Sponsor Clinical Trial Pregnancy 
Form to the sponsor or its designee within 24 hours of learning of the pregnancy. 
Data on fetal outcome are collected for regulatory reporting and drug safety evaluation.  
Follow-up should be conducted for each pregnancy to determine outcome, including spontaneous 
or voluntary termination, details of the birth, and the presence or absence of any birth defects, 
congenital abnormalities, or maternal and/or newborn complications, by following until the first 
well-baby visit.  Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported 
by the investigator to the sponsor or its designee.  Pregnancy follow-up information should be 
recorded on the same form and should include an assessment of the possible causal relationship 
to the sponsor's study drug to any pregnancy outcome, as well as follow-up to the first well-baby 
visit or the duration specified in local regulations, whichever is later.  Refer to the Incyte 
Reference Guide for Completing the Clinical Trial Pregnancy Form. 
Any SAE occurring during pregnancy of a study participant must be recorded on the 
Serious Adverse Event Report Form/SAE EDC and submitted to the sponsor or designee. 
Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, congenital 
anomalies, or ectopic pregnancy) are considered SAEs (if occurring in the study participant) and 
must be reported as described in Section 9.4.  If an abnormal pregnancy outcome is reported in a 
study participant's partner, the event should be reported to the sponsor on the Clinical Trial 
Pregnancy Form. 

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9.8. 
Warnings and Precautions 
Special warnings or precautions for the study drug, derived from safety information collected by 
the sponsor or its designee, are presented in the IB.  Special warnings or precautions to the 
chemotherapy agents used are found in Section 6.5 and Section 6.6 and are further detailed in the 
approved labels. 
Additional safety information regarding INCMGA00012 collected between IB updates will be 
communicated in the form of Investigator Notifications.  Any important new safety information 
should be discussed with the participant during the study, as necessary.  If new significant risks 
are identified, they will be added to the ICF. 
9.9. 
Product Complaints 
The sponsor collects product complaints on study drugs and drug delivery systems used in 
clinical studies in order to ensure the safety of study participants, monitor quality, and facilitate 
process and product improvements. 
All product complaints associated with material packaged, labeled, and released by the sponsor 
or its designee will be reported to the sponsor.  All product complaints associated with other 
study material will be reported directly to the respective manufacturer. 
The investigator or his/her designee is responsible for reporting a complete description of the 
product complaint via email or other written communication to the sponsor contact or respective 
manufacturer as noted in the packaging information.  Any AE associated with a product 
complaint should be recorded as described in Section 9.3. 
If the investigator is asked to return the product for investigation, he/she will return a copy of the 
product complaint communication with the product. 
9.10. 
Treatment of Overdose 
For this study, any dose of INCMGA00012 ≥ 1500 mg (4 times the 375 mg dose) within a 
24-hour time period (± 1 hour) will be considered an overdose. 
The sponsor does not recommend specific treatment for an overdose.  In the event of an overdose 
of INCMGA00012, the investigator should: 
• Contact the medical monitor and sponsor immediately. 
• Closely monitor the participant for any AE/SAE and laboratory abnormalities as per 
Section 9.3. 
• Document the quantity of the excess dose as well as the duration of the overdose in 
the eCRF. 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the medical monitor based on the clinical evaluation of the participant. 
There has been no clinical experience with overdose of INCMGA00012.  Treatment of overdose 
should consist of general supportive measures. 

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10. 
STATISTICS 
10.1. 
Sample Size Determination 
The study has a primary endpoint of OS with PFS as a secondary endpoint.  The overall 
population consists of participants with both nonsquamous and squamous NSCLC. 
Assumptions such as for HRs for PFS and OS from current clinical study results with 
pembrolizumab, atezolizumab, and nivolumab in combination with chemotherapy in the first line 
metastatic NSCLC setting were reviewed.  The HR of PFS varies from 0.48 to 0.64 in 
nonsquamous NSCLC participants and 0.56 to 0.71 in squamous NSCLC participants, while the 
HR of OS varies from 0.56 to 0.81 in the nonsquamous population and from 0.64 to 0.92 in the 
squamous population, respectively (Gandhi et al 2018, Hellmann et al 2019, Paz-Ares et al 2018, 
Socinski et al 2018). 
The study plans to enroll < 40% squamous NSCLC participants, which represents the prevalence 
of this histology in NSCLC and provides an adequate population from both disease groups (Mok 
et al 2019, NCI 2019).  Additionally, participants with tumors with PD-L1 TPS < 1% will be 
limited to < 30% for the same reason (Gandhi et al 2018, Mok et al 2019, Paz-Ares et al 2018).  
This capping is required 1) as the HR estimates were calculated based on previous clinical trials 
with similar distribution of the squamous and nonsquamous histologies and PD-L1 status of the 
tumors and 2) for study rigor and integrity. 
Combining the above median PFS and OS estimates in both nonsquamous and squamous 
disease, it is reasonable to assume the median PFS = 5 months in the chemotherapy arm and the 
target HR = 0.63 in the overall population.  Similarly, it is reasonable to assume the median 
OS = 14 months in the chemotherapy arm and the target HR = 0.7 in the overall population. 
For OS analysis, a target of 341 OS events will provide 87% power to detect an HR of 0.7 at a 
1-sided 2.5% significance level. 
For PFS analysis, a target of 222 PFS events will provide 90% power to detect an HR of 0.63 at a 
1-sided 2.5% significance level. 
The study design assumptions are based on randomization of approximately 530 participants in a 
2:1 ratio for INCMGA00012 plus chemotherapy arm and placebo plus chemotherapy arm, 
respectively.  The sample size estimation considers a recruitment period of 34 months at a 
uniform rate of 18 participants per month with a 6-month ramp-up period, a monthly withdrawal 
rate of 2% for PFS and 1% for OS from exponential distribution, and a follow-up period of 
20 months after the last participant is enrolled.  Due to potential early censoring attributable to 
the COVID-19 pandemic and/or disruptions in Ukraine, approximately 600 participants will be 
enrolled to ensure enough number of events will be observed within reasonable follow-up time.  
The sample size calculation is by East® v6.5. 
10.2. 
Populations for Analysis 
The populations to be analyzed are defined in Table 17. 

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Table 17: 
Populations for Analysis 
Population 
Description 
FAS 
The full analysis set comprises all participants to whom study treatment has been 
assigned by randomization.  Participants will be analyzed according to ITT 
principle (ie, according to the treatment and strata they have been assigned to 
during the randomization procedure). 
The FAS will be used for the summary of demographics, baseline characteristics, 
and participant disposition and for analyses of all efficacy data. 
PPS 
The PPS comprises all participants in the FAS who are considered compliant with 
the Protocol. 
Sensitivity analyses of OS may be performed using the PPS when the primary 
endpoint is statistically significant. 
Safety 
The safety population comprises all participants who received at least 1 dose of 
study treatment.  Treatment groups for this population will be determined by the 
actual treatment that the participant received regardless of treatment assignment at 
randomization. 
The actual treatment received corresponds to: 
• The randomized treatment if the participant took at least 1 dose of that 
treatment. 
• The first treatment received if the randomized treatment was never received. 
All safety analyses will be conducted by safety population. 
PK 
The PK evaluable population comprises all participants who received at least 1 dose 
of INCMGA00012 and have provided at least 1 PK postdose sample. 
10.3. 
Level of Significance 
The level of significance for the primary endpoint of OS and secondary endpoint PFS is strongly 
controlled at 1-sided 2.5% through gate-keeping procedure. For the OS endpoint, the Type I 
error will be controlled by a 1-sided, 2-look, group-sequential design with Lan-DemMets 
(O'Brien and Fleming 1979) alpha spending function.  If the OS test indicates statistical 
significance, PFS by RECIST v1.1 (via BICR) will be tested in an alpha-controlled manner.  The 
ORR by RECIST v1.1 (via BICR) will be tested at 2.5% if PFS is statistically significant. 
10.4. 
Statistical Analyses 
The SAP will be developed and finalized before database lock and will describe the participant 
populations to be included in the analyses, and procedures for accounting for missing, unused, 
and spurious data.  This section is a summary of the planned statistical analyses of the primary 
and secondary endpoints. 

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10.4.1. 
Primary Analysis 
Overall survival is defined as the time from the date of randomization to the date of death due to 
any cause.  The primary efficacy analysis of OS comparing the 2 treatment groups will be a 
stratified log-rank test at an overall 1-sided 2.5% level of significance based on the data observed 
in the FAS population, according to the treatment group participants were randomized and the 
strata they were assigned at randomization.  Kaplan-Meier curves, medians, and 95% CIs of the 
median OS will be presented for each treatment group. 
The HR for OS will be calculated, along with its 95% CI, from a stratified Cox model using the 
same stratification factors as for the log-rank test with Efron's likelihood approximation to 
account for ties in event times. 
In order to adjust for cross over effect in placebo arm, rank preserving structural failure time 
model and inverse probability of censoring weighting method may be used to analyze the OS 
endpoint as supportive analysis. Sensitivity analyses may be performed according to regulatory 
guidelines (EMA 2012, EMA 2022, FDA 2015) and will be detailed in the SAP. 
As a sensitivity analysis, an unstratified log-rank test may be considered for OS.  In addition, 
study discontinuation due to clinical progression, death, or documented progression by BICR 
after 2 missed scheduled tumor assessment may be considered as events for PFS in sensitivity 
analysis.  In addition, sensitivity analyses may be conducted to evaluate potential impacts of the 
COVID-19 pandemic (ie, deaths) and/or organizational disruptions in Ukraine (ie, conflict 
conditions in Ukraine). 
10.4.2. 
Subgroup Analyses 
To determine whether the treatment effect is consistent across various subgroups, the estimate of 
the between-group treatment effect (with a nominal 95% CI) for the OS and PFS endpoints will 
be estimated and plotted within each category of the following classification variables: 
• Age category (≤ 65 vs > 65 years, ≤ 75 vs > 75 years, and ≤ 85 vs > 85 years) 
• Sex (female, male) 
• Race (White, Chinese, other Asian, Other) 
• Brain metastasis (presence vs absence) 
• Smoking status (never vs former/current smoker) 
• Investigator's choice of chemotherapy (for nonsquamous NSCLC vs squamous 
NSCLC) 
• PD-L1 TPS (< 1%, ≥ 1% to 49%, ≥ 50%) 
• Site geographic region (East Asia vs non-East Asia) 
• Country enrollment (eg, China, Ukraine, and any countries with ≥ 100 participants 
randomized vs all other countries combined) 
• Predominant tumor histology (squamous vs nonsquamous) 

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10.4.3. 
Secondary Analyses 
10.4.3.1. Progression-Free Survival 
Progression-free survival is defined as the time from the date of randomization to the date of the 
first documented progression or death due to any cause.  Progression-free survival will be 
assessed via BICR according to RECIST v1.1 (Eisenhauer et al 2009).  Survival data will be 
analyzed by the Kaplan Meier method, treating participants with no observed death or disease 
progression as censored at the date of the last adequate tumor assessment.  Censoring for PFS 
will follow the algorithm outlined in Table 18.  Progression-free survival as assessed via 
investigator may be used for supportive analysis of the primary endpoint.  
Table 18: 
Evaluation and Censoring of Progression-Free Survival 
Situation 
Outcome 
Date of Progression or Censoring 
No baseline tumor assessments 
Censored 
Date of randomization 
Progression documented between 
scheduled visits 
Progressed 
Date of first disease assessment of PD 
No progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
Study discontinuation for 
undocumented progression 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
New anticancer treatment started 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) before new anticancer 
treatment 
Death before first progressive 
disease assessment 
Progressed 
Date of death 
Death between adequate 
assessment visits 
Progressed 
Date of death 
Death after 1 missed assessment 
Progressed 
Date of death 
Progression after 1 missed 
assessment 
Progressed 
Date of first objective response of PD 
Death or progression after more 
than 1 missed assessment 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing)  
If the OS endpoint is tested as statistically significant, PFS will be analyzed using a stratified 
log-rank test at an overall 1-sided 2.5% level of significance based on the data observed in the 
FAS population, according to the treatment group participants were randomized and the strata 
they were assigned at randomization.  The distribution of PFS will be estimated using the 
Kaplan-Meier method.  The median PFS along with 95% CIs will be presented by treatment 
group. 
A stratified Cox regression with Efron's method for tie-handling will be used to estimate the HR 
of PFS, along with 95% CIs, using the same strata information assigned at randomization.  The 
analysis of PFS will be conducted at the time of the OS interim analysis. The p-value will be a 
nominal p-value if OS is not statistically significant at the time of interim analysis.  

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10.4.3.2. Objective Response Rate 
Objective response rate is defined as the proportion of participants with best objective response 
of CR or PR according to RECIST v1.1 by BICR.  Objective response rate by iRECIST is not an 
endpoint; iRECIST is used for participant's disease management.  Objective response rate will be 
calculated based on the FAS according to the ITT principle.  Objective response rate will be 
presented by treatment group along with approximate 95% CI.  The Cochran-Mantel-Haenszel 
chi-square test (stratum based on the baseline stratification factor) will be used to compare the 
2 treatment groups with respect to the ORR at a 1-sided 2.5% level of significance if OS and PFS 
are both statistically significant.  As a supportive analysis, ORR as assessed by the investigator 
will be calculated by treatment group and presented along with the approximate 95% CI. 
10.4.3.3. Duration of Response 
For participants who demonstrate CR or PR, DOR is defined as the time from first documented 
evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.  
Censoring rules for DOR are summarized in Table 19.  Duration of response will be assessed 
using RECIST v1.1 by BICR.  The distribution of DOR will be estimated using the 
Kaplan-Meier method.  The median DOR along with 95% CIs will be presented by treatment 
group. 
For each DOR analysis, a corresponding summary of the reasons responding participants are 
censored will also be provided.  Responses in participants who are alive, have not progressed, 
have not initiated new anticancer treatment, and have not been determined to be lost to follow-up 
are considered ongoing at the time of analysis.  If a participant meets multiple criteria for 
censoring, the censoring criterion that occurs earliest will be applied. 
Table 19: 
Evaluation and Censoring of Duration of Response 
Situation 
Outcome 
Date of Progression or Censoring 
No progression or death, new 
anticancer treatment not started 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) 
No progression or death, new 
anticancer treatment started 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) before new anticancer 
treatment 
Death or progression after 
≥ 2 consecutive missed 
assessments 
Censored 
Date of last valid radiologic assessment 
(not NE and not missing) before ≥ 2 missing 
assessments 
Death or progression after 
≤ 1 missed adequate assessments 
Progressed 
Date of first objective response of progressive 
disease or death 
10.4.4. 
Safety Analyses 
Safety analyses will be conducted for the safety population by treatment group and by histology. 

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10.4.4.1. Adverse Events 
A TEAE is any AE either reported for the first time or worsening of a pre-existing event after 
first dose of study treatment, up to 90 days after last dose of study treatment, and prior to start of 
new anticancer therapy.  Analysis of AEs will be limited to TEAEs, but data listings will include 
all AEs regardless of their timing to study treatment administration. 
Adverse events will be tabulated by MedDRA system organ class and preferred term.  Severity 
of AEs will be based on the NCI CTCAE v5.0 using Grades 1 through 5.  The subset of AEs 
considered by the investigator to have a relationship to study treatment will be considered to be 
treatment-related AEs.  If the investigator does not specify the relationship of the AE to study 
treatment, the AE will be considered treatment-related. 
Number (%) of participants reporting any TEAEs, any SAEs, any Grade 3 or higher TEAEs, 
irAEs, clinically diagnosed Hy's Law AEs, any treatment-related TEAEs, any treatment-related 
SAEs, any treatment-related Grade 3 or higher TEAEs, any fatal TEAE, and any TEAEs leading 
to treatment interruption/dose reduction/discontinuation will be tabulated by MedDRA system 
organ class and preferred term. 
10.4.4.2. Clinical Laboratory Tests 
The clinical laboratory data will be analyzed using summary statistics.  In addition, distributions 
of key laboratory parameters may be plotted over time; these values will also be classified into 
CTCAE toxicity grades and tabulated.  Potential DILIs will be listed.  The criteria for 
determining potential DILIs will be provided in the Statistical Analysis Plan. 
Laboratory test values outside the normal range will be assessed for severity based on the normal 
ranges for the clinical reference laboratory.  The incidence of abnormal laboratory values and 
shift tables relative to baseline will be tabulated.  The following summaries will be produced for 
the laboratory data: 
• Number and percentage of participants with worst postbaseline CTCAE grade 
(regardless of baseline value).  Each participant will be counted only for the worst 
grade observed postbaseline. 
• Shift tables from baseline to the worst postbaseline value using CTCAE grade. 
• For laboratory parameters where CTCAE grades are not defined, shift tables to the 
worst postbaseline value using the low/normal/high classification based on laboratory 
reference ranges. 
10.4.4.3. Vital Signs 
Descriptive statistics and mean change from baseline will be determined for vital signs (blood 
pressure, pulse, respiratory rate, and body temperature) at each assessment time.  Vital sign 
results will be reviewed for clinically notable abnormalities, and participants exhibiting clinically 
notable vital sign abnormalities will be listed. 
10.4.4.4. Electrocardiograms 
Descriptive statistics and mean change from baseline will be determined for each ECG parameter 
at each assessment time. 

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10.4.4.5. Dose Exposure 
Measures of exposure (eg, days of exposure, dose intensity) of INCMGA00012 and 
chemotherapy by histology and by treatment group will be summarized by means of summary 
statistics. 
10.4.4.6. Pharmacokinetics 
The INCMGA00012 PK will be described using a population PK modeling approach software 
(eg, NONMEM) following unblinding of the study.  If there is not sufficient data, data from this 
study will be pooled with data from other studies for a population PK analysis. 

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10.5. 
Interim Analysis 
An interim analysis for OS is planned when approximately 60% of the targeted OS events are 
expected.  Under the assumption of 14-month median OS in the placebo plus chemotherapy arm, 
it is expected that treatment with INCMGA00012 plus chemotherapy will result in a 30% 
reduction in HR (corresponding to an increase in median OS from 14 months to 20 months under 
exponential model assumption).  If the true HR is 0.7 (under alternative hypothesis), a total of 
341 OS events are required to have 87% power at a 1-sided overall 2.5% level of significance to 
reject the null hypothesis (HR = 1) using a log-rank test and a 2-look group sequential design 
with Lan-DeMets (O'Brien and Fleming 1979) alpha spending function to determine efficacy 
stopping boundary.  Considering a recruitment period of 34 months at a uniform rate of 
18 participants/month with a 6-month ramp-up period and 20-month minimum follow-up, 
approximately 530 participants were planned for randomization in a 2:1 ratio.  Due to potential 
early censoring from Ukraine participants, approximately 600 participants will be enrolled to 
ensure enough number of events will be observed within reasonable follow-up time. 
The primary intent of the interim analysis is to stop early for outstanding efficacy.  
Table 20 presents stopping boundary at a 1-sided 2.5% level of significance based on current 
projection.  The boundary will be recalculated at the time of interim analysis if some 
assumptions are violated. 

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Table 20: 
Guidelines for Decisions in Overall Survival Endpoint 
 
Interim Analysis 
Final Analysis 
Number of eventsa 
205 
341 
Decision outcome 
Continue With 
Sponsor Blinded 
Continue With 
Sponsor Unblinded 
Futility 
Efficacy 
One-sided p-value 
> 0.004 
< 0.004 
> 0.024 
 0.024 
Estimated hazard rate 
reduction 
< 32.7% 
> 32.7% 
< 20.4% 
 20.4% 
Estimated median 
improvement (month) 
< 6.8 
> 6.8 
< 3.6 
 3.6 
Note: Estimates are based on randomized participants and on original exponential assumptions in which median OS 
is 14 months on control and 20 months on INCMGA00012 with the analysis. Enrollment is projected as 
18 participants per month. 
a Total number of events in participants from both control and INCMGA00012 arms. 
Preplanned analyses of safety and efficacy will be provided to an eDMC as specified in the 
eDMC Charter.  See Section 5.5 for details on the eDMC role, their review of data, eDMC 
meetings, and composition. 
The SAP will describe all planned analyses and safety data reviews in greater detail. 

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11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
11.1. 
Investigator Responsibilities 
• The Protocol, Protocol Amendments, ICF, IB, and other relevant documents 
(eg, advertisements) must be submitted to an IRB/IEC by the investigator and 
reviewed and approved by the IRB/IEC and health authorities before the study is 
initiated. 
• The investigator is responsible for ensuring that the safety reports provided by the 
sponsor are reviewed and processed in accordance with regulatory requirements, the 
policies and procedures established by the IRB/IEC, and institutional requirements. 
• Any amendments to the Protocol will require approval from both health authorities 
and the IRB/IEC before implementation of changes made to the study design, except 
for changes necessary to eliminate an immediate hazard to study participants. 
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC. 
− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures. 
− Providing oversight of the conduct of the study at the site and adherence to GCP, 
IRB/IEC requirements, institutional requirements, and applicable laws and 
country-specific regulations. 
• Adhering to the Protocol as described in this document and agreeing that changes to 
the Protocol procedures, with the exception of medical emergencies, must be 
discussed and approved, first, by the sponsor or its designee and, second, by the 
IRB/IEC.  Each investigator is responsible for enrolling participants who have met 
the specified eligibility criteria. 
• Retaining records in accordance with all local, national, and regulatory laws but for a 
minimum period of at least 2 years after the last marketing application approval in an 
ICH region and until there are no pending or contemplated marketing applications in 
an ICH region, or if not approved, 2 years after the termination of the test article for 
investigation to ensure the availability of study documentation should it become 
necessary for the sponsor or a regulatory authority to review. 
− The investigator must not destroy any records associated with the study during the 
retention period without receiving approval from the sponsor.  The investigator 
must notify the sponsor or its designee in the event of accidental loss or 
destruction of any study records.  If the investigator leaves the institution where 
the study was conducted, the sponsor or its designee must be contacted to arrange 
alternative record storage options. 

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− All eCRF data entered by the site (including audit trail), as well as computer 
hardware and software (for accessing the data), will be maintained or made 
available at the site in compliance with applicable record retention regulations.  
The sponsor will retain the original eCRF data and audit trail. 
11.1.1. 
Identification of the Coordinating Principal Investigator 
A coordinating principal investigator will be appointed by the sponsor before the end of the 
study.  As part of their responsibilities, the coordinating principal investigator will review the 
final CSR.  Agreement with the final CSR will be documented by the dated signature of the 
coordinating principal investigator. 
11.2. 
Data Management 
Data management will be performed in a validated EDC system.  The investigator will be 
provided with access to an EDC system so that an eCRF can be completed for each participant. 
The site will be provided with eCRF completion guidelines for instructions on data entry in the 
eCRF.  The study monitor will reference the Monitoring Plan in order to ensure that each issue 
identified is appropriately documented, reported, and resolved in a timely manner in accordance 
with the plan's requirements.  Other data outside the EDC system required in the study conduct 
of the Protocol, such as documents or results transmitted to the sponsor via a central laboratory 
or specialized technical vendors and as designated by the sponsor, will have their own data flow 
management plans, or study charters, or 
 plans, as applicable. 
The sponsor (or designee) will be responsible for the following: 
• Managing the integrity of the data and the quality of the conduct of the study, such as 
ensuring that study monitors perform ongoing source data verification to confirm that 
data entered into the eCRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved Protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements. 
• Managing and reconciling the data generated, and/or collected, including documents 
and results such as laboratory or imaging data analyzed centrally by a designated 
vendor of the sponsor. 
The investigator will be responsible for the following: 
• Recording, or ensuring the recording of, all relevant data relating to the study in the 
eCRF. 
• Delivering, or ensuring the delivery of, all other results, documents, data, know-how, 
or formulas relating to the study to the sponsor or designee electronically and/or 
centrally (eg, laboratory data, imaging data, 
 data, photographs, diary data), 
or as otherwise specified in the Protocol. 

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• Maintaining adequate and accurate source documents and trial records that include all 
pertinent observations on each of the site's trial participants. Source data should be 
attributable, legible, contemporaneous, original, accurate, and complete. Changes to 
source data should be traceable, should not obscure the original entry, and should be 
explained if necessary (eg, via an audit trail). Source data are, in general, all 
information in original records and certified copies of original records of clinical 
findings, observations, or other activities in a clinical trial necessary for the 
reconstruction and evaluation of the trial. Source data are contained in source 
documents (original records or certified copies). 
• Verifying that data entries are accurate and correct by physically or electronically 
signing the eCRF. 
• Maintaining accurate documentation (source data) that supports the information 
entered in the eCRF, or sent to a central vendor designated by the sponsor, or as 
described in other study and data flow manuals. 
− Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected.  Source documents are filed at the 
investigator's site.  Examples of source documents are original documents, data, 
and records (eg, hospital records; electronic hospital records; clinical and office 
charts; laboratory notes; memoranda; participants' diaries or evaluation checklists; 
pharmacy dispensing records; recorded data from automated instruments; copies 
or transcriptions certified after verification as being accurate copies; microfiches; 
photographic negatives; microfilm or magnetic media; x-rays; participants' files; 
and e-records/records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial). 
− Data entered in the eCRF that are transcribed from source documents must be 
consistent with the source documents or the discrepancies must be explained.  The 
investigator may need to request previous medical records or transfer records, 
depending on the study.  Current applicable medical records must be available. 
• Sending participants' data, either as unique samples, copies, or photographs, to be 
evaluated centrally or analyzed centrally, or both, by a qualified vendor designated by 
the sponsor. 
− As required by privacy and data protection regulations and Incyte's privacy 
policies, if any photographs of participants are to be taken, the photographs must 
be limited to the area of the face or the body that is strictly necessary and the 
photographs should be masked (ie, identifying features such as eyes, mouth, scars, 
tattoos, or unique markings or features should be either obscured with a black bar 
or digitally pixelated so as to not permit the reidentification of the participants and 
preserve their confidentiality) by a specially designated photography vendor prior 
to sending the photographs to Incyte or any other third-party vendors for analysis 
or further processing. 

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• Permitting study-related monitoring, sponsor audits, IRB/IEC review, and regulatory 
inspections by providing direct access to source data and other relevant clinical study 
documents. 
− Monitoring:  Qualified representatives of the sponsor or its designee, study 
monitors, will monitor the study according to a predetermined plan.  The 
investigator must allow the study monitors to review any study materials and 
participant records at each monitoring visit. 
− Auditing:  Qualified representatives of the sponsor or its designee may audit the 
clinical study site and study data to evaluate compliance with the Protocol, 
applicable local clinical study regulations, and overall study conduct.  The 
investigator must allow the auditors to review original source records and study 
documentation for all participants. 
− Regulatory inspection:  Regulatory authorities may conduct an inspection of the 
study and the site at any time during the development of an investigational 
product.  The investigator and staff are expected to cooperate with the inspectors 
and allow access to all source documents supporting the eCRFs and other 
study-related documents.  The investigator must immediately notify the sponsor 
when contacted by any regulatory authority for the purposes of conducting an 
inspection. 
11.3. 
Data Quality Assurance 
The sponsor assumes accountability for actions delegated to other individuals (eg, contract 
research organizations). The sponsor or designee is responsible for the data management of this 
study, including quality checking of the data. Further, 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, Protocol deviations, and monitoring techniques (eg, central, remote, or 
on-site monitoring) are provided in the monitoring plan or equivalent. 
Quality tolerance limits will be predefined in the operational manual or equivalent to identify 
systematic issues that can impact participant's safety, efficacy results and analysis, and/or 
reliability of study results.  These predefined parameters will be monitored during the study and 
can be adjusted during the study upon data review.  Important deviations from the quality 
tolerance limits and remedial actions taken, including reporting to IRBs/IECs and health 
authorities if applicable, will be summarized in the CSR. 
11.4. 
Data Privacy and Confidentiality of Study Records 
The investigator and the sponsor or its designee must adhere to applicable data protection laws 
and regulations.  The investigator and the sponsor or its designee are responsible for ensuring 
that sensitive personal information is handled in accordance with local data protection laws 
(including but not limited to HIPAA and GDPR) as applicable, and the sponsor operates 
comprehensive data privacy and data security programs that are applicable to this study.  
Appropriate notice, or notice and consent (as may be required by each applicable jurisdiction), 

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for collection, use, disclosure, and/or transfer (if applicable) of personal information must be 
obtained in accordance with local data protection laws. Appropriate data protection terms that 
comply with applicable laws will be included in relevant study agreements. 
To ensure confidentiality of records and protect personal data, participant names will not be 
supplied to the sponsor or its designee.  Only the participant number will be recorded in the 
eCRF; if the participant's name appears on any other document (eg, laboratory report), it must be 
obliterated on the copy of the document to be supplied to the sponsor or its designee.  Study 
findings stored on a computer will be stored in accordance with appropriate technical and 
organizational measures as required by local data protection laws. 
Biological samples will be stored under secured conditions (ie, locked with limited access by 
authorized individuals at a laboratory facility designated by the sponsor) for up to 10 years from 
the first clinical study report publication.  After this storage period, remaining samples will be 
destroyed according to most recent biospecimen guidance at that facility.  Only researchers at the 
study site or a laboratory designated by the sponsor will have access to and use of biological 
samples.  
 
 
 
 
In the event of a data breach involving participant data, the sponsor or its designee will follow 
the sponsor's incident response procedures.  The precise definition of a data breach varies in 
accordance with applicable law but may generally be understood as a breach of security leading 
to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to, 
personal data.  In accordance with its incident response procedures, the sponsor will assess the 
breach to consider its notification and remediation obligations under applicable law. 
11.5. 
Financial Disclosure 
Before study initiation, all clinical investigators participating in clinical studies subject to FDA 
Regulation Title 21 CFR Part 54 – Financial Disclosure by Clinical Investigators (ie, "covered 
studies") are required to submit a completed Clinical Investigator Financial Disclosure form that 
sufficiently details any financial interests and arrangements that apply.  For the purpose of this 
regulation, "clinical investigator" is defined as any investigator or subinvestigator who is directly 
involved in the treatment or evaluation of research participants, including the spouse and each 
dependent child of the clinical investigator or subinvestigator.  These requirements apply to both 
US and foreign clinical investigators conducting covered clinical studies. 
Any new clinical investigators added to the covered clinical study during its conduct must also 
submit a completed Clinical Investigator Financial Disclosure Form.  During a covered clinical 
study, any changes to the financial information previously reported by a clinical investigator 
must be reported to the sponsor or its designee.  At the conclusion of the covered clinical study, 
the clinical investigators will be reminded of their obligations.  In the event that the clinical 
investigator is not reminded, they nevertheless will remain obligated to report to the sponsor or 
its designee any changes to the financial information previously reported, as well as any changes 
in their financial information for a period of 1 year after completion of the covered clinical study. 

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11.6. 
Publication Policy 
By signing the study Protocol, the investigator and his/her institution agree that the results of the 
study may be used by the sponsor, Incyte Corporation (Incyte), for the purposes of national and 
international registration, publication, and information for medical and pharmaceutical 
professionals.  Study results will be published in accordance with applicable local and national 
regulations.  If necessary, the authorities will be notified of the investigator's name, address, 
qualifications, and extent of involvement.  The terms regarding the publication of study results 
are contained in the agreement signed with the sponsor or its designee.  A signed agreement will 
be retained by the sponsor or its designee. 
The results of this study may be published or presented at scientific meetings.  If this is foreseen, 
the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission.  
This allows the sponsor to protect proprietary information and to provide comments. 
The sponsor will comply with the requirements for publication of study results.  In accordance 
with standard editorial and ethical practice, the sponsor will generally support publication of 
multicenter studies only in their entirety and not as individual site data.  In this case, a 
coordinating investigator will be designated by mutual agreement. 
Authorship will be determined in line with International Committee of Medical Journal Editors 
authorship requirements. 
11.7. 
Compliance With Trial Registration and Results Posting 
Requirements 
The sponsor of the trial is solely responsible for determining whether the trial and its results are 
subject to the requirements for submission to clinicaltrials.gov, clinicaltrialsregister.eu, or other 
local and/or national registries.  The results of the study endpoints will be posted for the public 
and participants in national and local clinical trial registries such as clinicaltrials.gov as per 
current requirements and format from registries.  Information posted will allow participants to 
identify potentially appropriate trials for their disease conditions and pursue participation by 
calling a central contact number for further information on appropriate trial locations and trial 
site contact information.  These websites will not include information that can identify 
participants.  
 
 
11.8. 
Study and Site Closure 
The sponsor or designee reserves the right to close the study site or terminate the study at any 
time for any reason at the sole discretion of the sponsor.  Study sites will be closed upon study 
completion.  A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 

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The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the Protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines. 
• Inadequate recruitment of participants by the investigator. 
• Discontinuation of further study treatment development. 

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12. 
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European Medicines Agency. Points to consider on the impact of the war in Ukraine on 
methodological aspects of ongoing clinical trials. 2022. 
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patients with cancer. Accessed December 7, 2021. https://www.esmo.org/covid-19-and-
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Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, 
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controlled trial. Lancet 2016;387:1540-1550. 
Horn L, Whisenant J, Torri V, et al. Thoracic Cancers International COVID-19 Collaboration 
(TERAVOLT): impact of type of cancer therapy and COVID therapy on survival. J Clin Oncol 
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INCMGA00012 Investigator's Brochure. Wilmington, DE: Incyte Corporation. 
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Jotte RM, Cappuzzo F, Vynnychenko I, et al. IMpower131: primary PFS and safety analysis of a 
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Lakhani N, Mehnert JM, Rasco D, et al. A Phase 1 study of the safety, tolerability, and 
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November 8-12, 2017; National Harbor, MD. Abstract P249. 
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Schmid P, Adams S, Rugo HS, et al. Atezolizumab and nab-paclitaxel in advanced 
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APPENDIX A. IMPORTANT INFORMATION REGARDING 
EFFECTIVENESS OF CONTRACEPTIVE METHODS 
For male participants in the study: 
Male participants should use a condom from screening through 120 days after the end of systemic 
exposure for INCMGA00012 and 180 days after INCMGA00012 plus chemotherapy.  If the male 
participant has a partner that is of childbearing potential, the partner should also use contraception 
through the same time period as noted above after the end of relevant systemic exposure.  In addition, 
male participants must refrain from donating sperm. 
Note:  Males who have had a vasectomy qualify as having met the requirement for a highly effective 
birth control method if he has received medical assessment of the surgical success. 
Contraception Requirements for Male Participants 
Male participants with female partners of childbearing potential are eligible to participate if they agree 
to 1 of the following during the Protocol-defined time frame: 
• Be abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a 
long-term and persistent basis) and agree to remain abstinent.  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 treatments/protocol-defined periods.  The reliability of 
sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the 
preferred and usual lifestyle of the participant. 
• Use a male condom plus partner use of an additional contraceptive method when having penile-
vaginal intercourse with a woman of childbearing potential who is not currently pregnant. 
– 
-The following are not acceptable methods of contraception: 
▪ 
Periodic abstinence (eg, calendar, symptothermal, post-ovulation methods), withdrawal 
(ie, coitus interruptus), spermicides only, and lactational amenorrhea method. 
▪ 
Male condom with cap, diaphragm or sponge with spermicide. 
▪ 
Male and female condom used together. 
Note:  Men 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. 
For female participants in the study: 
The following methods that can achieve a failure rate of less than 1% per year when used consistently 
and correctly are considered as highly effective birth control methods:  
• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition 
of ovulationa 
– 
oral 
– 
intravaginal 
– 
transdermal 
• Progestogen-only hormonal contraception associated with inhibition of ovulationa 
– 
oral 
– 
injectable 
– 
implantableb 
• Intrauterine deviceb 
• Intrauterine hormone-releasing systemb 
• Bilateral tubal occlusionb 
• Vasectomized partnerbc 
• Sexual abstinenced 

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Woman of Childbearing Potential 
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below). 
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 no menses for 12 months without an alternative medical 
cause. 
▪ 
A high FSH level in the postmenopausal range may be used to confirm a postmenopausal 
state in women not using hormonal contraception or HRT.  However, in the absence of 
12 months of amenorrhea, confirmation with 2 FSH measurements in the postmenopausal 
range is required. 
Note:  Females on HRT whose menopausal status is in doubt will be required to use 1 of the 
nonhormonal highly effective contraception methods if they wish to continue their HRT during the 
study.  Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before 
study enrollment. 
a Hormonal contraception may be susceptible to interaction with the investigational medicinal product, which may 
reduce the efficacy of the contraception method. 
b Contraception methods that in the context of this guidance are considered to have low user dependency. 
c Vasectomized partner is a highly effective method of avoiding pregnancy provided that partner is the sole sexual 
partner of the WOCBP study participant and that the vasectomized partner has received medical assessment of the 
surgical success. 
d In the context of this guidance, 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 treatments.   
Source:  Clinical Trials Facilitation and Coordination Group (2014 and 2020). 

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APPENDIX B. MASCC/ESMO ANTIEMETIC GUIDELINES 
Dexamethasonea 
Dose and Schedule 
High Risk 
Acute emesis 
20 mg once 
[12 mg when used with (fos)aprepitant or netupitant]b 
Delayed emesis 8 mg BID for 3-4 days 
[8 mg once daily when used with (fos)aprepitant or netupitant] 
Moderate risk 
Acute emesis 
8 mg once 
Delayed emesis 8 mg BID for 2-3 days (can also give the dose as 4 mg BID) 
Low risk 
Acute emesis 
4-8 mg once 
Note:  Investigators may use local equivalents, and should check for most recent updates if available, at mascc.org 
a While corticosteroids other than dexamethasone are effective antiemetics, the dose and schedule of dexamethasone 
coupled with its wide availability in various dose forms established it as the guideline agent of choice (Rolia 
et al 2016) 
b 12 mg dose of dexamethasone is the only one tested with (fos)aprepitant/netupitant in large randomized trials. 

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APPENDIX C. CALCULATED CREATININE CLEARANCE 
Original, Weight-Based Cockcroft and Gault Formula for Calculated CrCl for Men 
For serum creatinine concentration in mg/dL: 
CrCl (mL/min) = 
(140 – agea) × (wtb) × 1.0 
72 × serum creatinine (mg/dL) 
For serum creatinine concentration in μmol/L: 
CrCl (mL/min) = 
(140 – agea) × (wtb) × 1.0 
0.81 × serum creatinine (μmol/L) 
Original, Weight-Based Cockcroft and Gault Formula for Calculated CrCl for Women 
For serum creatinine concentration in mg/dL: 
CrCl (mL/min) = 
(140 – agea) × (wtb) × 0.85 
72 × serum creatinine (mg/dL) 
For serum creatinine concentration in μmol/L: 
CrCl (mL/min) = 
(140 – agea) × (wtb) × 0.85 
0.81 × serum creatinine (μmol/L) 
a Age in years. 
b Weight in kilograms. 
Source:  Cockcroft and Gault 1976. 

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APPENDIX D. CLINICAL LOCAL LABORATORY TESTS 
Blood Chemistries 
Hematology 
Urinalysis 
Serology 
Coagulation 
Albumin 
Alkaline phosphatase 
ALT/SGPT 
AST/SGOT 
Amylase 
Either bicarbonate or 
CO2a 
Blood urea nitrogen or 
urea 
Calcium 
Chloride 
Creatinine 
CrCl or GFR 
Glucose 
Lactate 
dehydrogenase 
Lipase 
Magnesium 
Phosphate 
Potassium 
Sodium 
Total bilirubin 
Direct bilirubin (if 
total bilirubin is 
elevated above 
ULN) 
Total protein 
Complete blood 
count, including: 
• Hemoglobin 
• Hematocrit 
• Platelet count 
• Red blood cell 
count 
• White blood 
cell count 
 
Differential count, 
including: 
• Basophils 
• Eosinophils 
• Lymphocytes 
• Monocytes 
• Neutrophils 
 
Absolute values 
must be provided 
for: 
• WBC 
differential 
laboratory 
results 
• Specific gravity 
• pH 
• (Qualitative is 
allowed): 
glucose, 
protein, occult 
blood, ketones, 
bilirubin, 
urobilinogen, 
nitrite, 
leukocytes 
 
Microscopic 
examination (if 
blood or protein is 
abnormal) 
Hepatitis B tests 
• HBsAg 
• HBV DNA 
Hepatitis C tests 
• HCV antibody 
• HCV-RNA 
quantitative or 
qualitative 
• HCV antibody 
test alone (only) 
is acceptableb if 
HCV RNA test 
cannot be done 
additionally per 
local SOC  
HIV test 
• HIV RNA (only if 
required by local 
regulation or health 
authorities) 
PT 
PTT or aPTT 
INR 
 
(PTT may be 
performed if the 
local lab is unable to 
perform aPTT) 
Endocrine Function 
Pregnancy Testing 
TSH, FT4, and T3 or 
FT3.  Total T3 is 
preferred; if not 
available Free T3 
may be tested. 
Human chorionic 
gonadotropin  
SARS-CoV-2 Tests 
SARS-CoV-2 tests 
(including types of 
approved tests) as per 
local clinical practice 
guidelines, standards, 
and/or evolving 
needs of the 
COVID-19 pandemic 
or variations. 
Notes:  Tests are performed locally; if particular analytes may not feasible locally, the sponsor will arrange for those tests to be 
performed centrally.  Additional tests (eg, ILD, tuberculosis) may be performed at any time during the study as determined 
necessary by the investigator or required by local regulations, or required by regions, or based on emerging safety data, or 
depending on the extent of COVID-19 pandemic.  Amylase, lipase, and endocrine tests and other specific laboratory tests may 
be performed more frequently for management of irAE toxicities and can be sent for testing to the sponsor's central laboratory 
upon request if local site testing is not available. 
a Perform if available as standard of care in your region (if these tests are not done as part of standard of care in your region then 
these tests do not need to be performed).  Also, carbon dioxide may be either a measurement of CO2 or bicarbonate as an 
electrolyte per institutional standard (it is not required to perform both of these laboratory tests). 
b Both HCV antibody test and HCV-RNA tests are required to determine eligibility for Hepatitis C. In countries where 
HCV-RNA test cannot be done per local SOC, then HCV antibody test alone is acceptable to determine eligibility. 

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APPENDIX E. EASTERN COOPERATIVE ONCOLOGY GROUP 
PERFORMANCE STATUS 
Grade 
ECOG Performance Status 
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 self-care but unable to carry out any work activities; up and 
about more than 50% of waking hours 
3 
Capable of only limited self-care; confined to bed or chair more than 50% of waking hours 
4 
Completely disabled; cannot carry on any self-care; totally confined to bed or chair 
5 
Dead 
Source:  Oken et al 1982. 

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APPENDIX F. TREATMENT AND IMAGING AFTER EVIDENCE OF 
PROGRESSIVE DISEASE WITH iRECIST 
The decision to continue treatment after iUPD is observed is at the investigator's discretion and 
should be based on the clinical status of the participant as described in the table below.  If PD is 
confirmed by iRECIST, participants will be discontinued from study treatment. 
Every effort should be made to continue monitoring their disease status by radiologic imaging 
until the participant has iCPD, starts a new anticancer therapy, withdraws consent, or dies.  If a 
follow-up scan was not performed after unconfirmed PD (eg, due to participant refusal or 
participant death), the initial date of unconfirmed progression will be considered the date of PD. 
Table F1: Imaging and Treatment After Radiologic Evidence of Progressive Disease 
 
Clinically Stable 
Clinically Unstable 
Imaging 
Treatment 
Imaging 
Treatment 
Initial 
unconfirmed PD 
by RECIST 
v1.1 (iUPD) OR 
subsequent 
iUPD after iSD, 
iPR or iCR 
Repeat imaging at 
≥ 4 and ≤ 8 weeks 
to confirm PD. 
May continue study 
treatment at the 
investigator's discretion 
while awaiting 
confirmatory scan. 
Repeat imaging at 
≥ 4 weeks and 
≤ 8 weeks to 
confirm PD if 
possible. 
Discontinue Treatment 
Next evaluable 
scan confirms 
PD (iCPD) 
No additional 
imaging required. 
Discontinue treatment. 
No additional 
imaging required. 
Not applicable 
Confirmation 
scan shows 
iUPD, iSD, iPR, 
or iCRa 
Continue regularly 
scheduled imaging 
assessments every 
8 weeks for the 
first 12 month after 
the start of 
treatment and then 
every 12 weeks 
(± 14 days) 
thereafter. 
Continue study 
treatment at the 
investigator's 
discretion. 
Continue regularly 
scheduled imaging 
assessments every 
8 weeks for the 
first 12 month after 
the start of 
treatment and then 
every 12 weeks 
(± 14 days) 
thereafter. 
May restart study 
treatment if condition 
has improved and/or is 
clinically stable per 
investigator's 
discretion. 
a iSD, iPR, and iCR is based on baseline or nadir. 

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In determining whether the tumor burden has increased or decreased, investigators should 
consider all baseline and any new target lesions as well as baseline and any new nontarget 
lesions.  Progressive disease (iCPD) is confirmed if further increase in tumor burden, compared 
to the last assessment, is seen as evidenced by 1 or more of the following: 
• Continued increase in tumor burden (from iUPD) where RECIST v1.1 definitions of 
progression had been met (from nadir) in target, nontarget disease or new lesions 
− Progression in target disease worsens with an increase of at least 5 mm in the 
absolute value of the sum;  
− Continued unequivocal progression in nontarget disease with an increase in tumor 
burden; 
− Increase in size of previously identified new lesion(s) (an increase of at least 
5 mm in the absolute value of the sum of those considered to be target new 
lesions) or additional new lesions  
• RECIST v1.1 criteria are met in lesions types (target or nontarget or new lesions) 
where progression was not previously identified, including the appearance of 
additional new lesions.  
If iUPD is not confirmed at the next assessment, then the appropriate response will be assigned 
(iUPD if the criteria are still met, but no worsening, or iSD, iPR, or iCR if those criteria are met 
compared to baseline).  As can be seen in Table F1, the prior documentation of iUPD does not 
preclude assigning iCR, iPR, or iSD in subsequent timepoint assessments or as best overall 
response providing that iCPD is not documented at the next assessment after iUPD. 
Source:  Seymour et al 2017. 

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APPENDIX G. COVID-19 PANDEMIC GUIDANCE 
Introduction 
The COVID-19 global pandemic, including peaks and troughs, presents challenges to the 
ongoing conduct of clinical trials.  In line with regulatory guidance regarding clinical study 
execution during the pandemic, the sponsor has standardized protocol considerations to ensure 
participant's safety is maintained and adequate benefit/risk analyses are applied relative to 
participation in the study, completion of study procedures, and objectives (EMA 2021). 
Recognizing the very dynamic nature of COVID-19 pandemic and flexibility required to manage 
the impact of the pandemic on ongoing clinical studies, clarifications specific to allowed 
ancillary local (country) medical tests, and/or additions may need to be added into respective 
study manuals and site-specific monitoring plans as applicable, with institutional and health 
authority requirements and approvals as warranted, and communicated and discussed with 
investigative sites as needed.  Relevant test results will be documented in the eCRF, and 
applicable changes to the ICF will be made and monitored. 
SARS-CoV-2 Infection and Participation in the Study 
Benefit/risk assessment in the context of the COVID-19 pandemic is provided in Section 2.2.5.1. 
Recommendations for COVID-19 Vaccination 
If performed during the study, the guidelines of SARS-CoV-2 vaccination, timing, and 
precautions are listed below: 
• Prophylactic vaccination with an approved vaccine against SARS-CoV-2 is not a 
study requirement (see Section 5.1).  Participants may complete the vaccination 
process during the study.  A "booster" vaccination dose if needed during the study is 
also acceptable.  
• If given, it is recommended that a vaccine is not administered on the day of study 
treatment or study drug infusion.  Administration of study treatment or study drug is 
recommended to be given at least 3 days later to ensure possible acute AEs due to the 
vaccine are managed and resolved or stable. 
• If given, the vaccination primary dose or doses, or boosters and manufacturer must be 
entered in the EDC system as a concomitant medication. 
• Since corticosteroids may be given for defined, relatively brief periods such as in the 
management of irAE toxicity, investigators may consider delaying the second dose of 
a vaccine against SARS-CoV-2 (if needed to be given during the study for example) 
until a corticosteroid regimen has been completed or the dose has been reduced to 
≤ 10 mg of prednisone equivalent. 
• Any AEs resulting from the vaccination and medications for treating the AEs must be 
entered in the eCRFs. 
• If a potential participant recovered from COVID-19 within approximately 6 months 
before signing the ICF, a negative test (PCR) may be performed. 

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Study Site Visits and Study Procedures 
If local travel restrictions, isolation requirements, or the investigator's benefit/risk assessment 
determines it to be unsafe for participants to attend study visits at the investigational site, the site 
staff may elect to pursue the following: 
• Predose laboratory procedures may be conducted ± 5 days before dosing (versus the 
± 3-day time window described in Section 8.7.6) and must be reviewed before dosing.  
During COVID-19 pandemic restrictions, when permissible as per national 
regulations*, safety labs may be conducted at hospitals near the participant's home, 
provided the data can be transferred to the study site and entered in the eCRFs, or at a 
relevant clinical facility authorized/certified (as legally required nationally) to 
perform such tests routinely, if this can be done within local restrictions on social 
distancing. 
− The sites should inform the sponsor about such arrangements. 
*Note:  This clarification (see also Section 6.6.1 and Section 8.1.6) is for countries, 
for example, Bulgaria, that do not allow visits at a clinic, local medical laboratory, or 
hospital outside of the approved study site for procedures and tests in the Protocol 
sections referenced above.  However, in Bulgaria, it is possible, if needed, to use the 
closest medical center or a medical laboratory for laboratory testing and ECGs.  
Procedures such as imaging and chest x-ray, for example, to supplement and monitor 
a COVID-19 diagnosis are not permissible at a local hospital outside the approved 
study site.  Applicable minor modifications to the ICF under the COVID-19 
subheading were consequently made to the Bulgarian ICF. Similar scenarios or 
information found or released for other countries will be managed outside the 
Protocol, including but not limited to changes to the study manual, by Dear 
Investigator Letter, and updates to ICFs. 
• In order to minimize a participant's risk, some study procedures such as a review of 
AEs and concomitant medications may be conducted via telemedicine modalities 
(phone or video) where appropriate or as per institutional guidelines during the 
COVID-19 pandemic.  Information reviewed must be available in the investigator's 
site binder and entered in the eCRFs.  On-site visits should be conducted whenever 
feasible and are required for administration of study drug/treatment. 
− The participant may also be asked to undergo additional safety laboratory 
assessments. 
• If study procedures are anticipated to be missed, then a potential participant should 
not be consented, as it is important to assess the safety and efficacy of the 
investigational study treatment. 
− In general, compliance with the Protocol should be ensured to such an extent that 
an ongoing benefit-risk assessment for the clinical trial and potential participants 
is still possible. 
• During COVID-19 pandemic restrictions only, scans for disease assessments may be 
delayed by an additional 7 days from the time allowed in the Protocol (see Table 3, 
Table 4, and Table 5 for details).  

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• If necessary, scans may be done at a different hospital only if the quality and 
methodology is the same as the participating study site and the images can be 
transferred properly to the study site.  It is the investigator's responsibility to confirm 
that the external facility meets these requirements before any scans are performed at 
that location. 
Note:  The sponsor has reviewed relevant guidance on the implications of COVID-19 on 
methodological aspects of ongoing clinical trials by the CHMP Biostatistics Working Party 
published on 25 MAR 2020 (EMA 2020). 
Study Drug and Study Treatment Administration 
If necessary, study treatment administration may be delayed up to 3 weeks due to COVID-19 
pandemic restrictions unless otherwise discussed with the sponsor.  The reason for interruption 
should be documented in the participant's medical records and eCRFs (eg, "due to COVID-19"). 
Chemotherapy and INCMGA00012/placebo cannot be administered at home. 
Study Treatment Management in the Event of SARS-CoV-2 Infection 
The following recommendations are necessary in the event of SARS-CoV-2 infection during the 
trial: 
• If a participant develops a SARS-CoV-2 infection, the event should be reported as an 
AE (or SAE if it meets the SAE definition requirements according to Section 9.2) and 
appropriate medical intervention should be provided. 
• Postbaseline SARS-CoV-2 testing should follow country-specific requirements 
depending on the extent of the COVID-19 pandemic, local institutional guidance, or 
investigator's clinical judgment. 
• For participants who are diagnosed with COVID-19 during the study (positive 
SARS-CoV-2 test) or presumed affected by SARS-CoV-2 infection (testing pending), 
study treatment should be delayed until the SARS-CoV-2 test is negative and the 
participant has clinically recovered from symptoms.  
− In addition, prior to restarting study treatment, the participant should be afebrile 
for 72 hours and SARS-CoV2-related symptoms (if any) should have recovered 
for a minimum of 72 hours. 
• Safety monitoring following COVID-19 should be implemented as per institutional 
guidance or clinical judgment (eg, coagulation factors).  
• Concomitant medication administered for the treatment of SARS-CoV-2 infection 
should be carefully considered for potential drug-drug interactions, and medications 
should be recorded in the eCRFs. 

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Clinical Study Monitoring 
Site monitoring guidelines and principles are listed below: 
• Study monitoring visits may be postponed; however, the site monitor and sponsor 
should continue to employ off-site monitoring practices such as routine 
communication methods (eg, phone calls, emails, video visits) with the sites to get 
information on study progress, participant status, and information on issue resolution.  
• The study monitor may remotely review data entered into the eCRFs for accuracy and 
completeness if allowed and first approved by the national regulatory body or 
investigational site and/or in compliance with local authorities (EMA 2021). 
− If remote source data verification focusing on quality control of critical data as 
per the monitoring plan or equivalent is not permitted, an investigational site will 
not be able to enroll new participants. 
Reimbursement of Additional Expenses 
If permitted by local or legal requirements, the sponsor may reimburse participants for any 
extraordinary expenses, keeping appropriate documentation as evidence (eg, travel expenses for 
the local laboratory visit[s], private transportation, the costs of local [proximate] laboratory 
tests). 

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APPENDIX H. PROTOCOL AMENDMENT SUMMARY OF CHANGES 
Document 
Date 
Amendment 1 
16 DEC 2021 
Amendment 2 
16 MAY 2022 
Amendment 3 
18 OCT 2022 
Amendment 3 (18 OCT 2022) 
Overall Rationale for the Amendment 
The primary purpose of the amendment is to align with the US FDA's recommendation that OS 
should be the only primary endpoint in the study and to update COVID-19 guidance in view of 
the evolving pandemic. Additional changes are summarized below. 
1. Section 1, Protocol Summary (Table 1:  Primary and Secondary Objectives and 
Endpoints; Table 2:  Key Study Design Elements); Section 2.2.2, Scientific Rationale 
for Study Design; Section 3, Objectives and Endpoints (Table 6:  Objectives and 
Endpoints); Section 4.1, Overall Design; Section 5.5, External Data Monitoring 
Committee; Section 10.1, Sample Size Determination; Section 10.2, Populations for 
Analysis (Table 17:  Populations for Analysis); Section 10.3, Level of Significance; 
Section 10.4.1, Primary Analysis; Section 10.4.1.1, Multiplicity Adjustment 
(Figure 2:  Multiplicity Graph for Type I Error Control); Section 10.4.3.1, 
Progression-Free Survival (Table 18:  Evaluation and Censoring of 
Progression-Free Survival); Section 10.5, Interim Analysis (Table 20:  Guidelines 
for Decisions in Overall Survival Endpoint) 
Description of change:  The dual primary objective of OS and PFS was changed to just 
OS.  Progression-free survival was converted to a secondary objective.  Consequently, for 
OS analysis, the same target of 341 OS events will provide 87% (from 85%) power to 
detect an HR of 0.7 at a 1-sided 2.5% (from 2.0%) significance level, and for PFS 
analysis, a target of 222 (from 314) PFS events will provide the same 90% power to 
detect an HR of 0.63 at a 1-sided 2.5% (from 0.5%) significance level. 
Rationale for change:  Based on a recommendation made by the US FDA due to 
2 considerations:  1) recent approvals granted by the FDA to first-line immunotherapy for 
metastatic lung cancer were based on statistically significant and formally tested 
improvements in OS and 2) due to the unclear impact on the analysis of PFS as a primary 
dual endpoint caused by disruptions in data collection and monitoring during the 
Ukrainian and Russian conflict. 

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2. Section 1, Protocol Summary (Table 3: Schedule of Activities for Participants With 
Nonsquamous Non–Small Cell Lung Cancer); Section 2.2.5.1, Benefit/Risk 
Assessment During the COVID-19 Pandemic; Section 5.1, Inclusion Criteria 
(Criterion 11); Section 8.1.6, COVID-19; Appendix G, COVID-19 Pandemic 
Guidance 
Description of change:  An updated reference was added demonstrating that 
immunotherapy does not negatively affect participants with cancer who are 
SARS-CoV-2–positive.  Participants' vaccination against SARS-CoV-2 was changed 
from mandatory to highly recommended.  Local and/or country guidelines as available 
are recommended to be followed for primary vaccination and/or boosters.  Potential 
participants are to be apprised with up-to-date information according to their country's 
vaccination program, local vaccination recommendations, or oncology societies' 
guidelines, as assessed by the investigator. 
Rationale for change:  To continue to provide a balanced view with current studies on a 
positive benefit/risk assessment during the COVID-19 pandemic or endemic or its 
variants, and to show cancer immunotherapy with immune checkpoint inhibitors such as 
the one provided in this study does not confer additional mortality risks in the setting of 
active COVID-19.  In view of the waxing and waning regional incidences of COVID-19, 
flexibility has been added to allow enrollment of participants who are not willing to 
receive vaccination and/or who have a contraindication to vaccination.  Additionally, the 
recommendation will provide flexibility for participant management in regions where 
COVID-19 is no longer endemic. 
3. Section 7.1.1, Reasons for Discontinuation; Section 7.3, Lost to Follow-Up; 
Section 8.12.3, Survival Follow-Up 
Description of change:  Before a participant is deemed lost to follow-up multiple (ie, at 
least 2) documented efforts must be made to regain contact unless participants have 
permanently withdrawn their consent for follow-up. 
Rationale for change:  Addition made since OS is the primary objective and to minimize 
loss to follow up. 
4. Section 10.2, Populations for Analysis (Table 17:  Populations for Analysis); 
Section 10.4.1, Primary Analysis 
Description of change:  The FAS description was reverted to the original population for 
analysis with the following removed:  For participants from Ukraine, all data will be 
censored by approximately 20 DEC 2021 due to potential concerns of not having critical 
data variables source verified. 
Rationale of change:  The primary analysis of a primary endpoint in a randomized study 
is based on the ITT principle as per regulatory guidelines; therefore, the originally 
defined FAS that includes all randomized participants is maintained. As per the FDA's 
recommendation to the sponsor, the potential impact due to the Ukrainian and Russian 
conflict (eg, wartime disruption) will be evaluated through sensitivity analyses as 
described in the SAP. 

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5. Appendix G, COVID-19 Pandemic Guidance 
Description of change:  Added note that visits at a clinic, local medical laboratory, or 
hospital outside of the approved study site for procedures and tests related to COVID-19 
are not permissible for the conduct of the study in Bulgaria.  Applicable minor 
modifications to the ICF under the COVID-19 subheading were consequently made. 
Rationale for change:  As per clarification that was requested by the Bulgarian Drug 
Agency on 22 MAR 2022.  
6. Incorporation of administrative changes.  Other regulatory guidance and 
administrative changes have been incorporated throughout the Protocol and are noted in 
the redline version of the amendment. 

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Amendment 2 (16 MAY 2022) 
Overall Rationale for the Amendment: 
The primary purpose of the amendment is to update the number of participants from 
approximately 530 to approximately 600.  Ukraine has randomized 160 participants in the study.  
Participants' care and study operations have been partially or completely disrupted in many 
Ukrainian cities, and the overall impact cannot be determined with any degree of certainty at this 
time.  The sponsor anticipates that many participants will be prematurely withdrawn or otherwise 
lost to follow-up prior to reaching the primary efficacy endpoints of PFS and OS, although an 
exact rate of attrition cannot be estimated from the available information.  Additional changes 
are summarized below. 
1. Sections 1, Protocol Summary (Table 2:  Key Study Design Elements); Section 4.1, 
Overall Design; Section 4.2, Number of Participants; Section 10.1, Sample Size 
Determination; Section 10.5, Interim Analysis 
Description of change:  An increase in study enrollment from approximately 
530 participants to approximately 600 participants. 
Rationale for change:  This increase in the number of participants does not change the 
number of target events for the PFS or OS endpoints in order to compensate for 
participants lost to follow-up or with less follow-up time than was anticipated due to 
conflict and national operational disruptions in Ukraine.  Further, this increase is to 
ensure study integrity and that the study will provide interpretable findings to support a 
marketing application. 
2. Section 4.3, Overall Study Duration 
Description of change:  Added that in EU/EEA, the results of the study will be based on 
the date of the last visit of the last participant in the study globally. 
Rationale for change:  As per recent EU Clinical Trial Regulation, it is required in the 
EU to post results within 1 year of study completion.  In this study, for analysis purposes, 
results will be posted after the last participant's last visit date has been reached globally 
(not just in EU).  This will ensure the results are robust, meaningful, and representative of 
all multiregions by having complete follow-up data determined by the statistical 
hypotheses for the objectives established. 
3. Section 10.1, Sample Size Determination; Section 10.4.1, Primary Analysis; 
Section 10.5 Interim Analysis 
Description of change:  Added high-level description of sensitivity analysis for dual 
primary efficacy endpoints of PFS and OS (due to potential early censoring from 
Ukrainian participants, approximately 600 participants will be enrolled to ensure enough 
number of events will be observed within reasonable follow-up time). 
Rationale for change:  Due to conflict and country organizational disruptions related 
issues in Ukraine, these changes are to ensure study integrity and to provide interpretable 
findings. 

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4. Section 10.2, Population for Analysis (Table 17:  Populations for Analysis) 
Description of change:  Updated definition of FAS to also include censored data for 
participants from Ukraine; all data will be censored by approximately 20 DEC 2021 due 
to potential concerns of not having critical data variables source-verified from that date 
forward. 
Rationale for change:  Due to conflict and country organizational disruptions related 
issues in Ukraine, these changes are to ensure study integrity and to provide interpretable 
findings. 
5. Section 10.4.2, Subgroup Analyses 
Description of change:  Updated subgroup categories for age and ethnic group and 
added subgroup analysis by country enrollment. 
Rationale for change:  Due to conflict and country organizational disruptions related 
issues in Ukraine, these changes are to ensure study integrity and to provide interpretable 
findings. 
6. Appendix G, COVID-19 Pandemic Guidance 
Description of change:  Corrected typographical error for type of a particular 
SARS-CoV-2 test and added that local (country) practices or regulations may dictate 
what may be able to be done at local hospitals outside the main investigational site as an 
ancillary diagnostic or supportive test, if needed, during the COVID-19 pandemic or 
regional resurges. 
Rationale for change:  Editorial and minor clarification.  Depending on the country, not 
all types of tests and/or procedures may be able or allowed to be performed at local 
hospitals, and proper planning is first warranted. 
7. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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Amendment 1 (16 DEC 2021) 
Overall Rationale for the Amendment: 
The primary purpose of Amendment 1 is to update the management of suspected irAEs, 
incorporate changes requested by regulatory authorities, and provide guidance for participant 
management during the COVID-19 pandemic. 
1. Section 1, Protocol Summary (Table 3:  Schedule of Activities for Participants With 
Nonsquamous Non-Small Cell Lung Cancer; Table 4:  Schedule of Activities for 
Participants With Squamous Non-Small Cell Lung Cancer); Section 8.3.3, Tumor 
Imaging During the Study 
Description of change:  Added a note that the first on-study image will be performed at 
6 weeks (± 7 days).  Clarification regarding the imaging schedule was also provided in 
Section 8.3.3. 
Rationale for change:  Clarification. 
2. Section 1, Protocol Summary (Table 3:  Schedule of Activities for Participants With 
Nonsquamous Non-Small Cell Lung Cancer); Section 5.1, Inclusion Criteria 
(Criterion 11); Section 6.6.1, Permitted Medications and Procedures; Section 8.1.6, 
COVID-19 
Description of change:  Inclusion criterion was added to indicate that potential 
participants with NSCLC are to be fully vaccinated against SARS-CoV-2 before 
randomization or willing and able to be fully vaccinated during the study by starting the 
vaccination process during screening.  SARS-CoV-2 vaccines and applicable ancillary 
procedures and tests were added to the list of permitted medications and procedures. 
Rationale for change:  Due to expanding protection for potential participants in a 
research study, and as per recommendations by the main international worldwide 
oncology societies (eg, ASCO, ESMO), this new requirement was added as a safety 
precaution. 
3. Section 1, Protocol Summary (Table 4:  Schedule of Activities for Participants With 
Squamous Non-Small Cell Lung Cancer) 
Description of change:  Added notes that Cycle 1 Day 8 and Cycle 1 Day 15 blood 
chemistries and hematology are applicable only to participants receiving nab-paclitaxel.  
Also, a note was added to indicate that the on-treatment pregnancy testing required at 
each cycle starts at Cycle 2 Day 1. 
Rationale for change:  Clarification. 
4. Section 1, Protocol Summary (Table 4: Schedule of Activities for Participants With 
Squamous Non-Small Cell Lung Cancer) 
Description of change:  Removed the Cycle 1 Day 8 timepoint for PK 
 
assessments. 
Rationale for change:  To correct a typographical error and align with the sample timing 
presented in Table 16. 

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5. Section 2.2.5.1, Benefit/Risk Assessment During the COVID-19 Pandemic; 
Appendix G, COVID-19 Pandemic Guidance 
Description of change:  New section was added to describe the sponsor's protocol 
considerations to ensure participant safety is maintained and adequate benefit/risk 
analyses are applied relative to participation in the study, completion of study procedures, 
and study objectives in the context of the global COVID-19 pandemic. 
Rationale for change:  To provide additional guidance to the investigators. This 
guidance is in line with regulatory guidance regarding clinical study execution during the 
pandemic. 
6. Section 4.3, Overall Study Duration 
Description of change:  Added clarification regarding treatment options for participants 
if the final analysis of OS is negative. 
Rationale for change:  Requested by the EU health authorities. 
7. Section 5.1, Inclusion Criteria (Criterion 4) 
Description of change:  A note was added to clarify that only participants without access 
to the best standard treatment options can be included in the study and may discontinue 
study treatment if those options become available.  This information was already fully 
described in the ICF. 
Rationale for change:  Requested by the EU health authorities. 
8. Section 5.2, Exclusion Criteria (Criterion 9); Section 8.1.6, COVID-19; Appendix D, 
Clinical Local Laboratory Tests 
Description of change:  A note was added to indicate that participants may be tested for 
COVID-19 if required by country or local regulations, and participants should be 
included only after they have a negative screening retest result for SARS-CoV-2 infection 
and no clinical symptoms. 
Rationale for change:  Part of dynamic COVID-19 safety, social, and community 
precautions. 
9. Section 5.2, Exclusion Criteria (Criterion 12) 
Description of change:  A note was added to specify that HIV testing is required in 
Czech Republic and South Africa. 
Rationale for change:  To reflect known local regulatory requirements. 
10. Section 5.2, Exclusion Criteria, (Criterion 13) 
Description of change:  The note was updated to indicate that the 3-year time 
requirement of no evidence of disease prior to study participation is not required for 
noninvasive or indolent malignancies. 
Rationale for change:  Clarification. 

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11. Section 6.1, Study Treatments Administered (Table 8: Study Drug and Treatment 
Information) 
Description of change:  Added powder for infusion under pemetrexed. 
Rationale for change:  To reflect both dose formulations available during the study. 
12. Section 6.1.1.1, INCMGA00012/Placebo 
Description of change:  Text was added to indicate that for the first 4 cycles, participants 
will be observed in the clinic for several hours after the infusion of 
INCMGA00012/placebo and chemotherapy administration. 
Rationale for change:  Requested by the EU health authorities. 
13. Section 6.3, Measures to Minimize Bias:  Randomization and Blinding 
Description of change:  An unblinded sponsor statistician will not be used to provide 
summary aggregated data by treatment group to the sponsor and/or the eDMC.  An 
external/independent statistician who is not part of the study team or the sponsor will be 
utilized. Details are described in the in the eDMC charter. 
Rationale for change:  Requested by the US FDA to avoid inadvertent unblinding of the 
study. 
14. Section 6.5.1, Dose Modifications for Immune-Related Toxicity (Table 9:  Dose 
Modifications for Adverse Events of INCMGA00012/Placebo and Toxicity 
Management Guidelines for Immune-Related Adverse Events) 
Description of change:  Guidance was updated for the management of diarrhea/colitis, 
hepatitis, endocrinopathies, skin, and all other irAEs. 
Rationale for change:  To align with updated information available for irAEs known to 
be associated with INCMGA00012 and other PD-1 inhibitors (eg, pembrolizumab, 
nivolumab). 
15. Section 6.5.1.1, Guidelines for Management of Suspected Infusion Reactions 
(Table 10:  Guidelines for Management of Suspected Infusion Reactions) 
Description of change:  The guidance for Grade 1 infusion reactions was revised to 
interrupt or slow the rate of infusion and to indicate when prophylaxis with an antipyretic 
and histamine blocker for subsequent cycles of INCMGA00012 or placebo 
administration are recommended.  Clarification was also provided on guidance for 
subsequent infusions after Grade 3 or 4 infusion reactions with rapid response to 
intervention. 
Rationale for change:  For clarification and to align with guidance based on the most 
recent information available for INCMGA00012 and other PD-1 inhibitors (eg, 
pembrolizumab, nivolumab) and with CTCAE v5.0. 
16. Section 8.1.2, Screening Procedures 
Description of change:  Wording regarding active HBV was clarified to match existing 
exclusion criteria. 
Rationale for change:  Clarification. 

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17. Section 8.7.6, Laboratory Assessments 
Description of change:  Information was added regarding tuberculosis testing and 
potentially delayed test results for amylase/lipase. 
Rationale for change:  Clarification requested by South Africa's health authority; and to 
provide guidance in a situation in which regional specific laboratory test results may be 
delayed as part of local standard. 
18. Section 9.4, Reporting of Serious Adverse Events 
Description of change:  Text, while known to investigators and site staff before the first 
participant was randomized, was added to clarify that SAE reporting is via EDC as the 
primary avenue.  Paper reporting is only when the EDC (ie, the clinical database) system 
may be temporarily down. 
Rationale for change:  Added for clarification only. 
19. Section 10.4.1.1, Multiplicity Adjustment (Figure 2:  Multiplicity Graph for Type I 
Error Control) 
Description of change:  Footnote was corrected to indicate ORR instead of OS. 
Rationale for change:  Typographical error; requested by the EU health authorities. 
20. Section 10.5, Interim Analysis (Table 20:  Guidelines for Decisions in Overall 
Survival Endpoint) 
Description of change:  The decision outcomes for the interim analysis were clarified to 
match existing text from overall section. 
Rationale for change:  Clarification requested by the EU health authorities. 
21. Appendix D, Clinical Local Laboratory Tests 
Description of change:  Amylase was added to the blood chemistry test panel to occur 
more frequently, and the footnote was clarified such that amylase, lipase, endocrine, and 
other specific laboratory tests may be performed more frequently for the management of 
irAE toxicities.  
Text was also added to indicate both HCV RNA and HCV antibody tests are required to 
determine eligibility as previously indicated in other sections, but for countries in which 
HCV RNA testing cannot be done per SOC, an HCV antibody test is acceptable.  
Rationale for change:  The addition of the amylase test was based on feedback by the 
EU health authorities.  Changes regarding HCV testing were for clarification only. 
22. Incorporation of administrative changes.  Other minor, administrative changes have 
been incorporated throughout the Protocol and are noted in the redline version of the 
amendment. 

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