A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell, Non-small-cell Lung
Sponsor: Merck Sharp & Dohme LLC

Official Protocol Title:
NCT number:
Document Date:
A Phase 3 Study of Pembrolizumab in Combination 
with Carboplatin/Taxane
(Paclitaxel or Nab-paclitaxel) Followed by 
Pembrolizumab with or without Maintenance 
Olaparib in the First-line Treatment of Metastatic 
Squamous Non-small Cell Lung
NCT03976362
31-JANUARY-2024

PRODUCT: MK-7339  
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Title Page
THIS PROTOCOL AMENDMENT AND ALL OF THE INFORMATION RELATING 
TO IT ARE CONFIDENTIAL AND PROPRIETARY PROPERTY OF MERCK 
SHARP & DOHME LLC, RAHWAY, NJ, USA (MSD).
Protocol Title: A Phase 3 Study of Pembrolizumab in Combination with 
Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or 
without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small 
Cell Lung Cancer (NSCLC)
Protocol Number: 008-07
Compound Number: MK-7339
Sponsor Name:
Merck Sharp & Dohme LLC
(hereafter referred to as the Sponsor or MSD)
Legal Registered Address:
126 East Lincoln Avenue
P.O. Box 2000
Rahway, NJ 07065 USA
Regulatory Agency Identifying Number(s):
IND
140819
Eudra CT 
2018-004721-88
Approval Date: 31 January 2024
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Sponsor Signatory
Typed Name:
Title:
Date
Protocol-specific Sponsor contact information can be found in the Investigator Study
File Binder (or equivalent).
Investigator Signatory
I agree to conduct this clinical study in accordance with the design outlined in this protocol 
and to abide by all provisions of this protocol.
Typed Name:
Title:
Date
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DOCUMENT HISTORY
Document
Date of Issue
Overall Rationale
Protocol Amendment 07
31-JAN-2024
Based on the data from an interim safety and efficacy analysis (IA3) for 
MK-7339-008 (data cutoff 21-SEP-2023), the external Data Monitoring Committee 
recommended to remove the final analysis. It was extremely unlikely that the 
efficacy boundary for success for the primary endpoint of OS would be reached by 
the final analysis. The study will remain open so ongoing participants will have 
continued access to Olaparib and pembrolizumab if they qualify per protocol or 
until transferred to an extension study, if applicable.
Protocol Amendment 06
09-SEP-2022
Merck Sharp & Dohme Corp. underwent an entity name and address change to 
Merck Sharp & Dohme LLC, Rahway, NJ, USA. This conversion resulted only in 
an entity name change and update to the address.
Protocol Amendment 05
18-FEB-2022
The protocol was amended to update the assumptions and timing of the analyses in 
the SAP to allow reasonable timing for PFS final analysis, and sufficient duration 
of follow-up based on updated enrollment period and the long-term survival data 
from the reference study KEYNOTE-407.
Protocol Amendment 04
22-OCT-2021
To update the dose modification and toxicity management guidelines for irAEs. To 
clarify that participants with PD after the first 4 cycles of induction will not enter 
the Maintenance Phase, but should enter the Safety Follow-up Visit.
Protocol Amendment 03
08-DEC-2020
To update the RECIST and iRECIST language to make the study intervention 
decision process following disease progression consistent throughout the protocol, 
and to update language to improve clarity and decrease redundancy throughout the 
protocol.
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Document
Date of Issue
Overall Rationale
Protocol Amendment 02
04-SEP-2019
To add weekly hematology sample collection during the Induction Phase for 
participants receiving nab-paclitaxel, further define Inclusion Criterion #5 to ensure 
adequate tissue collection prior to subject enrollment, change collection times of 
plasma and serum biomarkers, and clarify that if there is any new diagnosis of 
MDS or AML this should be reported throughout the Maintenance Phase including 
the Follow-up Phase.
Protocol Amendment 01
01-JUL-2019
To remove entry into long-term follow-up for participants who discontinue for any 
reason in the Induction Phase, provide clarity that long-term follow-up for disease 
status monitoring and overall survival will only be conducted for randomized 
participants, and to align the time of Long-term Follow-up visits with the imaging 
schedule.
Original Protocol
24-JAN-2019
Not Applicable
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PROTOCOL AMENDMENT SUMMARY OF CHANGES
Amendment: 07
Overall Rationale for the Amendment:
Based on the data from an interim safety and efficacy analysis (IA3) for MK-7339-008 (data 
cutoff 21-SEP-2023), the external Data Monitoring Committee recommended to remove the 
final analysis. It was extremely unlikely that the efficacy boundary for success for the 
primary endpoint of OS would be reached by the final analysis. The study will remain open 
so ongoing participants will have continued access to Olaparib and pembrolizumab if they 
qualify per protocol or until transferred to an extension study, if applicable.
Summary of Changes Table
Section Number and Name
Description of Change
Brief Rationale
Primary Reason for Amendment
Section 1.1, Synopsis: Duration of 
Participation
Added note regarding the study 
unblinding and the removal of the final 
analysis. Clarified that there will be no 
further analyses for efficacy and 
 
This change was made to address a 
strategy change as a result of the 
eDMC recommendation to remove the 
final analysis since the primary 
endpoint for OS would not be achieved 
by the final analysis. The rationale is 
further supported by new data from 
IA3 of a lack of additional clinical 
benefit on overall survival of the 
combination of pembrolizumab plus 
Olaparib.
Section Number and Name
Description of Change
Brief Rationale
Additional Changes
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Section Number and Name
Description of Change
Brief Rationale
Section 4.4, Beginning and End 
of Study Definition
Added a note that participants may be 
enrolled in a pembrolizumab extension 
study. 
Refer to Section 1.1 rationale
Section 6.1, Study Intervention(s) 
Administered
Added a note regarding that final 
analysis will not be performed. 
Refer to Section 1.1 rationale
Section 6.3.2, Stratification
Added a note that disease progression 
will no longer be centrally verified. 
Refer to Section 1.1 rationale
Section 6.3.3, Blinding
Added a note that participant treatment 
was unblinded. 
As part of the eDMC review of IA3 
data for futility, the participant 
treatment data were unblinded. 
Section 6.4.1, Olaparib 
Compliance
Added a note that participants should 
discontinue taking placebo.
Refer to Section 1.1 rationale
Section 6.5.1, Prohibited 
Concomitant Medications
Added a bullet that CYP3A4 inhibitors 
are only prohibited for participants 
taking Olaparib concomitantly
To clarify CYP3A inhibitors should not 
be taken with Olaparib.
Section 6.6, Dose Modification 
(Escalation/Titration/Other)
Added a note that unblinded participants 
should discontinue taking placebo and 
the course of action for potential 
participants undergoing the second 
course treatment.
Refer to Section 1.1 rationale
Section 7.1, Discontinuation of 
Study Intervention
Deleted the bullet for the criterion that 
treatment assignment has been unblinded
Refer to Section 6.3.3 rationale
Section 7.1, Discontinuation of 
Study Intervention
Removed centrally verified and added a 
note that disease progression will be 
assessed locally
Refer to Section 1.1 rationale
Section 8.1.8, Study Intervention 
Administration
Added a note that unblinded participants 
should discontinue taking placebo.
Refer to Section 1.1 rationale
Section 8.1.8.1, Timing of Dose 
Administration
Added a note that unblinded participants 
should discontinue taking placebo.
Refer to Section 1.1 rationale
Section 8.1.8.1.3, Olaparib or 
Olaparib Placebo
Added a note that unblinded participants 
should discontinue taking placebo.
Refer to Section 1.1 rationale
Section 8.1.9, Participant 
Blinding/Unblinding
Added a note that participant treatment 
was unblinded and the unblinding 
processes were no longer relevant.
Refer to Section 6.3.3 rationale
Section 8.2.1, Tumor Imaging and 
Assessment of Disease
Added a note that tumor response by 
BICR will not be collected. 
Refer to Section 1.1 rationale
Section 8.2.1.4, Second Course 
(Retreatment) Tumor Imaging
Deleted statement that central reading 
will be used to determine eligibility. 
Refer to Section 1.1 rationale
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Section Number and Name
Description of Change
Brief Rationale
Section 8.4.1, Time Period and 
Frequency for Collecting AE, 
SAE, and Other Reportable 
Safety Event Information
Added a note for AE assessments when 
participants roll over into an extension 
study
Clarify AE collection and reporting 
criteria during the transition to a 
pembrolizumab extension study
Section 8.12.5, Second Course 
Phase (Retreatment Period)
Added note that disease progression will 
be assessed locally and removed the
requirement for BICR determined 
progression. 
Refer to Section 1.1 rationale
Section 9, Statistical Analysis 
Plan
Added note describing the results of the
safety and efficacy IA that led to the
determination to stop the final analysis 
due to futility.
To describe the results of the IA3 and 
eDMC recommendations. To clarify the 
prespecified final analysis will not be 
performed and specify which analyses 
will be conducted as of Amendment 07.
Section 9, Statistical Analysis 
Plan
A statement was added that the 
prespecified final analysis of the study 
described in the SAP will not be 
performed.
Refer to Section 9 rationale regarding 
the IA3 and eDMC recommendation. 
Section 9.1, Statistical Analysis 
Plan Summary
A statement was added that the 
prespecified final analysis of the study 
described in the SAP will not be 
performed.
Refer to Section 9 rationale regarding 
the IA3 and eDMC recommendation. 
Section 9.7, Interim Analyses
A statement was added that the 
prespecified final analysis of the study 
described in the SAP will not be 
performed.
Refer to Section 9 rationale regarding 
the IA3 and eDMC recommendation. 
Section 9.8, Multiplicity
A statement was added that the 
prespecified final analysis of the study 
described in the SAP will not be 
performed.
Refer to Section 9 rationale regarding 
the IA3 and eDMC recommendation. 
Section 9.9, Sample Size and 
Power Calculations
A statement was added that the 
prespecified final analysis of the study 
described in the SAP will not be 
performed.
Refer to Section 9 rationale regarding 
the IA3 and eDMC recommendation. 
Throughout document
Minor typographical and/or editorial 
changes were made throughout.
To ensure clarity and consistency.
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Table of Contents
DOCUMENT HISTORY ........................................................................................................3
PROTOCOL AMENDMENT SUMMARY OF CHANGES...............................................5
1
PROTOCOL SUMMARY ............................................................................................17
1.1
Synopsis.................................................................................................................17
1.2
Schema ..................................................................................................................24
1.3
Schedule of Activities (SoA)................................................................................25
1.3.1
Screening and Induction Phases – ALL PARTICIPANTS .........................25
1.3.2
Maintenance Phase.......................................................................................32
1.3.3
End-of-Treatment and Long-term Follow-up ..............................................36
1.3.4
Second Course Treatment Phase..................................................................42
2
INTRODUCTION..........................................................................................................47
2.1
Study Rationale....................................................................................................47
2.2
Background ..........................................................................................................48
2.2.1
Olaparib........................................................................................................48
2.2.2
Pembrolizumab ............................................................................................49
2.2.3
Non-small Cell Lung Cancer (NSCLC).......................................................49
2.2.4
Current Treatment Options and Unmet Medical Need................................50
2.2.5
Pharmaceutical and Therapeutic Background .............................................51
2.2.5.1
Inhibition of PARP as a Target for Cancer Therapy..........................51
2.2.5.2
Inhibition of PD-1 as a Target for Cancer Therapy...........................52
2.2.5.3
Homologous Recombination Repair in Solid Tumors.......................53
2.2.6
Preclinical and Clinical Studies ...................................................................54
2.2.7
Ongoing Clinical Studies.............................................................................54
2.2.7.1
Information on Other Trial-related Therapy......................................54
2.3
Benefit/Risk Assessment......................................................................................54
3
HYPOTHESES, OBJECTIVES, AND ENDPOINTS................................................55
4
STUDY DESIGN............................................................................................................58
4.1
Overall Design......................................................................................................58
4.2
Scientific Rationale for Study Design.................................................................61
4.2.1
Rationale for Endpoints ...............................................................................63
4.2.1.1
Efficacy Endpoints.............................................................................63
4.2.1.1.1
RECIST 1.1..............................................................................63
4.2.1.1.2
iRECIST...................................................................................63
4.2.1.2
Safety Endpoints................................................................................64
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4.2.2
Rationale for the Use of Comparator/Placebo .............................................68
4.3
Justification for Dose...........................................................................................68
4.3.1
Starting Dose for Olaparib...........................................................................68
4.3.2
Starting Dose for Pembrolizumab................................................................68
4.3.2.1
Rationale for Carboplatin With Paclitaxel/nab-Paclitaxel Dosing 
Regimen.............................................................................................69
4.3.3
Maximum Dose/Exposure for This Study ...................................................69
4.3.3.1
Pembrolizumab ..................................................................................69
4.3.3.2
Olaparib..............................................................................................70
4.4
Beginning and End of Study Definition .............................................................70
4.4.1
Clinical Criteria for Early Study Termination .............................................70
5
STUDY POPULATION ................................................................................................70
5.1
Inclusion Criteria.................................................................................................70
5.2
Exclusion Criteria................................................................................................74
5.3
Lifestyle Considerations......................................................................................78
5.3.1
Meals and Dietary Restrictions....................................................................78
5.3.2
Contraception...............................................................................................78
5.3.3
Pregnancy.....................................................................................................78
5.3.4
Use in Nursing Women................................................................................78
5.3.5
Activity Restrictions ....................................................................................79
5.4
Screen Failures.....................................................................................................79
5.5
Participant Replacement Strategy......................................................................79
6
STUDY INTERVENTION............................................................................................79
6.1
Study Intervention(s) Administered...................................................................79
6.2
Preparation/Handling/Storage/Accountability .................................................81
6.2.1
Dose Preparation..........................................................................................81
6.2.2
Handling, Storage, and Accountability........................................................81
6.3
Measures to Minimize Bias: Randomization and Blinding..............................82
6.3.1
Intervention Assignment..............................................................................82
6.3.3
Blinding........................................................................................................83
6.4
Study Intervention Compliance..........................................................................83
6.4.1
Olaparib Compliance ...................................................................................83
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6.4.2
Pembrolizumab and Chemotherapy Compliance.........................................83
6.5
Concomitant Therapy..........................................................................................84
6.5.1
Prohibited Concomitant Medications ..........................................................84
6.5.2
Rescue Medications and Supportive Care ...................................................86
6.6
Dose Modification (Escalation/Titration/Other)...............................................87
6.6.1
Management of Overlapping Toxicities of Olaparib and Pembrolizumab..87
6.6.2
Olaparib Dose Modifications.......................................................................87
6.6.2.1
Management of Hematological Toxicities.........................................88
6.6.2.2
Management of Prolonged Hematological Toxicities .......................89
6.6.2.3
Management of Nonhematologic Toxicity........................................90
6.6.2.3.1
Management of New or Worsening Pulmonary Symptoms ....90
6.6.2.3.2
Management of Nausea and Vomiting ....................................90
6.6.2.3.3
Management of Renal Impairment ..........................................91
6.6.2.4
Interruptions for Intercurrent Non-toxicity-related Events................91
6.6.2.5
Dose Reductions for Concurrent CYP3A4 Inhibitor Use..................92
6.6.3
Immune-Related Events and Dose Modification (Withhold, Treat, 
Discontinue).................................................................................................92
6.6.4
Carboplatin and Paclitaxel or Nab-paclitaxel Dose Modification ...............97
6.7
Intervention After the End of the Study..........................................................101
6.8
Clinical Supplies Disclosure..............................................................................101
6.9
Standard Policies................................................................................................101
6.9.1
Study Site Retention Samples....................................................................102
7
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
WITHDRAWAL..........................................................................................................102
7.1
Discontinuation of Study Intervention.............................................................102
7.2
Participant Withdrawal From the Study.........................................................104
7.3
Lost to Follow-up ...............................................................................................104
8
STUDY ASSESSMENTS AND PROCEDURES......................................................104
8.1
Administrative and General Procedures .........................................................105
8.1.1
Informed Consent.......................................................................................105
8.1.1.1
General Informed Consent...............................................................105
8.1.1.2
Consent and Collection of Specimens for Future Biomedical 
Research...........................................................................................106
8.1.2
Inclusion/Exclusion Criteria ......................................................................106
8.1.3
Participant Identification Card...................................................................106
8.1.4
Medical History .........................................................................................106
8.1.4.1
Non-small Cell Lung Cancer History ..............................................107
8.1.5
Prior and Concomitant Medications Review.............................................107
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8.1.5.1
Prior Medications.............................................................................107
8.1.5.2
Concomitant Medications................................................................107
8.1.5.3
Subsequent Antineoplastic Therapy ................................................107
8.1.6
Assignment of Screening Number.............................................................107
8.1.7
Assignment of Treatment/Randomization Number...................................107
8.1.8
Study Intervention Administration ............................................................108
8.1.8.1
Timing of Dose Administration.......................................................108
8.1.8.1.1
Pembrolizumab ......................................................................109
8.1.8.1.2
Paclitaxel or Nab-paclitaxel...................................................109
8.1.8.1.2.1
Carboplatin...................................................................109
8.1.8.1.3
Olaparib or Olaparib Placebo.................................................110
8.1.8.1.4
Colony-stimulating Factors....................................................111
8.1.8.1.5
Antiemetic Therapy ...............................................................111
8.1.8.2
Discontinuation and Withdrawal .....................................................111
8.1.8.3
Withdrawal From Future Biomedical Research ..............................111
8.1.9
Participant Blinding/Unblinding................................................................112
8.1.10
Calibration of Equipment...........................................................................112
8.1.11
Tumor Tissue for Biomarker Status...........................................................113
8.2
Efficacy/Immunogenicity Assessments ............................................................113
8.2.1
Tumor Imaging and Assessment of Disease..............................................113
8.2.1.1
Initial Tumor Imaging......................................................................114
8.2.1.2
Tumor Imaging During the Study....................................................114
8.2.1.3
End-of-Treatment and Follow-up Tumor Imaging..........................115
8.2.1.4.1
Brain Imaging During Second Course...................................116
8.2.1.5
RECIST 1.1 Assessment of Disease................................................117
8.2.1.6
iRECIST Assessment of Disease.....................................................119
8.3
Safety Assessments.............................................................................................119
8.3.1
Physical Examinations...............................................................................120
8.3.2
Vital Signs..................................................................................................120
8.3.3
Electrocardiograms ....................................................................................120
8.3.4
Clinical Safety Laboratory Assessments ...................................................120
8.3.4.1
Bone Marrow or Blood Cytogenetic Samples .................................121
8.3.5
Performance Assessments..........................................................................121
8.3.5.1
Eastern Cooperative Oncology Group Performance Status.............121
8.4
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other 
Reportable Safety Events ..................................................................................121
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8.4.1
Time Period and Frequency for Collecting AE, SAE, and Other 
Reportable Safety Event Information ........................................................122
8.4.2
Method of Detecting AEs, SAEs, and Other Reportable Safety Events....124
8.4.3
Follow-up of AE, SAE, and Other Reportable Safety Event Information.124
8.4.4
Regulatory Reporting Requirements for SAE ...........................................124
8.4.5
Pregnancy and Exposure During Breastfeeding ........................................125
8.4.6
Disease-related Events and/or Disease-related Outcomes Not Qualifying 
as AEs or SAEs..........................................................................................125
8.4.7
Events of Clinical Interest (ECIs)..............................................................125
8.5
Treatment of Overdose......................................................................................126
8.6
Pharmacokinetics...............................................................................................126
8.7
Pharmacodynamics............................................................................................126
8.12
Visit Requirements.............................................................................................127
8.12.1
Screening....................................................................................................127
8.12.2
Pre-randomization Visit.............................................................................128
8.12.3
Treatment Period........................................................................................128
8.12.4
Participants Discontinued From Study Intervention but Continuing to be 
Monitored in the Study ..............................................................................128
8.12.5
Second Course Phase (Retreatment Period) ..............................................129
8.12.6
Posttreatment Visits ...................................................................................129
8.12.6.1
Safety Follow-up Visit.....................................................................129
8.12.6.2
Follow-up Visits...............................................................................129
8.12.6.3
Imaging Follow-up Visits ................................................................130
8.12.6.4
Survival Follow-up Assessments.....................................................130
8.12.7
Vital Status.................................................................................................130
9
STATISTICAL ANALYSIS PLAN ...........................................................................130
9.1
Statistical Analysis Plan Summary...................................................................131
9.2
Responsibility for Analyses/In-house Blinding ...............................................134
9.3
Hypotheses/Estimation ......................................................................................134
9.4
Analysis Endpoints.............................................................................................134
9.4.1
Efficacy Endpoints.....................................................................................134
9.4.2
Safety Endpoints........................................................................................135
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9.6
Statistical Methods.............................................................................................137
9.6.1
Statistical Methods for Efficacy Analyses.................................................137
9.6.1.1
Progression-free Survival.................................................................137
9.6.1.2
Overall Survival (OS) ......................................................................139
9.6.1.3
Analysis Strategy for Key Efficacy Endpoints................................139
9.6.2
Statistical Methods for Safety Analyses ....................................................140
9.6.3
Statistical Methods for PRO Analyses.......................................................142
9.6.4
Summaries of Baseline Characteristics, Demographics, and Other 
Analyses.....................................................................................................143
9.6.4.1
Demographic and Baseline Characteristics .....................................143
9.8
Multiplicity .........................................................................................................145
9.8.3
Safety Analyses..........................................................................................149
9.9
Sample Size and Power Calculations ...............................................................149
9.11
Compliance (Medication Adherence)...............................................................151
9.12
Extent of Exposure.............................................................................................151
10
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS...................................................................................................152
10.1
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations......152
10.1.1
Code of Conduct for Clinical Trials...........................................................152
10.1.2
Financial Disclosure...................................................................................154
10.1.3
Data Protection...........................................................................................154
10.1.3.1
Confidentiality of Data ....................................................................155
10.1.3.2
Confidentiality of Participant Records.............................................155
10.1.3.3
Confidentiality of IRB/IEC Information..........................................155
10.1.4
Committees Structure.................................................................................155
10.1.4.1
Executive Oversight Committee......................................................155
10.1.4.2
Data Monitoring Committee............................................................156
10.1.5
Publication Policy......................................................................................156
10.1.6
Compliance with Study Registration and Results Posting Requirements .156
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10.1.7
Compliance with Law, Audit, and Debarment ..........................................157
10.1.8
Data Quality Assurance .............................................................................157
10.1.9
Source Documents .....................................................................................158
10.1.10
Study and Site Closure...............................................................................159
10.2
Appendix 2: Clinical Laboratory Tests............................................................160
10.3
Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting.............................................................162
10.3.1
Definition of AE ........................................................................................162
10.3.2
Definition of SAE ......................................................................................163
10.3.3
Additional Events Reported in the Same Manner as SAE.........................164
10.3.4
Recording AE and SAE .............................................................................164
10.3.5
Reporting of AEs, SAEs, and Other Reportable Safety Events to the 
Sponsor ......................................................................................................168
10.4
Appendix 4: Device Events, Adverse Device Events, and Medical Device 
Incidents: Definitions, Collection, and Documentation..................................169
10.5
Appendix 5: Contraceptive Guidance and Pregnancy Testing......................170
10.5.1
Definitions..................................................................................................170
10.5.2
Contraception Requirements......................................................................171
10.5.3
Pregnancy Testing......................................................................................172
 
10.7
Appendix 7: Country-specific Requirements..................................................178
10.7.1
France-specific Requirements....................................................................178
10.7.2
Germany-specific Requirements................................................................178
10.7.3
Japan-specific Requirements .....................................................................179
10.7.4
United Kingdom-specific Requirements....................................................179
10.8
Appendix 8: Description of the iRECIST Process for Assessment of 
Disease Progression............................................................................................181
10.9
Appendix 9: Abbreviations ...............................................................................185
11
REFERENCES.............................................................................................................189
CCI
CCI
CCI
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LIST OF TABLES
Table 1
Summary of Study Interventions ..................................................................21
Table 2
Treatment Plan..............................................................................................59
Table 3
Adequate Organ Function Laboratory Values ..............................................72
Table 4
Study Interventions.......................................................................................80
Table 5
Management of Anemia................................................................................88
Table 6
Management of Neutropenia, Leukopenia, and Thrombocytopenia ............89
Table 7
Dose Reduction of Olaparib to Manage Moderate Renal Impairment .........91
Table 8
Dose Reduction of Olaparib with a Strong or Moderate CYP3A4 
Inhibitor.........................................................................................................92
Table 9
Dose Modification and Toxicity Management Guidelines for Immune-
related Adverse Events Associated with Pembrolizumab Monotherapy, 
Coformulations or IO Combinations ............................................................93
Table 10
Pembrolizumab Infusion Reaction Dose Modification and Treatment 
Guidelines .....................................................................................................96
Table 11
Dose Modification for Chemotherapeutic Agents ........................................99
Table 12
Recommended Chemotherapy Dose Modifications for Hematological 
Toxicity.......................................................................................................100
Table 13
Recommended Dose Modifications for Chemotherapy 
Nonhematological Toxicity ........................................................................101
Table 14
Reporting Time Periods and Time Frames for Adverse Events and Other 
Reportable Safety Events............................................................................123
Table 16
Analysis Strategy for Key Efficacy Variables............................................140
Table 17
Analysis Strategy for Safety Parameters.....................................................142
 
Table 21
Protocol-required Safety Laboratory Assessments.....................................160
Table 22
Highly Effective Contraception Methods...................................................172
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
CCI
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LIST OF FIGURES
Figure 1
Study Design Overview ................................................................................24
Figure 2
Study Intervention Decision-making Process When Progression per 
RECIST 1.1 is Observed by Investigator....................................................118
CCI
CCI
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1
PROTOCOL SUMMARY
1.1
Synopsis
Protocol Title: A Phase 3 Study of Pembrolizumab in Combination with 
Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab with or 
without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small 
Cell Lung Cancer (NSCLC)
Short Title: Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in 
First-line Metastatic Squamous NSCLC
Acronym: Not applicable
Hypotheses, Objectives, and Endpoints:
In male and female participants with Stage IV squamous non–small-cell lung cancer 
(NSCLC) with stable disease (SD), partial response (PR), or complete response (CR) 
following induction treatment with pembrolizumab combined with carboplatin and a taxane 
(paclitaxel or nab-paclitaxel):
Primary Objectives
Primary Endpoints
- Objective: To compare pembrolizumab plus 
maintenance olaparib with pembrolizumab 
plus placebo with respect to progression-free 
survival (PFS) assessed according to 
RECIST 1.1 (Section 4.2.1.1) by blinded 
independent central review (BICR).
- Hypothesis (H1): Pembrolizumab plus 
maintenance olaparib is superior to 
pembrolizumab plus placebo with respect to 
PFS per RECIST 1.1 (Section 4.2.1.1) by 
BICR.
- PFS, the time from the date of 
randomization until either documented 
disease progression or death due to any 
cause, whichever occurs first.
- Objective: To compare pembrolizumab plus 
maintenance olaparib with pembrolizumab 
plus placebo with respect to overall survival 
(OS).
- Hypothesis (H2): Pembrolizumab plus 
maintenance olaparib is superior to 
pembrolizumab plus placebo with respect to 
OS.
- OS, the time from the date of 
randomization to death due to any cause.
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Secondary Objectives
Secondary Endpoints
- Objective: To evaluate the safety and 
tolerability of pembrolizumab plus 
maintenance olaparib compared to 
pembrolizumab plus placebo.
- Adverse events (AEs)
- Discontinuation of study intervention due 
to AEs
- Objective: To evaluate the change from 
baseline (at randomization) and the time to 
true deterioration (TTD) in global health 
status/quality of life (QoL), cough, chest 
pain, dyspnea and physical functioning 
following treatment with pembrolizumab 
plus maintenance olaparib compared to 
pembrolizumab plus placebo.
- Change from baseline (at randomization) 
and the time to true deterioration (TTD)
defined as the time from baseline (at 
randomization) to the first onset of a ≥10-
point deterioration with confirmation by 
the subsequent visit of a ≥10-point 
deterioration in the following European 
Organization for Research and Treatment 
of Cancer Quality of Life Questionnaire 
(EORTC QLQ) and QLQ Lung Cancer 
Module 13 (LC13) scales/items:
- Global health status/QoL (C30/Items 29 
and 30)
- Cough (LC13/Item 1)
- Chest pain (LC13/Item 10)
- Dyspnea (C30/Item 8)
- Physical functioning (C30/Items 1 – 5)
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Overall Design:
Study Phase
Phase 3
Primary Purpose
Treatment
Indication
Treatment with pembrolizumab and maintenance olaparib 
in participants with stable disease, PR or CR upon 
completion of 4 cycles of induction pembrolizumab with 
carboplatin/taxane chemotherapy in participants with 
Stage IV squamous NSCLC in need of first-line therapy
Population
Adult participants with treatment-naïve Stage IV 
squamous NSCLC
Study Type
Interventional
Intervention Model
Parallel
This is a multisite study.
Type of Control
Placebo control
Study Blinding
Double-blind with In-House Blinding Procedures
Masking
Participant or Subject
Investigator
Sponsor
Estimated Duration of Study
The Sponsor estimates that the study will require 
approximately 60 months from the time the first 
participant (or their legally acceptable representative) 
provides documented informed consent until the last 
participant’s last study-related contact.
Number of Participants:
Approximately 857 participants will be enrolled into an Induction Phase, with approximately 
590 required for randomization, as described in Section 9.9.
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Intervention Groups and Duration:
Intervention 
Groups
Induction Phase (4 Cycles)
All participants will receive the study intervention (pembrolizumab + 
carboplatin/taxane-based chemotherapy) in a nonrandomized Induction 
Phase:
•
Pembrolizumab 200 mg IV every 3 weeks (Q3W) on Day 1 
(Cycles 1-4)
•
Carboplatin titrated to an area under the plasma drug concentration-
time curve (AUC) of 6 mg/mL/min IV Q3W on Day 1 (Cycles 1-4)
•
Taxane, investigator’s choice (paclitaxel or nab-paclitaxel)
Paclitaxel 200 mg/m2 Q3W on Day 1 (Cycles 1-4)
           OR
Nab-paclitaxel 100 mg/m2 (D1, D8, D15) Q3W for (Cycles 1-4)
Maintenance Phase (Up to 31 Cycles of Pembrolizumab):
Participants with a partial or complete disease response or with stable 
disease who meet eligibility criteria after the fourth cycle of the Induction 
Phase will be randomly assigned to pembrolizumab + maintenance 
olaparib or pembrolizumab + matching maintenance olaparib placebo (P)
(see study schema in Figure 1). 
•
Pembrolizumab 200 mg IV Q3W for a maximum of 31 cycles or until 
specific discontinuation criteria are met (Section 7.1)
•
Olaparib 300 mg twice daily (BID) will continue until specific 
discontinuation criteria are met (Section 7.1). 
•
Olaparib placebo BID will continue until specific discontinuation 
criteria are met (Section 7.1).
Note: Eligible participants who enter the Maintenance Phase may 
receive a maximum of 35 cycles of pembrolizumab during the study 
(4 cycles during the Induction Phase and 31 cycles during the 
Maintenance Phase). If pembrolizumab is stopped due to toxicity or 
completion of 31 cycles during the Maintenance Phase, the 
participant may continue with olaparib/olaparib placebo until 
specific discontinuation criteria are met (Section 7.1). If 
olaparib/olaparib placebo is stopped due to toxicity, the participant 
may continue to receive pembrolizumab for a maximum of 31 cycles 
during the Maintenance Phase or until specific discontinuation 
criteria are met (Section 7.1).
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Note: Consultation with the Sponsor is required if a participant 
receives fewer than 4 cycles of study intervention during the 
Induction Phase without progressive disease, and the investigator 
would like to randomize the participant to the Maintenance Phase.
Note: The study has been unblinded as of 15-DEC-2023. 
Participants who are confirmed to be actively taking placebo should 
discontinue taking the placebo intervention and continue in the 
study.
End-of-Treatment and Long-term Follow-up
After the End-of-Treatment (EOT) visit, those randomized participants 
who discontinue for reasons other than radiographic progressive disease 
will have long-term follow-up for disease status (every 6 weeks up to 48 
weeks post-randomization and, thereafter, every 9 weeks) until 
experiencing progressive disease, initiating a non-study cancer treatment, 
withdrawal of consent, becoming lost to follow-up, or end of study 
(EOS). All participants will be followed by telephone for OS every 3 
months, until death, withdrawal of consent, or EOS.
A summary of the study interventions, including dose formulation, dose
strength, dose frequency, route of administration, treatment period, and 
use is presented in Table 1.
Table 1
Summary of Study Interventions
Drug Name
Dose 
Formulation
Dose 
Strength
Dose 
Frequency
Route 
of 
Admin.
Treatment 
Period
Use
Olaparib
Tablet
300 mg
BID
Oral
Maintenance 
Phase
Experimental
Olaparib 
placebo
Tablet
N/A
BID
Oral
Maintenance 
Phase
Experimental
Pembrolizumab
Solution for 
infusion
200 mg
Q3W
IV
Induction 
and 
Maintenance 
Phases
Experimental
Paclitaxel
Solution for 
infusion
200 mg/m2
Q3W
IV
Induction 
Phase
SOC
Nab-paclitaxel
Solution for 
infusion
100 mg/m2
Q3W
IV
Induction 
Phase
SOC
Carboplatin
Solution for 
infusion
AUC 
6 mg/mL/min
Q3W
IV
Induction 
Phase
SOC
Abbreviations: AUC=area under the plasma drug concentration-time curve; BID=twice daily; 
IV=intravenous; N/A=not applicable; Q3W=every 3 weeks; SOC=standard of care.
Total Number
2 arms
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Duration of 
Participation
Each participant will participate in the study from the time the participant 
provides documented informed consent through the final protocol-
specified contact.
Induction Phase:
After a Screening Phase, each participant will enter into the 
nonrandomized Induction Phase and will receive 4 cycles of assigned 
study intervention for approximately 3 months:  pembrolizumab in 
combination with carboplatin and either paclitaxel or nab-paclitaxel. 
Maintenance Phase: 
Only participants who have received 4 cycles of study treatment during 
the Induction Phase, have at least one evaluable imaging timepoint during 
the Induction Phase, have no imaging visit with an overall response of PD 
(as verified by BICR, are clinically stable, and meet eligibility criteria to 
participate in the Maintenance Phase will be randomized to receive either 
pembrolizumab plus olaparib or pembrolizumab plus placebo. 
Participants will receive randomly assigned study intervention during the 
Maintenance Phase until disease progression is radiographically 
documented per RECIST 1.1 (verified by BICR) and, when clinically 
appropriate, confirmed by the site per modified Response Evaluation 
Criteria in Solid Tumors 1.1 for immune-based therapeutics (iRECIST), 
unacceptable AEs, intercurrent illness that prevents further administration 
of treatment, investigator’s decision to discontinue the participant, 
noncompliance with study intervention or procedure requirements or 
administrative reasons requiring cessation of treatment. Eligible 
participants who enter the Maintenance Phase may receive a maximum of 
35 cycles of pembrolizumab during the study (4 cycles during the 
Induction Phase and 31 cycles during the Maintenance Phase). If 
pembrolizumab is stopped due to toxicity or completion of 31 cycles, the 
participant may continue with maintenance olaparib until specific 
discontinuation criteria are met (Section 7.1). If maintenance olaparib is 
stopped due to toxicity, the participant may continue to receive 
pembrolizumab for a maximum of 31 cycles during the Maintenance 
Phase or until specific discontinuation criteria are met (Section 7.1).
End-of-Treatment and Long-term Follow-up:
After the EOT visit, each participant will be followed for the occurrence 
of AEs and spontaneously reported pregnancy as described under Section 
8.4.  
Randomized participants who discontinue for reasons other than 
radiographic disease progression will have long-term follow-up imaging 
for disease status until disease progression is documented 
radiographically per RECIST 1.1, initiating a non-study cancer treatment, 
withdrawal of consent, becoming lost to follow up, or EOS. All 
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randomized participants will be followed by telephone every 3 months 
for overall survival until death, withdrawal of consent, or the end of the 
study.
Randomized participants are expected to participate in the study for 
approximately 60 months including the Long-term Follow-up Phase.
Second Course Phase
Participants in each arm who stop study intervention after receiving 35 
cycles of pembrolizumab for reasons other than disease progression or 
intolerability, may be eligible for up to an additional 1 year (17 cycles) of 
pembrolizumab after experiencing disease progression (Second Course 
Phase; Section 8.12.5).
Note: Based on the data from an interim safety and efficacy analysis 
(IA3), the external Data Monitoring Committee recommended to remove
the Final Analysis. All study participants still receiving study treatment 
will be informed of the analysis and should continue to receive therapy 
on study and undergo modified protocol study procedures as specified in 
Amendment 07. There were no new safety signals identified in the IA3 
analysis. Participants who are confirmed to be actively taking placebo 
should discontinue taking the placebo intervention and continue in the 
study. Participants currently on study treatment with Olaparib may 
continue treatment per Investigator's discretion after discussion with their 
physician. Participants who are potential candidates for Second Course 
treatment will continue in Efficacy Follow-up. Participants currently 
undergoing or who will undergo Second Course treatment with 
pembrolizumab monotherapy can continue or start treatment per 
Investigator’s discretion under this protocol or under an extension study.
Study Governance Committees:
Executive Oversight Committee
Yes
Data Monitoring Committee
Yes
Clinical Adjudication Committee
No
Study governance considerations are outlined in Appendix 1.
Study Accepts Healthy Volunteers: No
A list of abbreviations used in this document can be found in Appendix 9.
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1.2
Schema
The study design (Screening, Induction Phase, and Maintenance Phase) is depicted in Figure 1.
Figure 1
Study Design Overview
Abbreviations: ECOG=Eastern Cooperative Oncology group; NSCLC=non-small cell lung cancer; 
PD=progressive disease; SD/PR/CR=stable disease/partial response/complete response.
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1.3
Schedule of Activities (SoA)
1.3.1
Screening and Induction Phases – ALL PARTICIPANTS
Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Administrative Procedures
Informed Consent
X
Consent must be obtained prior to 
performing any protocol-specific 
procedures. 
FBR ICF (optional)
X
Participants can still participate in 
the study if they decline to sign the 
Future Biomedical Research ICF.
Inclusion/Exclusion Criteria
X
Participant Identification 
Card
X
X
At the time of Visit Number 2/Cycle 
1, Day 1, site personnel should add 
the screening number to the 
Participant ID card.
Demographics and Medical 
History
X
History of blood 
transfusions
X
Include history of blood transfusion 
within previous 120 days from start 
of study intervention and the 
reasons, eg, bleeding or 
myelosuppression
Prior/Concomitant 
Medication Review
X
-------------------------------------------------------------------------------------------------
Include blood transfusions during 
review of concomitant medications
NSCLC Disease Details
X
Obtain Study Treatment 
Assignment using IRT
X
Cycle 1, Day 1 study intervention 
must be administered within 3 days 
of enrolling the participant in the 
study.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Administration of Study Intervention
Pembrolizumab
X
X
X
X
200 mg Q3W for a maximum of 4 
cycles
Carboplatin 
X
X
X
X
AUC 6 mg/mL/min Q3W
Paclitaxel
X
X
X
X
200 mg/m2 Q3W
Nab-paclitaxelb
X
X
X
X
X
X
X
X
X
X
X
X
100 mg/m2 on Days 1, 8, and 15 of 
Cycles 1-4. Day 8 and 15 window ±
1 day.
Tumor Tissue Collection
Archival or Newly Obtained
Tissue Collection for PD-L1 
IHC and other Biomarkers
X
A new incisional or core biopsy will 
be required if archival tissue is not 
available. PD-L1 IHC will be 
mandatory to stratify participants 
prior to randomization for the 
Maintenance Phase.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Efficacy Proceduresc
CT/MRI imaging of chest, 
abdomen, and pelvis
X
X
Xd
The first on study imaging visit has a 
window of +7 days. All other 
imaging visits have a visit window 
of ±7 days.
Screening images are to be captured 
within 28 days of first dose.
During the Induction Phase, images 
will be captured every Q6W from 
the date of the first dose (Cycle 1).
Imaging timing should follow 
calendar days and should not be 
adjusted for delays in study 
intervention.
All imaging must be submitted to 
central imaging vendor as soon as 
possible for expedited central review 
to determine eligibility for
randomization into Maintenance 
Phase
MRI of Brain
X
X
X
Participants with treated brain 
lesions and participants with known, 
asymptomatic, untreated brain 
lesions at diagnosis may participate,
but require regular imaging of the 
brain as a site of disease. 
Participants without brain lesions at 
baseline should be imaged as 
clinically indicated.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Safety Procedures
AE Monitoring
X
--------------------------------------------------------------------------------------------------
AEs: Report all AEs occurring from 
the start of study treatment through 
30 days following the last dose of 
study intervention.
SAEs: Report all SAEs from the 
start of study intervention through 
90 days following the last dose of 
study intervention, or 30 days 
following the last dose of study 
intervention if the participant 
initiates new anticancer therapy, 
whichever is earlier.
New diagnoses of MDS and AML 
should be reported throughout the 
study, including the follow-up 
period.
Complete Physical 
Examination (including 
height)
X
Height at screening only
Directed Physical 
Examination
X
X
X
X
Directed physical exam performed 
as clinically indicated prior to 
treatment administration.
Weight
X
X
X
X
X
Vital Signs 
(HR, DBP, SBP, RR, 
temperature)
X
X
X
X
X
X
X
X
X
X
X
X
X
Assessments performed prior to 
treatment administration. The Day 8 
and Day 15 evaluations apply only 
to nab-paclitaxel.
12-lead ECG
X
12-lead ECG performed using local 
standard procedures. Additional 
ECGs performed as clinically 
indicated.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Hematology
X
X
Xb
Xb
X
Xb
Xb
X
Xb
Xb
X
Xb
Xb
Screening samples to be collected 
within 10 days prior to first dose of 
treatment intervention.
On-treatment samples to be
collected within 72 hours prior to the 
first dose of study intervention in 
each cycle.
Urinalysis
X
Chemistry
X
X
X
X
X
Thyroid Function Tests 
(total T3 or free T3, FT4, 
TSH)
X
X
Cycle 1, Day 1 tests may be 
performed within 10 days prior to 
first dose of study intervention. On-
treatment tests performed every 
other cycle. 
Participants may be dosed while 
thyroid function tests are pending.
HBV, HCV, and HIV 
testing
X
HBV and HCV screening tests are 
not required unless participant has a 
known history of infection or as 
mandated by local health authority.
No HIV testing is required unless 
mandated by local health authority. 
Refer to Appendix 7 for country-
specific requirements.
Urine Pregnancy Test 
(WOCBP only)
X
WOCBP require a negative highly 
sensitive urine test within 24 hours
(72 hours for serum) prior to the first 
dose of study intervention.
Testing during the Induction Phase 
must be conducted as clinically 
indicated and as per local regulations 
where applicable. Serum test is only 
required if urine test is positive or is 
not evaluable.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
PT or INR and aPTT
X
Screening samples collected within 
10 days of treatment initiation.
PT or INR and aPTT should be 
monitored more closely in 
participants receiving anticoagulant 
therapy during treatment and Safety 
Follow-up Period.
Creatinine clearance 
calculation
X
X
X
X
X
Creatinine Clearance is calculated 
using the Cockcroft-Gault method 
(Table 3).
ECOG performance status
X
X
X
X
X
Screening assessment to be 
performed within 7 days prior to 
administration of study intervention.
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Study Period
Screening
Phase
Induction Phase (3 –Week Cycles)a
Notes
Cycle
1
2
3
4
Day (in Cycle)
1
8
15
1
8
15
1
8
15
1
8
15
Visit Number/Title
1
2
3
4
5
6
7
8
9
10
11
12
13
Scheduling Window 
(Days):
-28 to -1
+3
-
-
±3
-
-
±3
-
-
±3
-
-
Abbreviations:  AE = adverse event; aPTT = activated partial thromboplastin time; 
 DBP = diastolic blood pressure; DC = discontinuation; 
ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; FBR = Future Biomedical Research; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = 
human immunodeficiency virus; HR = heart rate; ICF = informed consent form; ID = identification; IHC = immunohistochemistry; INR = International Normalized Ratio; IRT 
= interactive response system; PD = progressive disease; PD-L1 = programmed death ligand 1; PRO = patient-reported outcome; PT = prothrombin time; Q3W = every 
3 weeks; Q6W = every 6 weeks; RR = respiratory rate; SBP = systolic blood pressure; TSH = thyroid-stimulating hormone; WOCBP = women of childbearing potential.
a.
Participants who do not continue to the randomization phase are to complete the 30-day safety follow-up assessments; refer to Section 1.3.3.
b.
Day 8 and 15 only apply if Nab-paclitaxel is given instead of paclitaxel. Days 8 and 15 are based on Day 1 of each cycle.
c.
Imaging should continue to be performed until PD is verified, the start of new anticancer treatment, withdrawal of consent, pregnancy, or death, whichever occurs first.
d.
Imaging must occur at Week 12. Imaging should be performed within 28 days of entering the Maintenance Phase.
CCI
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1.3.2
Maintenance Phase
Study Period
Post-induction/Pre-
randomization Visita
Maintenance Phaseb
(3–Week Cycles)
Notes
As of Amendment 07, tumor imaging will be assessed locally based on 
the site’s standard of care imaging schedule. Also, participants who are 
still on study treatment will no longer require ePRO assessments.
Cycle
-
1+
Day (in Cycle)
-
1
Visit Number/Title
14
15+
Scheduling Window (Days):
±3
±3
Administrative Procedures
Maintenance Phase Checklist
X
Pre-randomization visit is to occur 4 weeks ± 7 days from Cycle 4, Day 
1 of induction. 
Checklist must be reviewed by Sponsor. Participants with PD must be 
excluded from the Maintenance Phase and should enter the Safety 
Follow-up Visit (refer to Section 1.3.3).
Inclusion/exclusion criteria
X
Prior/Concomitant Medication Review
X
X
Include blood transfusions during review of concomitant medication.
Randomization
X
Study drug administration should begin on the day of randomization, 
but no later than 3 days after randomization. At this time, the participant 
will receive an allocation number.
Administration of Study Intervention
Olaparib
X
To initiate maintenance olaparib, creatinine clearance (CrCl) must be 
≥51 mL/min.
Continuous daily dose of 300 mg BID until progression of disease, 
intolerable toxicities, or physician decision.
Maintenance olaparib to start at least 4 weeks and no later than 6 weeks 
from Cycle 4, Day 1 of study medication in the Induction Phase.
Participants will self-administer olaparib except on Day 1 of first cycle, 
when the dose will be given at the study site clinic prior to the infusion 
of pembrolizumab.
Pembrolizumab
X
Participants will need to return to the site Q3W for dosing at 200 mg for 
a maximum of 31 cycles or until progression of disease, intolerable 
toxicities, or physician decision.
Pembrolizumab to restart at least 4 weeks and no later than 6 weeks 
from Cycle 4, Day 1 of study medication in the Induction Phase.
Olaparib or Olaparib Placebo Container Returned
X
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Study Period
Post-induction/Pre-
randomization Visita
Maintenance Phaseb
(3–Week Cycles)
Notes
As of Amendment 07, tumor imaging will be assessed locally based on 
the site’s standard of care imaging schedule. Also, participants who are 
still on study treatment will no longer require ePRO assessments.
Cycle
-
1+
Day (in Cycle)
-
1
Visit Number/Title
14
15+
Scheduling Window (Days):
±3
±3
Efficacy Procedures
Imaging should continue to be performed until PD is verified, the start 
of new anticancer treatment, withdrawal of consent, pregnancy, or 
death, whichever occurs first. Imaging can continue to be performed 
after PD is verified if the investigator elects to continue treatment and 
follow iRECIST. See Section 8.2.1.5.
CT/MRI imaging of chest, abdomen, and pelvis
X
The first imaging visit has a visit window of +7 days, all subsequent 
imaging visits have a visit window of ±7 days.
During the Maintenance Phase, images will be captured Q6W for the 
first 48 weeks from the date of randomization, followed by Q9W 
thereafter until disease progression, or the start of new anticancer 
treatment.
A new baseline CT scan of the chest/abdomen/pelvis will be needed 
prior to initiating Cycle 1 of the Maintenance Phase if the last imaging 
was obtained >28 days before the date of randomization.
Imaging timing should follow calendar days and should not be adjusted 
for delays in study intervention.
Note: As of Amendment 07, tumor imaging will be assessed locally 
based on the site’s standard of care schedule. 
MRI of Brainc
X
Safety Procedures
AE Monitoring
X
X
AEs: Report all AEs occurring from the start of study intervention 
through 30 days following the last dose of study intervention.
SAEs: Report all SAEs occurring from the start of study intervention 
through 90 days following the last dose of study invention, or 30 days 
following the last dose of study intervention if the participant initiates 
new anticancer therapy, whichever is earlier.
New diagnoses of MDS and AML should be reported throughout the 
study, including the follow-up period.
Directed Physical Examination
X
X
Directed physical exam performed as clinically indicated prior to 
treatment administration.
Weight
X
X
Vital Signs 
(HR, DBP, SBP, RR, temperature)
X
X
Assessments performed prior to treatment administration.
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Study Period
Post-induction/Pre-
randomization Visita
Maintenance Phaseb
(3–Week Cycles)
Notes
As of Amendment 07, tumor imaging will be assessed locally based on 
the site’s standard of care imaging schedule. Also, participants who are 
still on study treatment will no longer require ePRO assessments.
Cycle
-
1+
Day (in Cycle)
-
1
Visit Number/Title
14
15+
Scheduling Window (Days):
±3
±3
Hematology
X
X
Laboratory tests performed within 3 days of Cycle 1 (ie, pre-
randomization) do not need to be repeated at Cycle 1. 
On-treatment samples collected prior to administration of study 
intervention.
Thyroid function tests at Cycle 1 followed by every other cycle through 
Cycle 31.
Participants may be dosed while thyroid function tests are pending.
Chemistry
X
X
Thyroid Function Tests
Total or Free T3
FT4
TSH
X
Urine Pregnancy Test 
(WOCBP only)
X
X
WOCBP require a negative highly sensitive urine test at the pre-
randomization visit and within 24 hours (72 hours for serum) prior to 
first dose of study intervention. Serum test only required if urine test is 
positive or not evaluable. Testing during Maintenance Phase must be 
conducted as clinically indicated and as per local regulations, where 
applicable. More frequent pregnancy testing may be indicated, as 
dictated by local regulations.
Creatinine clearance calculation
X
X
CrCl is calculated using the Cockcroft-Gault method (Table 3). As an 
alternative, CrCl can be determined from a 24-hour urine collection. To 
initiate maintenance olaparib, CrCl must be ≥51 mL/min.
ECOG performance status
X
X
ECOG performance status will be evaluated within 7 days of the first 
administration of study intervention and before administration of each 
cycle.
Patient-Reported Outcomes
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Study Period
Post-induction/Pre-
randomization Visita
Maintenance Phaseb
(3–Week Cycles)
Cycle
-
1+
Day (in Cycle)
-
1
Visit Number/Title
14
15+
Scheduling Window (Days):
±3
±3
Abbreviations:  AE = adverse event; BID = twice daily; CrCl = creatinine clearance; ctDNA = circulating tumor DNA; DBP = diastolic blood pressure; DC = discontinuation; 
ECOG = Eastern Cooperative Oncology Group; 
 HR = heart rate; ICF = informed consent form; PD = progressive disease; PRO = patient-reported outcome; Q3W = every 3 weeks; Q6W = every 6
weeks; Q9W = every 9 weeks; RR = respiratory rate; SBP = systolic blood pressure; SoA = schedule of activities; WOCBP = women of childbearing potential.
a.
Participants who do not qualify for the Maintenance Phase will proceed to the 30-day Safety Follow-up (refer to Section 1.3.3).
b.
Study drug administration should begin on the day of randomization, but no later than 3 days after randomization.
c.
Participants with treated brain lesions and participants with known, asymptomatic, untreated brain lesions at diagnosis will require regular imaging of the brain during the 
Maintenance Phase as a site of disease. Participants without brain lesions at baseline should be imaged as clinically indicated.
CCI
CCI
CCI
CCI
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1.3.3
End-of-Treatment and Long-term Follow-up 
Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
Administrative Procedures
Prior/Concomitant Medication 
Review
X
X
X
X
Include blood transfusions during review 
of concomitant medication
Survival status
----------------------------------------------------------------------
Continued after verified PD or start of 
new anticancer treatment. In addition, 
upon Sponsor request, participants may be 
contacted for survival status at any time 
during the course of the study
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Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
Efficacy Procedures
Imaging should continue to be performed 
until PD is verified, the start of new 
anticancer treatment, withdrawal of 
consent, pregnancy, or death, whichever 
occurs first.
CT/MRI imaging of chest, abdomen, 
and pelvis
Xd
X
All imaging visits have a visit window of 
±7 days. Imaging will be captured Q6W 
for the first 48 weeks from the date of 
randomization, followed by Q9W 
thereafter until verified disease 
progression, or the start of new anticancer 
treatment. Imaging timing should follow 
calendar days and should not be adjusted 
for delays in study intervention.
As of Amendment 07, tumor imaging will 
be assessed locally based on the site’s 
standard of care imaging schedule.
MRI of Braine
Xd
X
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Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
Safety Procedures
AE Monitoring
X
X
X
X
AEs: Report all AEs occurring through 
30 days following the last dose of study 
intervention.
SAEs: Report all SAEs occurring through 
90 days following the last dose of study 
intervention, or 30 days following the last 
dose of study intervention if the 
participant initiates new anticancer 
therapy, whichever is earlier.
New diagnoses of MDS and AML should 
be reported throughout the study, 
including the follow-up period.
Complete Physical Examination 
X
Directed Physical Examination
X
X
Directed physical examination performed 
as clinically indicated prior to treatment 
administration.
Weight
X
X
Vital Signs 
(HR, DBP, SBP, RR, temperature)
X
X
X
12-lead ECG
X
12-lead ECG performed using local 
standard procedures. Additional ECGs 
performed as clinically indicated.
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Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
Hematology
X
X
X
Urinalysis
X
Chemistry
X
X
X
Thyroid Function Tests
Total or Free T3
FT4
TSH
X
X
X
Urine Pregnancy Test 
(WOCBP only)
X
X
X
Testing during EOT and Long-term 
Follow-up must be conducted as clinically 
indicated and as per local regulations 
where applicable.
Serum test is only required if urine test is 
positive or is not evaluable.
Creatinine clearance calculation
X
X
X
Creatinine clearance is calculated using 
the Cockcroft-Gault method (Table 3).
ECOG performance status
X
X
X
08KJ54

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Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
CCI
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Participants Who
Receive Induction 
Phase Treatment and 
are Not Randomized
Participants Randomized to Maintenance Phase
Notes:
* Participants who discontinue study 
treatment in the Induction Phase will 
proceed directly to Safety Follow-up.
Study Period
Safety Follow-up
EOT
Long-term Follow-up
Visit Number/Title
Safety*
DC
Safetya
Follow-upa,b
Survival
Follow-upc
Scheduling Window (Days):
30 Days After Last 
Dose (+ 7 days)
At time of 
DC
(± 3 days)
30 Days 
After Last 
Dose 
(+7 days)
Q6W for 48 
weeks Post-
randomization, 
thereafter Q9W 
post DC 
(± 7 days)
Q12W 
(±14 days)
Abbreviations:  AE = adverse event; aPTT = activated partial thromboplastin time; BID = twice daily; 
; DBP = diastolic blood pressure; 
DC = discontinuation; ECG = electrocardiogram; ECOG = Eastern Cooperative Oncology Group; 
 
 HR = heart rate; ICF = informed consent form; ID = identification; PD = progressive disease;
PRO = patient-reported outcome; RR = respiratory rate; SBP = systolic blood pressure; SoA = schedule of activities; WOCBP = women of childbearing potential.
a.
If the DC visit occurs ≥30 days from last dose of study intervention, a Safety Follow-up Visit is not required.
b.
Follow-up visits may be scheduled to coincide with Follow-Up imaging. For participants who DC for reasons other than PD, imaging continues until verified PD or 
initiation of a new antineoplastic therapy.
c.
Participants who either DC for documented PD or start a new anticancer therapy will enter the Survival Follow-up Phase and will be monitored approximately every 
12 weeks by telephone call to assess for survival status until death, withdrawal of consent, or the end of the study, whichever occurs first.
d.
Imaging to be performed at DC (±4 weeks [28 days]). If an imaging assessment was obtained within 4 weeks (28 days) prior to the date of DC, imaging is not required at 
the EOT visit. For participants who DC for PD, this is the final required tumor imaging.
e.
Participants with treated brain lesions and participants with known, asymptomatic, untreated brain metastases at diagnosis, will require imaging of the brain as a site of 
disease at DC (±4 weeks [28 days]). If an imaging assessment was obtained within 4 weeks (28 days) prior to the date of DC, imaging is not required at the EOT visit. For 
participants who DC for PD, this is the final required tumor imaging.
CCI
CCI
CCI
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1.3.4
Second Course Treatment Phase 
Study Period
Second Course Treatment
End-of-
Treatment 
Posttreatment
Comments
Treatment Cycle
C1
C2
C3
C4
C5
C6+
Safety 
Follow-upa
Imaging 
Follow-
upb
Survival 
Follow-up
Cycle Day
1
1
1
1
1
1
At time of 
discon-
tinuation
30 days from 
last dose (+7)
Q12W 
(±7)
Q12W 
(±7)
Scheduled Days
±3
±3
±3
±3
±3
Administrative Procedures
Review eligibility criteria
X
Review Concomitant Medication
X
X
X
X
X
X
X
X
Review new anticancer treatment
X
X
X
X
All anticancer therapy 
will be recorded until 
time of death or 
termination of survival 
follow-up. 
If a clinical visit is not 
feasible, this information 
may be obtained via 
telephone or email.
Survival status
------------------------------------------------------------------------------------------------------
X
All participants may be 
contacted for survival 
status at any time during 
the course of the study.
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Study Period
Second Course Treatment
End-of-
Treatment 
Posttreatment
Comments
Treatment Cycle
C1
C2
C3
C4
C5
C6+
Safety 
Follow-upa
Imaging 
Follow-
upb
Survival 
Follow-up
Cycle Day
1
1
1
1
1
1
At time of 
discon-
tinuation
30 days from 
last dose (+7)
Q12W 
(±7)
Q12W 
(±7)
Scheduled Days
±3
±3
±3
±3
±3
Clinical Assessments or Procedures
Review adverse events
X
X
X
X
X
X
X
X
X
Report all AES occurring 
through 30 days following 
the last dose of study 
intervention. SAEs: 
Report all SAEs occurring 
through 90 days following 
the last dose of study 
intervention, or 30 days 
following the last dose of 
study intervention if the 
participant initiates new 
anticancer therapy, 
whichever is earlier.
New diagnoses of MDS 
and AML should be 
reported throughout the 
study, including the 
follow-up period.
Full physical exam
X
X
Directed physical exam
X
X
X
X
X
X
Vital signs
X
X
X
X
X
X
X
X
12-Lead Electrocardiogram
X
ECOG performance status
X
X
X
X
X
X
X
X
Perform within 3 days 
prior to Second Course 
Cycle 1 and prior to 
treatment during 
treatment visits.
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Study Period
Second Course Treatment
End-of-
Treatment 
Posttreatment
Comments
Treatment Cycle
C1
C2
C3
C4
C5
C6+
Safety 
Follow-upa
Imaging 
Follow-
upb
Survival 
Follow-up
Cycle Day
1
1
1
1
1
1
At time of 
discon-
tinuation
30 days from 
last dose (+7)
Q12W 
(±7)
Q12W 
(±7)
Scheduled Days
±3
±3
±3
±3
±3
Laboratory Assessments or Procedures
Pregnancy Test (WOCBP only) - urine 
or β-HCG
X
X
X
X
X
X
X
X
X
WOCBP require a 
negative highly sensitive 
urine test within 24 hours 
(72 hours for serum) prior 
to first dose of Second 
Course study 
intervention. Serum test 
only required if urine test 
is positive or not 
evaluable. Testing during 
Second Course must be 
conducted as clinically 
indicated and as per local 
regulations, where 
applicable. More frequent 
pregnancy testing may be 
indicated, as dictated by 
local regulations.
PT/INR and aPTT/PTT
X
Perform within 3 days 
prior to Second Course 
Cycle 1
Participants receiving 
coumarin-based 
anticoagulants should
have more frequent INR 
monitoring as clinically 
indicated.
Chemistry panel
X
X
X
X
X
X
X
X
Perform within 3 days 
prior to Second Course 
Cycle 1
Hematology panel
X
X
X
X
X
X
X
X
Perform within 3 days 
prior to Second Course 
Cycle 1.
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Study Period
Second Course Treatment
End-of-
Treatment 
Posttreatment
Comments
Treatment Cycle
C1
C2
C3
C4
C5
C6+
Safety 
Follow-upa
Imaging 
Follow-
upb
Survival 
Follow-up
Cycle Day
1
1
1
1
1
1
At time of 
discon-
tinuation
30 days from 
last dose (+7)
Q12W 
(±7)
Q12W 
(±7)
Scheduled Days
±3
±3
±3
±3
±3
T3/FT3, FT4, and TSH
X
X
X
X
X
Perform within 3 days 
prior to Second Course 
Cycle 1 and every other 
cycle thereafter (C3, C5, 
C7).
Efficacy Measurements
CT/MRI imaging of chest, abdomen, 
and pelvis
X
X
X
X
Xc
Perform within 28 days
prior to Second Course 
Cycle 1.
Q12W (±7 days) from 
Second Course Cycle 1 
onwards or more 
frequently as clinically 
indicated.
If imaging was obtained 
within 28 days prior to 
discontinuation, an 
additional scan is not 
needed at discontinuation.
As of Amendment 07, 
tumor imaging will be 
assessed locally based on 
the site’s standard of care 
imaging schedule.
08KJ54

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31-JAN-2024
Study Period
Second Course Treatment
End-of-
Treatment 
Posttreatment
Comments
Treatment Cycle
C1
C2
C3
C4
C5
C6+
Safety 
Follow-upa
Imaging 
Follow-
upb
Survival 
Follow-up
Cycle Day
1
1
1
1
1
1
At time of 
discon-
tinuation
30 days from 
last dose (+7)
Q12W 
(±7)
Q12W 
(±7)
Scheduled Days
±3
±3
±3
±3
±3
MRI
Brain
X
X
X
X
Xc
Perform within 28 days
prior to Second Course 
Cycle 1 for participants 
known to be positive for 
brain metastases or who 
are clinically 
symptomatic.
If positive for brain 
metastases at the start of 
Second Course, continue 
imaging Q12W from 
Second Course Cycle 1 
onwards or more 
frequently as clinically 
indicated.
If imaging was obtained 
within 28 days prior to 
discontinuation, an 
additional scan is not 
needed at discontinuation.
Dispensing and Administration of Study Intervention
Pembrolizumab 
X
X
X
X
X
X
200 mg IV Q3W
Abbreviations: AE=adverse event; C1=Cycle 1; C2=Cycle 2; CT=computed tomography; DC=discontinuation; ECOG=Eastern Cooperative Oncology Group; FT4=free 
thyroxine; MRI=magnetic resonance imaging; Q12W=every 12 weeks; SAE=serious adverse event; T3=triiodothyronine; TSH=thyroid-stimulating hormone; WOCBP=women 
of childbearing potential.
a.
If Discontinuation visit occurs ≥30 days from last dose of study intervention, a Safety Follow-up Visit is not required. All procedures for both visits will be performed at 
the Discontinuation Visit.
b.
Follow-up visits to be scheduled to coincide with Follow-up imaging.
c.
Participants who discontinue for reasons other than radiographic disease progression will have posttreatment follow-up imaging for disease status until disease progression 
is documented radiographically per RECIST 1.1, confirmed by the site per iRECIST when clinically appropriate, initiating a new anticancer treatment, withdrawing 
consent, becoming lost to follow-up, pregnancy or death.
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2
INTRODUCTION
This clinical trial will study the combination of pembrolizumab and the polyadenosine 5′ 
diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor, olaparib, in the 
treatment of squamous non-small cell lung cancer (NSCLC).
2.1
Study Rationale
Squamous NSCLC accounts for approximately 30% to 35% of all NSCLC, with the majority 
of patients having advanced disease at diagnosis that is not amenable to surgical resection. 
There remains a high unmet medical need for patients with previously untreated metastatic 
squamous NSCLC. Although squamous cell lung cancers harbor putative oncogenic drivers, 
these have little clinical relevance and cannot be targeted. Unlike non-squamous NSCLC, no 
agent has been approved for maintenance therapy in squamous cell NSCLC. Consequently,
platinum doublets had remained the standard of care in the first-line treatment in this disease 
until most recently when immunotherapy with the use of anti-PD-1/anti-PD-L1 antibodies 
has begun to change outcomes in this patient population.
Pembrolizumab monotherapy did change the treatment paradigm for those patients with 
NSCLC whose tumors express PD-L1 ≥50% in the Phase 3 study, KEYNOTE-024. In this 
study, pembrolizumab showed statistically significant increases in OS and PFS compared 
with platinum-based chemotherapy for treatment-naïve participants with metastatic NSCLC 
whose tumors expressed high levels of the PD-L1 (tumor proportion score [TPS] ≥50%) with
no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic 
tumor aberrations, leading to regulatory approval for this indication in the US and other 
countries around the world. Approximately 30% of patients with newly diagnosed, advanced 
NSCLC highly express PD-L1 to a TPS ≥50% [Reck, M., et al 2016]; therefore, only a subset 
of patients with metastatic squamous NSCLC are potential candidates. With the findings 
from KEYNOTE-042, the TPS cutoff has been lowered, as pembrolizumab monotherapy 
significantly improved OS for participants with NSCLC who had TPS ≥1% (16.7 months vs 
12.1 months; hazard ratio [HR]: 0.81) and TPS ≥20% (17.7 months vs. 13.0 months; HR: 
0.77), compared with chemotherapy alone, while continuing to demonstrate an OS benefit in 
those with TPS ≥50% (20.0 months vs. 12.2 months; HR: 0.69). Thus, both KEYNOTE-024 
and KEYNOTE-042 showed that pembrolizumab monotherapy is effective in participants 
with PD-L1 positive metastatic NSCLC, including in participants with squamous histology.
Yet, despite these encouraging data, there is still substantial room for improvement of the 
treatment options available to these patients.
KEYNOTE-407 was designed to expand upon the efficacy of pembrolizumab by combining 
it with carboplatin and a taxane (paclitaxel or nab-paclitaxel) in patients with metastatic 
squamous NSCLC, as chemotherapy has been shown to augment the antitumor immune 
response. The study was a global, multicenter, placebo-controlled trial that randomized 559 
participants with untreated Stage IV squamous NSCLC in a 1:1 fashion to receive 
carboplatin and investigator’s choice of either paclitaxel or nab-paclitaxel in combination 
with pembrolizumab for 4 cycles followed by pembrolizumab monotherapy for up to 31 
cycles or saline placebo plus carboplatin/paclitaxel or nab-paclitaxel for 4 cycles followed by 
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saline placebo [Paz-Ares, L., et al 2018]. Patients in the saline placebo arm had the option to 
cross over to pembrolizumab monotherapy if progressive disease had been verified by BICR 
and other safety criteria were met. In the original analysis, the study demonstrated a clinically 
meaningful and statistically significant improvement in OS with an HR of 0.64 (95% CI: 
0.49-0.85, p=0.008) and a median OS of 15.9 months in the pembrolizumab combination arm 
compared to 11.3 months in the chemotherapy alone arm. Similarly, there was significant 
PFS benefit with an HR of 0.56 (95% CI: 0.45-0.70, p<0.0001) with a median PFS of 6.4 
months and 4.8 months in the pembrolizumab combination arm vs chemotherapy alone arm, 
respectively. ORR also was significantly improved in the pembrolizumab combination arm 
(58.4%) compared with chemotherapy alone (35%), p=0.0004. Importantly all subgroups 
benefited from pembrolizumab in combination with carboplatin and taxane-based 
chemotherapy, including patients whose tumors did not express PD-L1; therefore, extending 
the benefit of pembrolizumab to those with PD-L1 negative tumors.
Unfortunately, while these results have changed the paradigm in lung cancer treatment, 
patients with squamous cell NSCLC continue to progress and succumb to this disease and as 
such, there can be further improvement upon the therapeutic options available.
As PARP inhibition has been established as maintenance therapy in platinum-sensitive 
ovarian cancer, there is potential for improved outcomes in lung cancers by adding 
maintenance olaparib to pembrolizumab in those demonstrating platinum-sensitivity after 
induction pembrolizumab with chemotherapy, especially in squamous cell NSCLC where no 
maintenance agent is approved. Non-small cell lung cancer also is a prime candidate for 
olaparib use as HRD-LOH (homologous recombination deficiency loss of heterozygosity) 
scores are as high as in breast and ovarian cancers, as per The Cancer Genome Atlas. 
Furthermore, preclinical data indicate that olaparib and anti-PD(L)-1 inhibitors demonstrate 
improved therapeutic benefit than each alone, likely being synergistic effects. Therefore, 
adding olaparib as maintenance therapy to pembrolizumab in the treatment of patients with 
platinum-sensitive squamous NSCLC has the potential for further treatment benefit, which is 
clearly necessary.
Based on a critical need for new therapies in 1L treatment of Stage IV squamous NSCLC, we 
are undertaking this Phase 3 study of pembrolizumab plus standard-of-care chemotherapy 
(carboplatin/paclitaxel or nab-paclitaxel) followed by pembrolizumab and maintenance 
olaparib. 
2.2
Background
2.2.1
Olaparib
Olaparib (AZD2281, KU-0059436) is a potent PARP inhibitor (PARP1, 2, and 3) that is 
being developed as a monotherapy as well as for combination with chemotherapy, ionizing 
radiation and other anticancer agents including novel agents and immunotherapy.
PARP inhibition is a novel approach to targeting tumors with deficiencies in DNA repair 
mechanisms. PARP enzymes are essential for repairing DNA single strand breaks (SSBs). 
Inhibiting PARPs leads to the persistence of SSBs, which are then converted to the more 
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serious DNA double strand breaks (DSBs) during the process of DNA replication. During the 
process of cell division, DSBs can be efficiently repaired in normal cells by HRR. Tumors 
with HRD, such as ovarian cancers in patients with breast cancer susceptibility gene 1/2 
(BRCA1/2) mutations (BRCAm), cannot accurately repair the DNA damage, which may 
become lethal to cells as it accumulates. In such tumor types, olaparib may offer a potentially 
efficacious and less toxic cancer treatment compared with currently available chemotherapy 
regimens.
Olaparib traps the inactive form PARP on DNA at sites of SSBs, thereby preventing their 
repair [Helleday, T. 2011] [Murai, J., et al 2012]. Olaparib has demonstrated efficacy in 
ovarian, prostate, and pancreatic tumors with BRCA1 and BRCA2 mutations and has shown 
proof of concept in tumors with ataxia-telangiectasia mutated (ATM) and other indicators of 
HRD. The specificity of olaparib for binding PARP at the replication fork during DNA 
replication is believed to have applicability to tumors associated with mutations in HRR.
Refer to the Investigator’s Brochure (IB)/approved labeling for detailed background 
information on olaparib.
2.2.2
Pembrolizumab
Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody 
(mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction 
with PD-L1 and programmed cell death ligand 2 (PD-L2). Based on preclinical in vitro data, 
pembrolizumab has high affinity and potent receptor blocking activity for PD-1. 
Pembrolizumab has an acceptable preclinical safety profile and is in clinical development as 
an intravenous (IV) immunotherapy for advanced malignancies. Keytruda® (pembrolizumab) 
is indicated for the treatment of patients across a number of indications. For more details on 
specific indications refer to the Investigator’s Brochure (IB).
2.2.3
Non-small Cell Lung Cancer (NSCLC)
Lung cancer is the most common malignancy in the world, with an estimated incidence in 
2012 of 2.1 million and an associated 1.76 million deaths [Bray, F., et al 2018]. Among 
males, the estimated incidence rates of new diagnoses are highest in Central and Eastern 
Europe (53.5 per 100,000/year) and Eastern Asia (50.4), while the incidence rates among 
females are highest in North America (33.8), Northern Europe (23.7), and Eastern Asia 
(19.2) [Ferlay, J., et al 2015].
Non-small cell lung cancer represents approximately 80% to 85% of all lung cancer
[National Cancer Institute 2016] and consists of 2 major types: non-squamous carcinoma 
(~65%-70% of cases) and squamous carcinoma (~30%-35% of cases) [Ferlay, J., et al 2015] 
[Arnold, M., et al 2015]. At the time of diagnosis, approximately 80% of patients with lung 
cancer have locally advanced or metastatic disease that is not amenable to surgical resection
[National Cancer Institute 2012]. Of those patients diagnosed with early stage NSCLC and 
treated with surgery, a significant percentage subsequently develop distant recurrence 
[Pisters, K. M. W. and Le Chevalier, T. 2005]. These factors contribute to the dismal 5-year 
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relative survival rates of 17.7% in patients diagnosed with NSCLC, and a mere 4.3% in those 
with advanced/metastatic disease [National Cancer Institute 2016a]. 
2.2.4
Current Treatment Options and Unmet Medical Need
There remains a high unmet medical need for patients with previously untreated metastatic 
squamous NSCLC. 
Prior to the use and availability of pembrolizumab, limited therapeutic options were available 
for first-line treatment of metastatic squamous NSCLC beyond standard platinum-based 
chemotherapy. Regimens have included cisplatin or carboplatin in combination with 
paclitaxel, gemcitabine, pemetrexed, or docetaxel [Peters, S., et al 2012]. Multiple Phase 3 
studies have shown similar efficacy for most platinum-based chemotherapies in participants 
with metastatic NSCLC [Schiller, J. H., et al 2002] [Socinski, Mark A., et al 2012] 
[Scagliotti, G. V., et al 2008] [Thatcher, N., et al 2015]. Carboplatin with either paclitaxel or 
nab-paclitaxel is one of the most widely accepted regimens for chemotherapy-naïve patients 
with metastatic squamous NSCLC [National Comprehensive Cancer Network 2015]. In a 
randomized, Phase 3 study that compared the efficacy and safety of albumin-bound 
paclitaxel (nab-paclitaxel) plus carboplatin with solvent-based paclitaxel plus carboplatin in 
advanced NSCLC, the ORR (primary endpoint) was 33% in the nab-paclitaxel group and 
25% in the paclitaxel group. For participants with squamous histology, the ORR was 41% 
and 24%, respectively. However, neither PFS (median, 6.3 vs 5.8 months) nor OS (median, 
12.1 vs 11.2 months) differed significantly between the nab-paclitaxel and paclitaxel groups. 
Significantly less AEs of neuropathy, neutropenia, arthralgia, and myalgia of at least Grade 3 
severity occurred among participants on nab-paclitaxel and less thrombocytopenia and 
anemia occurred among participants on paclitaxel [Socinski, Mark A., et al 2012]. 
While squamous cell lung cancers harbor putative oncogenic drivers, these have little clinical 
relevance and cannot be targeted, unlike non-squamous lung cancers. Two agents efficacious 
in treating non-squamous NSCLC are the anti-metabolite, pemetrexed, and the anti-
angiogenic agent, bevacizumab, neither of which is used to treat squamous NSCLC
[Thatcher, N., et al 2015]. For patients with squamous NSCLC, pemetrexed-based therapies 
result in shorter survival times compared with patients with non-squamous NSCLC 
[Scagliotti, G., et al 2009], and bevacizumab has the toxicity concern of pulmonary 
hemorrhage [Sandler, A., et al 2006]. Necitumumab in combination with gemcitabine and 
cisplatin was approved by the US FDA and the EMA in squamous NSCLC based on the 
SQUIRE trial study [Thatcher, N., et al 2015]; however, because the absolute benefit from 
the addition of necitumumab to platinum-based chemotherapy remains small, this 
combination does not have widespread use.
Pembrolizumab has led to a paradigm shift from standard platinum-based doublets for the 
first-line treatment of NSCLC. KEYNOTE-024 showed statistically significant increases in 
OS and PFS for pembrolizumab compared with platinum-based chemotherapy in treatment-
naïve participants with metastatic NSCLC whose tumors expressed high levels of the PD-L1 
(TPS ≥50%) with no EGFR or ALK genomic tumor aberrations. With the findings from 
KEYNOTE-042, the TPS cutoff has been lowered, as pembrolizumab monotherapy 
significantly improved OS for participants with NSCLC who had TPS ≥1% (16.7 months vs 
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12.1 months; HR: 0.81) and TPS ≥20% (17.7 months vs. 13.0 months; HR: 0.77), compared 
with chemotherapy alone, while continuing to demonstrate an OS benefit in those with TPS 
≥50% (20.0 months vs 12.2 months; HR: 0.69). Thus, both KEYNOTE-024 and KEYNOTE-
042 showed that pembrolizumab monotherapy is effective in participants with PD-L1 
positive metastatic NSCLC, including those with squamous histology.
KEYNOTE-407 has further redefined the standard of care for patients with squamous 
NSCLC. In the original report with a medial follow-up of 7.8 months (range, 0.1 to 19.1), the 
study demonstrated a clinically meaningful and statistically significant improvement in OS 
with an HR of 0.64 (95% CI: 0.49-0.85, p=0.008) and a median OS of 15.9 months in the 
pembrolizumab combination arm compared to 11.3 months in the chemotherapy alone arm. 
Similarly, there was significant PFS benefit with an HR of 0.56 (95% CI: 0.45-0.70, 
p<0.0001) with a median PFS of 6.4 months and 4.8 months in the pembrolizumab 
combination arm vs chemotherapy alone arm, respectively. ORR also was significantly 
improved in the pembrolizumab combination arm (58.4%) compared with chemotherapy 
alone (35%), p=0.0004. In a subsequent 3-year OS analysis from KEYNOTE-407 (median 
time from randomization to data cutoff, 40.1 months; range 33.1–49.4 months), 
pembrolizumab plus platinum-doublet chemotherapy demonstrated long-term OS (HR, 0.71 
[95% CI, 0.59–0.86]; estimated 3-year OS rates, 29.7% vs 18.2%), PFS (HR, 0.59 [95% CI, 
0.49–0.71]; estimated 3-year PFS rates, 16.1% vs 6.5%), ORR (62.6% vs 38.8%), and DOR 
(medians, 9.0 vs 4.9 months) benefits compared with placebo plus chemotherapy in patients 
with previously untreated metastatic squamous NSCLC regardless of PD-L1 expression
[Robinson, A. G., et al 2021]. Importantly, all subgroups benefited from pembrolizumab in 
combination with carboplatin and taxane-based chemotherapy, including patients whose 
tumors did not express PD-L1; therefore, extending the benefit of pembrolizumab to those 
with PD-L1 negative tumors.
Despite these impressive results, patients with advanced squamous NSCLC still have an 
urgent need for new agents that can be combined with a pembrolizumab backbone to increase 
response rates, decrease the risk of progression, and decrease the risk of death [Gandhi, L., et 
al 2018].
2.2.5
Pharmaceutical and Therapeutic Background
2.2.5.1
Inhibition of PARP as a Target for Cancer Therapy
PARP1 and PARP2 are zinc-finger DNA-binding enzymes that play a critical role in DNA 
repair [Ame, J. C., et al 2004] by sensing DNA damage and converting it into intracellular 
signals that activate the base excision repair (BER) and SSB repair pathways. When a break 
in DNA occurs, PARP enzymes are recruited to, and bind at, the end of the broken DNA 
strands, activating their enzymatic activity. PARP subsequently catalyzes the addition of long 
polymers of ADP-ribose onto several other proteins associated with chromatin (eg, PARP, 
histones, DNA repair proteins), resulting in chromatin relaxation, rapid recruitment of DNA 
repair proteins, and efficient repair of the break. 
Under normal conditions, HRR is the preferred pathway for repairing DNA damage as it is 
associated with a lower rate of errors compared with other forms of DNA repair 
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[Prakash, R., et al 2015]. During DNA replication (S phase), pre-existing or chemotherapy-
induced SSBs are converted to DSBs if not adequately repaired by intracellular mechanisms 
[Fong, Peter C., et al 2009], such as HRR. Cells unable to perform HRR (eg, due to 
inactivation of genes required for homologous recombination, such as BRCA1 or BRCA2) 
are more likely to use the error-prone non-homologous end-joining (NHEJ) or alternative 
(alt)-NHEJ pathways to repair these DSBs and risk accumulating multiple lesions or loss of 
heterozygosity (LOH) due to an increase in deletions and accompanying genomic instability. 
Over time, the accumulation of excessive DNA errors in combination with the inability to 
complete S phase (ie, because of stalled replication forks due to PARP inhibitor 
administration), leads to cell death demonstrating that PARP inhibition is synthetically lethal
in the context of BRCAm [Farmer, H., et al 2005] [Bryant, H. E., et al 2005]. Cells without 
SSBs or with intact HRR, such as somatic tissue, replicate normally in the presence of a 
PARP inhibitor, thereby minimizing toxicity.
Treatment with PARP inhibitors could represent a novel opportunity to selectively kill cancer 
cells with deficiencies in DNA repair pathways.
Additionally, PARP inhibitors, by causing DNA damage can activate the cGAS-STING 
pathway, increasing type I interferons, immunomodulatory molecules (eg, CXCL10, CCL5), 
and CD4+/CD8+ lymphocytes and upregulating PD-L1 and other checkpoint inhibitors in 
both BRCA-proficient and BRCA-deficient cells. Preclinically, the combination of olaparib 
and anti-PD(L)1 inhibitors demonstrate improved therapeutic benefit than each alone, likely 
being synergistic [Higuchi, T., et al 2015] [Huang, J., et al 2015] [Jiao, S., et al 2017] 
[Parkes, E. E., et al 2017]; therefore, there is a rationale for the combination of olaparib and 
pembrolizumab.
2.2.5.2
Inhibition of PD-1 as a Target for Cancer Therapy
The importance of intact immune surveillance function in controlling outgrowth of neoplastic 
transformations has been known for decades [Disis, M. L. 2010]. Accumulating evidence 
shows a correlation between tumor-infiltrating lymphocytes in cancer tissue and favorable 
prognosis in various malignancies. In particular, the presence of CD8+ T-cells and the ratio 
of CD8+ effector T-cells/FoxP3+ regulatory T-cells (T-regs) correlates with improved 
prognosis and long-term survival in solid malignancies, such as ovarian, colorectal, and 
pancreatic cancer; hepatocellular carcinoma; malignant melanoma; and renal cell carcinoma. 
Tumor-infiltrating lymphocytes can be expanded ex vivo and reinfused, inducing durable 
objective tumor responses in cancers such as melanoma [Dudley, M. E., et al 2005] [Hunder, 
N. N., et al 2008].
The PD-1 receptor-ligand interaction is a major pathway hijacked by tumors to suppress 
immune control. The normal function of PD-1, expressed on the cell surface of activated 
T-cells under healthy conditions, is to down-modulate unwanted or excessive immune 
responses, including autoimmune reactions. PD-1 (encoded by the gene Pdcd1) is an 
immunoglobulin (Ig) superfamily member related to cluster of differentiation 28 (CD28) and 
cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) that has been shown to negatively 
regulate antigen receptor signaling upon engagement of its ligands (PD-L1 and/or PD-L2) 
[Greenwald, R. J., et al 2005] [Okazaki, T., et al 2001]. 
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The structure of murine PD-1 has been resolved [Zhang, X., et al 2004]. PD-1 and its family 
members are type I transmembrane glycoproteins containing an Ig-variable–type (IgV type) 
domain responsible for ligand binding and a cytoplasmic tail responsible for the binding of 
signaling molecules. The cytoplasmic tail of PD-1 contains 2 tyrosine-based signaling motifs, 
an immunoreceptor tyrosine-based inhibition motif, and an immunoreceptor tyrosine-based 
switch motif. Following T-cell stimulation, PD-1 recruits the tyrosine phosphatases, SHP-1 
and SHP-2, to the immunoreceptor tyrosine-based switch motif within its cytoplasmic tail, 
leading to the dephosphorylation of effector molecules such as CD3 zeta (CD3ζ), protein
kinase C-theta (PKC-θ), and zeta-chain-associated protein kinase (ZAP70), which are 
involved in the CD3 T-cell signaling cascade [Okazaki, T., et al 2001] [Chemnitz, J. M., et al 
2004] [Sheppard, K-A, et al 2004] [Riley, J. L. 2009]. The mechanism by which PD-1 down-
modulates T-cell responses is similar to, but distinct from, that of CTLA-4, because both 
molecules regulate an overlapping set of signaling proteins [Parry, R. V., et al 2005] 
[Francisco, L. M., et al 2010]. As a consequence, the PD-1/PD-L1 pathway is an attractive 
target for therapeutic intervention in squamous NSCLC.
2.2.5.3
Homologous Recombination Repair in Solid Tumors
Defects in DNA repair drive the genesis of several solid tumors, most notably ovarian and 
pancreatic. DNA strand breaks occur both as part of the recombination and replication 
process as well as following intercalating chemotherapy or DNA damaging radiotherapy. 
HRR defective tumors are intrinsically sensitive to PARP inhibitors, both in tumor models in 
vivo [Rottenberg, S., et al 2008] [Hay, T., et al 2009] and in the clinic [Fong, Peter C., et al 
2009] [Tutt, A., et al 2010] [Mateo, J., et al 2015] [Kaufman, B., et al 2015]. The main 
mechanism of action for olaparib results from the trapping inactive PARP on SSBs 
preventing their repair [Helleday, T. 2011] [Murai, J., et al 2012] and excessive conversion 
into the more serious DSBs, which are lethal, or results in incomplete/inaccurate repair of the 
damaged strand leading to a LOH with subsequent aberrant protein translation and function. 
Normally, the process of HRR corrects DSBs using proteins such as BRCA1 and BRCA2; 
however, the HRR armamentarium includes proteins coded by at least 13 other genes 
including ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, 
RAD51B, RAD51C, RAD51D, and RAD54L. For example, the protein coded by the ATM
gene also is involved in the repair of DSB. ATM is activated by DSB and phosphorylates 
diverse cellular proteins, leading to cell-cycle arrest (eg, mediator of DNA damage 
checkpoint 1 [MDC1], checkpoint kinase 2), activates the tumor suppressor p53, contributes 
to chromatin relaxation and remodeling, and activates nuclear factor kappa-light-chain-
enhancer of activated B cells (NF-κB). Defective ATM increases the risk of breast, 
gastrointestinal, lung, and lymphoid cancers. Moreover, defective ATM also appears to 
correlate with a poor prognosis, but the conferred risk has not been quantified. 
A small percentage of tumors have loss-of-function mutations in HRR genes, with BRCA1, 
BRCA2, and ATM being the best characterized and most frequently mutated [Watkins, J. A., 
et al 2014] [Marquard, A. M., et al 2015] [Choi, M., et al 2016] [Lord, C. J. 2016]. 
Approximately half of the detected HRRm are germline mutations [Mateo, J., et al 2015]. 
While an adverse prognostic impact of germline BRCA2 mutations has been described in 
prostate cancer [Castro, E., et al 2015], it is less clear if other germline or somatic HRR gene 
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mutations are associated with similar adverse clinical outcomes. To date, HRRm has not 
been associated with specific patient or tumor characteristics.
Notably, in NSCLC, HRD-LOH scores are as high as in breast and ovarian cancers, as per 
The Cancer Genome Atlas data [Cerami, E., et al 2012] [Gao, J., et al 2013].
2.2.6
Preclinical and Clinical Studies
For a summary of preclinical and clinical study data for pembrolizumab and olaparib, refer to 
their respective IBs.
2.2.7
Ongoing Clinical Studies
For a summary of ongoing clinical study data for pembrolizumab and olaparib, refer to their 
respective IBs.
2.2.7.1
Information on Other Trial-related Therapy
A platinum doublet with a taxane is the most commonly used 1L chemotherapy for chemo-
naïve metastatic squamous NSCLC patients, respectively. Pembrolizumab in combination 
with carboplatin and paclitaxel or nab-paclitaxel is also being evaluated in a randomized 
Phase 3 study, KN407, and data were positive at the interim analysis [Paz-Ares, L., et al 
2018]. Based on safety and efficacy data from these combination studies with 
pembrolizumab and other PD-1/PD-L1 inhibitors, the current study will use pembrolizumab 
in combination with carboplatin plus paclitaxel or nab-paclitaxel at approved doses.
2.3
Benefit/Risk Assessment
It cannot be guaranteed that participants in clinical studies will directly benefit from 
treatment during participation, as clinical studies are designed to provide information about 
the safety and effectiveness of an investigational medicine.
Additional details regarding specific benefits and risks for participants participating in this 
clinical study may be found in the accompanying IB and informed consent documents.
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3
HYPOTHESES, OBJECTIVES, AND ENDPOINTS
In male and female participants with Stage IV squamous NSCLC with stable disease, partial 
response, or complete response following induction treatment with pembrolizumab combined 
with carboplatin and a taxane (paclitaxel or nab-paclitaxel):
Objectives
Endpoints
Primary
•
Objective: To compare pembrolizumab 
plus maintenance olaparib with 
pembrolizumab plus placebo with respect 
to progression-free survival (PFS) 
assessed according to RECIST 1.1
(Section 4.2.1.1) by blinded independent 
central review (BICR).
•
Hypothesis (H1): Pembrolizumab plus 
maintenance olaparib is superior to 
pembrolizumab plus placebo with respect 
to PFS per RECIST 1.1 (Section 4.2.1.1)
by BICR.
•
PFS, the time from the date of 
randomization until either documented
disease progression or death due to any 
cause, whichever occurs first.
•
Objective: To compare pembrolizumab 
plus maintenance olaparib with 
pembrolizumab plus placebo with respect 
to overall survival (OS).
•
Hypothesis (H2): Pembrolizumab plus 
maintenance olaparib is superior to 
pembrolizumab plus placebo with respect 
to OS.
•
OS, the time from the date of 
randomization to death due to any 
cause.
As of Interim Analysis 3, this study did not meet its primary objective (pembrolizumab 
plus maintenance Olaparib is superior to pembrolizumab plus placebo with respect to OS). 
The final analysis will not be performed.
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Objectives
Endpoints
Secondary
•
Objective: To evaluate the safety and 
tolerability of pembrolizumab plus 
maintenance olaparib compared to 
pembrolizumab plus placebo.
•
Adverse events (AEs)
•
Discontinuation of study intervention 
due to AEs
•
Objective: To evaluate the change from 
baseline (at randomization) and the time 
to true deterioration (TTD) in global 
health status/quality of life (QoL), cough, 
chest pain, dyspnea and physical 
functioning following treatment with 
pembrolizumab plus maintenance 
olaparib compared to pembrolizumab 
plus placebo.
•
Change from baseline (at 
randomization) and the time to true 
deterioration (TTD) defined as the 
time from baseline (at randomization) 
to the first onset of a ≥10-point 
deterioration with confirmation by the 
subsequent visit of a ≥10-point 
deterioration in the following 
European Organization for Research 
and Treatment of Cancer Quality of 
Life Questionnaire (EORTC QLQ) and
QLQ Lung Cancer Module 13 (LC13) 
scales/items:
- Global health status/QoL (C30/Items 
29 and 30)
- Cough (LC13/Item 1)
- Chest pain (LC13/Item 10)
- Dyspnea (C30/Item 8)
- Physical functioning (C30/Items 1 –
5)
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Objectives
Endpoints
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4
STUDY DESIGN
4.1
Overall Design
This is a Phase 3, randomized, placebo-controlled, multisite, double-blind study of the 
combination of pembrolizumab plus carboplatin/taxane (paclitaxel or nab-paclitaxel)
followed by continued pembrolizumab and olaparib maintenance compared with continued 
pembrolizumab and placebo in participants with metastatic squamous NSCLC in need of 
first-line treatment.
This study will be conducted in 4 phases: Screening, an Induction Phase, a Maintenance 
Phase, and Long-term Follow-up. An optional Second Course Phase is also available. The 
study design overview is presented in Figure 1 and described below.
The Induction Phase is an open-label, 12-week period during which approximately 857 
eligible participants will be enrolled to receive 4 cycles of pembrolizumab and carboplatin 
plus paclitaxel or nab-paclitaxel; refer to Table 2. During the Induction Phase, participants 
will have study visits every 3 weeks for assessments. Tumor response during the Induction 
Phase will be evaluated using RECIST 1.1, with radiographic imaging at Weeks 6 and 12 
(±7 days) from the date of the first dose (Cycle 1) of study intervention. All imaging must be 
submitted to the central imaging vendor as soon as possible for expedited BICR to determine 
overall responses for each Induction Phase scan prior to randomization into the Maintenance 
Phase. 
Note: As of Amendment 07, disease progression will no longer be centrally verified; 
participants will only be assessed locally. 
The Maintenance Phase is a randomized, double-blind period during which approximately 
590 participants will be eligible for randomization to pembrolizumab combined with 
maintenance olaparib or pembrolizumab combined with maintenance olaparib placebo
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A detailed list of inclusion criteria specific for entering the Maintenance Phase is provided in 
Section 5.1.
Randomization will be stratified by Eastern Cooperative Oncology Group (ECOG) 
performance status score (0 or 1) at Pre-randomization Visit, PD-L1 expression (TPS <50%
vs ≥50%), and response at the latest evaluable scan obtained prior to randomization (CR/PR 
vs SD). 
Eligible participants who enter the Maintenance Phase may receive a maximum of 35 cycles 
of pembrolizumab during the study (4 cycles during the Induction Phase and 31 cycles during 
the Maintenance Phase). If pembrolizumab is stopped due to toxicity or completion of 
35 cycles, the participant may continue with olaparib until specific discontinuation criteria 
are met (Section 7.1). If olaparib is stopped due to toxicity, the participant may continue to 
receive pembrolizumab for a maximum of 31 cycles during the Maintenance Phase or until 
specific discontinuation criteria are met (Section 7.1).
Table 2
Treatment Plan
Induction Phase
(Cycles 1 to 4)
Maintenance Phase
(Up to 31 Cycles)
•
Pembrolizumab 200 mg IV Q3W on Day 1 
•
Carboplatin titrated to an AUC of 6 mg/mL/min 
IV Q3W on Day 1 
•
Paclitaxel 200 mg/m2 IV Q3W
OR
Nab-paclitaxel 100 mg/m2 on Day 1, Day 8, and 
Day 15
•
Pembrolizumab 200 mg IV Q3W on Day 1
-for a maximum of 31 cycles or until specific 
discontinuation criteria are met (Section 7.1)
•
Olaparib 300 mg BID daily
- will continue until specific discontinuation
criteria are met (Section 7.1).
•
OR
•
Pembrolizumab 200 mg IV Q3W on Day 1
-for a maximum of 31 cycles or until specific 
discontinuation criteria are met (Section 7.1)
•
Olaparib placebo BID daily
- will continue until specific discontinuation 
criteria are met (Section 7.1).
Abbreviations: AUC=area under the concentration-time curve; BID= twice daily; Q3W=every 3 weeks.
Note: As of Amendment 07, participants who are confirmed to be actively taking placebo should discontinue taking the 
placebo intervention and continue in the study.
Efficacy will be evaluated using PFS per RECIST 1.1, as determined by BICR, and OS. 
Participants randomized into Maintenance Phase will be evaluated with radiographic imaging 
to assess response to treatment at regular intervals throughout the study as described in 
Section 8.2.1. The images prior to initiating the Maintenance Phase should be performed 
within 28 days of the date of randomization; these imaging studies will serve as the new 
baseline. All imaging obtained on study, including imaging showing Investigator-assessed 
progressive disease (PD), will be submitted to the central imaging vendor for review, which 
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will assess images using RECIST 1.1 for verification of PD and for determination of ORR
(Section 8.2.1.4). Initial tumor imaging showing site-assessed PD should be submitted 
immediately for verification by BICR prior to discontinuation of study intervention.
Participants in the Maintenance Phase will receive randomly assigned study intervention 
until disease progression is radiographically documented and, when clinically appropriate, 
confirmed by the site per modified Response Evaluation Criteria in Solid Tumors 1.1, for 
immune-based therapeutics (iRECIST), or unacceptable AEs, intercurrent illness that 
prevents further administration of study intervention, investigator’s decision to discontinue 
the participant, noncompliance with study intervention or procedure requirements, or 
administrative reasons requiring cessation of treatment (Section 7.1). Pembrolizumab will 
continue for a maximum of 31 cycles, or until specific discontinuation criteria are met 
(Section 7.1). Olaparib will continue until specific discontinuation criteria are met 
(Section 7.1).
Participants treated with pembrolizumab who complete 35 cycles of pembrolizumab during 
the study (4 cycles during the Induction Phase and 31 cycles during the Maintenance Phase) 
with SD, CR, or PR, and without a current AE, may be eligible for retreatment with up to an 
additional 17 cycles (approximately 1 year) of pembrolizumab if they experience 
radiographic disease progression after stopping treatment in the Maintenance Phase. This 
retreatment is termed Second Course Treatment and is only available if the study remains 
open and the participant meets the criteria listed in Section 8.12.5. Responses or events of 
progression that occur during Second Course Treatment will not be counted toward the ORR 
and PFS endpoints in this study.
Adverse event (AE) monitoring will be ongoing throughout the trial and graded in severity 
according to the guidelines outlined in the National Cancer Institute Common Terminology 
Criteria for Adverse Events (NCI CTCAE) v4.0 (Section 8.4). Adverse events will be 
reported by the Investigator or delegate from randomization through 30 days following 
cessation of study Intervention. Serious AEs (SAEs) will be reported by the investigator or 
delegate from the start of Induction Phase treatment through either 90 days following 
cessation of study intervention or 30 days following cessation of study intervention if the 
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Participants who discontinue treatment for reasons other than verified PD will have Long-
term Follow-up for disease status (including imaging) until PD, initiating a new anticancer
therapy, withdrawing consent for study participation, or becoming lost to follow up. After 
documented PD, each participant will be contacted by telephone approximately every 
12 weeks (84 ±14 days) for survival until withdrawal of consent to participate in the study, 
becoming lost to follow up, death, or end of the study, whichever occurs first.
Three interim efficacy analyses and 1 final analysis are planned in this study. Details 
regarding interim analyses are provided in Section 9.7. An external data monitoring 
committee (eDMC) will serve as the primary reviewer of the treatment-level results and will 
make recommendations for discontinuation of the study or modification to an Executive 
Oversight Committee (see Section 10.1.4 Committees Structure) of the Sponsor. The eDMC 
responsibilities and review schedules will be outlined in the eDMC charter.
Specific procedures to be performed during the study, as well as their prescribed times and 
associated visit windows, are outlined in the SoA in Section 1.3. Details of each procedure 
are provided in Section 8.
Note: Based on the data from an interim safety and efficacy analysis (IA3) (data cutoff 
21-SEP-2023), the external Data Monitoring Committee recommended to remove the final 
analysis. The pembrolizumab plus Olaparib arm did not meet the statistical criterion for 
success for the primary endpoint of OS at Interim Analysis 3, nor is it expected to meet the 
endpoint at the planned prespecified final analysis. Based on these data, the study was 
unblinded as of 15-DEC-2023. The prespecified final analysis of the study described in the 
SAP will not be performed. Selected analyses of safety endpoints will be performed at the 
end of the study; there will be no further analyses for efficacy and ePRO endpoints.
Note: In alignment with the study-specific investigator letter dated 07-DEC-2023, all study 
participants still receiving study treatment will discuss next steps with the Investigator. They 
should continue to receive therapy on study and undergo modified protocol study procedures.
There were no new safety signals identified in the IA3 analysis. Participants who are 
confirmed to be actively taking placebo should discontinue taking the placebo intervention 
and continue in the study. Participants currently on study treatment with Olaparib will be 
able to continue treatment per Investigator's discretion after discussion with their physician. 
Participants who are potential candidates for Second Course treatment will continue in 
Efficacy Follow-up. Participants currently undergoing or who will undergo Second Course 
with pembrolizumab monotherapy can continue or start treatment per investigator’s 
discretion under this protocol or under an extension study.
4.2
Scientific Rationale for Study Design
In contrast to non-squamous NSCLC, no agent has been approved for maintenance therapy in 
squamous NSCLC. The results of KEYNOTE-407 have led to a paradigm shift in the 
treatment of front-line treatment of patients with Stage IV squamous NSCLC and the new 
standard of care in this population is 4 cycles of pembrolizumab combined with carboplatin 
and paclitaxel (or nab-paclitaxel) followed by pembrolizumab for up to a total of 35 cycles.
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Unfortunately, while these results have changed the paradigm in squamous NSCLC, patients 
with this disease progress with first-line therapy and ultimately succumb to this malignancy. 
A potential opportunity for improvement in this high area of unmet medical need is by 
adding a PARP inhibitor to pembrolizumab in the maintenance setting. PARP inhibition has 
been established as a maintenance therapy for platinum-sensitive populations in ovarian 
cancer, regardless of BRCA status. Clinical benefit from platinum may predict for sensitivity 
to Olaparib maintenance, which may extend beyond ovarian cancer. Olaparib, when added to 
pembrolizumab, may continue to induce DNA damage and upregulate PD-L1, leading to 
synergism and further delaying progressive disease in squamous NSCLC. Notably, in the 
MEDIOLA trial, a Phase 2 basket study that included patients with SCLC, an improvement 
in overall survival was demonstrated when olaparib-durvalumab was administered following 
olaparib in those with relapsed disease.  
Importantly, olaparib in combination with pembrolizumab is being evaluated in an ongoing 
nonrandomized, multicenter, multicohort, open-label, Phase 1b/2 study (KEYNOTE-365) in 
participants with metastatic castration-resistant prostate cancer (mCRPC) and the 
combination has been generally well tolerated, with no new safety signals identified for 
either compound.
A recently published Phase 2 trial of the PARP inhibitor veliparib in combination with 
carboplatin and paclitaxel vs carboplatin and paclitaxel alone as first-line therapy in patients 
with advanced NSCLC showed clinically meaningful, but not statistically significant, benefit 
[Ramalingam, S. S., et al 2017]. This benefit was more pronounced in patients with 
squamous histology, with a median PFS of 6.5 months in the group of patients treated with 
veliparib vs 4.1 months in the placebo group, HR 0.54, 95% CI, 0.26-1.12; p=0.098.
This trial is a Phase 3, double-blind study designed and powered to determine whether 
continued pembrolizumab with maintenance olaparib leads to improved PFS and OS when 
compared with continued pembrolizumab and maintenance olaparib placebo in participants
with stable disease or partial/complete response to 4 cycles of induction pembrolizumab 
combined with chemotherapy. Randomization to the Maintenance Phase after all participants 
complete induction therapy, isolates the treatment effect of the combination of continued 
pembrolizumab and maintenance olaparib compared with pembrolizumab alone.
Based on a critical need for new therapies in 1L treatment of Stage IV squamous NSCLC and 
the growing scientific evidence for the potential synergism for the combination of 
pembrolizumab and olaparib in NSCLC, we are undertaking this Phase 3, double-blind study 
of pembrolizumab plus chemotherapy (carboplatin/paclitaxel or nab-paclitaxel) followed by 
pembrolizumab and maintenance olaparib. Adding olaparib as maintenance therapy to 
pembrolizumab in platinum-sensitive squamous NSCLC likely has the potential for further 
improvements in this malignancy.
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4.2.1
Rationale for Endpoints
4.2.1.1
Efficacy Endpoints
This study has dual primary endpoints of PFS and OS.
This study will use PFS as assessed by BICR according to RECIST 1.1 (see 
Section 4.2.1.1.1) as a primary endpoint. Progression-free survival is an acceptable measure 
of clinical benefit for a late-stage study that demonstrates superiority of a new antineoplastic 
therapy, especially if the magnitude of the effect is large and the therapy has an acceptable 
risk/benefit profile. The use of BICR and RECIST 1.1 to assess PFS is typically considered 
acceptable by regulatory authorities. Images will be submitted to a central imaging vendor 
and read by independent central reviewers blinded to treatment assignment to minimize bias 
in the response assessments. In addition, the final determination of radiologic progression 
will be based on the central assessment of progression, rather than a local site 
investigator/radiology assessment. Expedited verification of radiologic progression by BICR
will be communicated to the site by email. 
Overall survival has been recognized as the gold standard for the demonstration of 
superiority of a new antineoplastic therapy in randomized clinical studies.
4.2.1.1.1
RECIST 1.1
RECIST 1.1 will be used by the BICR when assessing images for efficacy measures and by 
the local site when determining eligibility (Section 8.2.1.5). Although traditional RECIST 1.1 
references a maximum of 5 target lesions in total and 2 per organ, this protocol has 
implemented a modification to RECIST 1.1 to allow a maximum of 10 target lesions in total 
and 5 per organ.
4.2.1.1.2
iRECIST
RECIST 1.1 will be adapted to account for the unique tumor response characteristics seen 
following treatment with pembrolizumab (Section 8.2.1.5). Immunotherapeutic agents such 
as pembrolizumab 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 patients treated with 
pembrolizumab may manifest a clinical response after an initial increase in tumor burden or 
even the appearance of new lesions. Thus, standard RECIST 1.1 may not provide an accurate 
response assessment of immunotherapeutic agents such as pembrolizumab. Based on an 
analysis of participants with melanoma enrolled in KEYNOTE-001 (KN001), 7% of 
evaluable participants experienced delayed or early tumor pseudo-progression. Of note, 
participants who had PD by RECIST 1.1, but not by the immune-related response criteria 
[Wolchok, J. D., et al 2009], had longer overall survival than participants with PD by both 
criteria [Hodi, F. S., et al 2014]. Additionally, the data suggest that RECIST 1.1 may 
underestimate the benefit of pembrolizumab in approximately 15% of participants. These 
findings support the need to apply a modification to RECIST 1.1 that considers the unique 
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patterns of atypical responses in immunotherapy and enables treatment beyond initial 
radiographic progression, if the participant is clinically stable.
Modified RECIST 1.1 for immune-based therapeutics (iRECIST) assessment has been 
developed and published by the RECIST Working Group, with input from leading experts 
from industry and academia, along with participation from the US Food and Drug 
Administration and the European Medicines Agency [Seymour, L., et al 2017]. The 
unidimensional measurement of target lesions, qualitative assessment of nontarget lesions, 
and response categories are identical to RECIST 1.1, until progression is seen by RECIST 
1.1. However, if a participant is clinically stable, additional imaging may be performed to 
confirm radiographic progression. iRECIST will be used by investigators to assess tumor 
response and progression and make treatment decisions.
4.2.1.2
Safety Endpoints
Safety parameters commonly used for evaluating investigational systemic anticancer 
treatments are included as safety endpoints including, but not limited to, the incidence of, 
causality, and outcome of AEs/SAEs; and changes in vital signs and laboratory values. 
Adverse events will be assessed as defined by CTCAE, Version 4.0.
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4.2.2
Rationale for the Use of Comparator/Placebo
The use of a placebo for olaparib will ensure the objectivity of Investigator-assessed 
progression, as well as any decisions to interrupt/discontinue therapy.
Note: The study has been unblinded. Participants who are confirmed to be actively taking 
placebo should discontinue taking the placebo intervention and continue in the study. 
Participants taking Olaparib should continue receiving it per Investigator’s discretion after 
discussion.
4.3
Justification for Dose
4.3.1
Starting Dose for Olaparib
The safety and efficacy of olaparib have been demonstrated in the clinical programs using
predominantly the capsule formulation (400 mg [8 capsules] twice daily); however, an 
improved tablet formulation (2 tablets twice daily) has been developed and will be used in 
this study. The recommended tablet formulation of olaparib as monotherapy is 300 mg twice 
daily, which is considered similar in terms of efficacy and safety to the capsule 400 mg twice 
daily dose. 
 
 
 The tolerability profile 
of the 300 mg BID tablet dose in Study 24 was considered similar to the 400 mg BID capsule 
formulation. The most common AEs were consistent with the known safety profile of 
olaparib, namely low-grade nausea, vomiting, fatigue, and anemia. The tablet formulation is 
used across the olaparib Phase III program. 
Olaparib, when given via the tablet formulation has a tmax typically between 0.5 and 2 hours 
and mean terminal half-life of approximately 12 to 15 hours. Based on the average single 
dose t½, it would be expected that steady state exposure would be achieved within 
approximately 3 days of commencing dosing with olaparib. It is metabolized primarily by the 
CYP3A4 enzyme and is excreted through the urine (35% to 50%) and feces (12% to 60%).
Further information is provided in the olaparib Investigator’s Brochure.
4.3.2
Starting Dose for Pembrolizumab
The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based 
on the totality of data generated in the Keytruda development program, 200 mg Q3W is the 
appropriate dose of pembrolizumab for adults across all indications and regardless of tumor 
type. As outlined below, this dose is justified by: 
•
Clinical data from 8 randomized studies demonstrating flat dose- and exposure-efficacy 
relationships from 2 mg/kg Q3W to 10 mg/kg every 2 weeks (Q2W),
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•
Clinical data showing meaningful improvement in benefit-risk including overall survival 
at 200 mg Q3W across multiple indications, and
•
Pharmacology data showing full target saturation in both systemic circulation (inferred 
from pharmacokinetic [PK] data) and tumor (inferred from physiologically based PK 
[PBPK] analysis) at 200 mg Q3W. 
Among the 8 randomized dose-comparison studies, a total of 2262 participants were enrolled 
with melanoma and NSCLC, covering different disease settings (treatment-naïve, previously 
treated, PD-L1 enriched, and all-comers) and different treatment settings (monotherapy and 
in combination with chemotherapy). Five studies compared 2 mg/kg Q3W versus 10 mg/kg 
Q3W (KN001 Cohort B2, KN001 Cohort D, KN002, KN010, and KN021), and 3 studies 
compared 10 mg/kg Q3W versus 10 mg/kg Q2W (KN001 Cohort B3, KN001 Cohort F2, and 
KN006). All of these studies demonstrated flat dose- and exposure-response relationships 
across the doses studied representing an approximate 5- to 7.5- fold difference in exposure. 
The 2 mg/kg (or 200 mg fixed dose) Q3W provided similar responses to the highest doses 
studied. Subsequently, flat dose-exposure-response relationships were also observed in other 
tumor types including head and neck cancer, bladder cancer, gastric cancer and classical 
Hodgkin Lymphoma, confirming 200 mg Q3W as the appropriate dose independent of the 
tumor type. These findings are consistent with the mechanism of action of pembrolizumab, 
which acts by interaction with immune cells, and not via direct binding to cancer cells. 
Additionally, pharmacology data clearly show target saturation at 200 mg Q3W. First, PK 
data in KN001 evaluating target-mediated drug disposition (TMDD) conclusively 
demonstrated saturation of PD-1 in systemic circulation at doses much lower than 200 mg 
Q3W. Second, a PBPK analysis was conducted to predict tumor PD-1 saturation over a wide 
range of tumor penetration and PD-1 expression. This evaluation concluded that 
pembrolizumab at 200 mg Q3W achieves full PD-1 saturation in both blood and tumor. 
Finally, population PK analysis of pembrolizumab, which characterized the influence of 
body weight and other participant covariates on exposure, has shown that the fixed-dosing 
provides similar control of PK variability as weight-based dosing, with considerable overlap 
in the distribution of exposures from the 200 mg Q3W fixed dose and 2 mg/kg Q3W dose. 
Supported by these PK characteristics and given that fixed dose has advantages of reduced 
dosing complexity and reduced potential of dosing errors, the 200 mg Q3W fixed dose was 
selected for evaluation across all pembrolizumab protocols. 
4.3.2.1
Rationale for Carboplatin With Paclitaxel/nab-Paclitaxel Dosing Regimen
The platinum doublet (carboplatin with paclitaxel or nab-paclitaxel) used in this study is a
well-established regimen for squamous NSCLC. 
4.3.3
Maximum Dose/Exposure for This Study
4.3.3.1
Pembrolizumab
The maximum duration of exposure for pembrolizumab is 35 administrations (~2 years).
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4.3.3.2
Olaparib
There is no maximum duration of exposure for olaparib.
4.4
Beginning and End of Study Definition
The overall study begins when the first participant (or their legally acceptable representative) 
provides documented informed consent. The overall study ends when the last participant 
completes the last study-related contact, withdraws consent, or is lost to follow-up (ie, the 
participant is unable to be contacted by the investigator).
Upon study completion, participants are discontinued and may be enrolled in a 
pembrolizumab extension study, if available.
4.4.1
Clinical Criteria for Early Study Termination
The clinical study may be terminated early if the extent (incidence and/or severity) of 
emerging effects/clinical endpoints is such that the risk/benefit ratio to the study population 
as a whole is unacceptable. In addition, further recruitment in the study or at particular study 
sites may be stopped due to insufficient compliance with the protocol, Good Clinical Practice 
(GCP), and/or other applicable regulatory requirements, procedure-related problems, or an 
unacceptably high number of discontinuations or withdrawals due to administrative reasons.
5
STUDY POPULATION
Male and female participants with untreated Stage IV squamous NSCLC will be enrolled in 
this study.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
5.1
Inclusion Criteria
To be eligible for inclusion in this study, the participant must:
Type of Participant and Disease Characteristics
1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC. Patients 
with mixed histology (eg, adenosquamous) are allowed if there is squamous component 
in the specimen.
2. Have Stage IV (T any, N any, M1a, M1b, or M1c as per AJCC 8th edition) squamous 
NSCLC.
3. Have measurable disease based on RECIST 1.1, as determined by the local site 
investigator/radiology assessment. Target lesions situated in a previously irradiated area 
are considered measurable if progression has been demonstrated in such lesions.
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4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. 
Participants who received adjuvant or neoadjuvant therapy are eligible if the 
adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development 
of metastatic disease.
5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy 
of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) 
tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived 
tissue.
Note: Details pertaining to tumor tissue submission can be found in the Procedures 
Manual.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the 
central laboratory before the participant can start the Induction Phase. Submission of 
another tumor specimen may be required prior to enrolling the participant, if adequate 
tumor tissue was not provided the first time. 
6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group 
(ECOG) Performance Status assessed within 7 days prior to the administration of study 
intervention.
7. Have a life expectancy of at least 3 months. 
8. Has adequate organ function, as detailed in Table 3; all screening laboratory tests should 
be performed within 10 days prior to initiation of study treatment.
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Table 3
Adequate Organ Function Laboratory Values
System
Laboratory Value
Hematological
Absolute neutrophil count (ANC)
≥1500 cells/µL
Platelets
≥100 000 cells/µL
Hemoglobin
≥9.0 g/dL1
Renal
Estimated creatinine clearance using the Cockcroft-
Gault equation test2 or a 24-hour urine test
>51 mL/min 
Hepatic
Total bilirubin
≤1.5 × ULN OR direct bilirubin ≤ULN for 
participants with total bilirubin levels >1.5 × ULN
AST (SGOT) and ALT (SGPT)
≤2.5 × ULN (≤5 × ULN for participants with liver 
metastases)
Coagulation (only required at Screening)
International normalized ratio (INR) OR 
prothrombin time (PT)
Activated partial thromboplastin time (aPTT)
≤1.5 × ULN unless participant is receiving 
anticoagulant therapy as long as PT or aPTT is 
within therapeutic range of intended use of 
anticoagulants
Abbreviations: ALT (SGPT)=alanine aminotransferase (serum glutamic-pyruvic transaminase); 
aPTT=Activated partial thromboplastin time; AST (SGOT)=aspartate aminotransferase (serum glutamic-
oxaloacetic transaminase); ANC=Absolute neutrophil count; CrCl=creatinine clearance; GFR=glomerular 
filtration rate; INR=international normalized ratio; PT=prothrombin time; ULN=upper limit of normal.
1. For Screening, criteria must be met without erythropoietin dependency and without packed red blood cell 
(pRBC) transfusion within last 28 days prior to initiation of study intervention. For post-Induction/pre-
Randomization, criteria must be met without erythropoietin dependency within last 14 days prior to 
randomization.
2. Estimated creatinine clearance using Cockcroft-Gault:
(140-age [years] × weight (kg)
(×F)*
Serum creatinine (mg/dL) × 72
*where F = 0.85 for females and F = 1 for males
As an alternative, the creatinine clearance can be determined from a 24-hour urine collection.
Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value 
requirements should be adapted according to local regulations and guidelines for the administration of 
specific chemotherapies.
Demographics
9. Be at least 18 years of age on day of signing informed consent.
Male Participants
10. Male participants are eligible to participate if they agree to the following during the 
intervention period for at least 180 days after the last dose of study intervention:
•
Refrain from donating sperm
•
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle 
(abstinent on a long-term and persistent basis) and agree to remain abstinent
OR
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•
Agree to use contraception, unless confirmed to be azoospermic (vasectomized or 
secondary to medical cause [Appendix 5]), as detailed below:
•
Agree to use male condom plus partner use of an additional contraceptive method 
when having penile-vaginal intercourse with a woman of childbearing potential 
(WOCBP) who is not currently pregnant. 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-vaginal penetration.
Contraceptive use by men should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies. If the contraception 
requirements in the local label for any of the study interventions is more stringent than 
the requirements above, the local label requirements are to be followed.
Female Participants
11. A female participant is eligible to participate if she is not pregnant (Appendix 5), not 
breastfeeding, and at least 1 of the following conditions applies:
a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5.
OR
b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the 
treatment period and for at least 180 days following the last dose of pembrolizumab 
and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy
and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use 
for the purpose of reproduction during this period. The investigator should evaluate 
the potential for contraceptive method failure (ie, noncompliance, recently initiated) 
in relationship to the first dose of study intervention.

A WOCBP must have a negative highly sensitive urine pregnancy test as required by 
local regulations) within 24 hours (72 hours for serum) before the first dose of study 
intervention.

Additional requirements for pregnancy testing during and after study intervention are 
in Appendix 5.

The investigator is responsible for review of medical history, menstrual history, and 
recent sexual activity to decrease the risk for inclusion of a woman with an early 
undetected pregnancy.
Contraceptive use by women should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies. If the contraception
requirements in the local label for any of the study interventions is more stringent than 
the requirements above, the local label requirements are to be followed.
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Informed Consent
12. Has (or legally acceptable representative) provided documented informed consent/assent 
for the study. The participant may also provide consent/assent for Future Biomedical 
Research. However, the participant may participate in the main trial without participating 
in Future Biomedical Research.
Additional Criteria Applicable to Maintenance Phase Only - Prior to Randomization
13. Has a CR/PR or stable disease of their NSCLC as determined by central imaging review 
after completion of study-specified Induction Phase.
14. Have an ECOG performance status score of 0 or 1 as assessed at Pre-randomization visit
(most recent assessment within this visit).
15. All AEs (with the exception of alopecia, Grade 2 fatigue, and Grade ≤2 endocrine-related 
AEs requiring treatment or hormone replacement. For anemia and creatinine clearance,
the guidelines provided in Table 3 may be followed) resolved to Grade ≤1 or baseline 
following Induction Phase treatment.
16. Have adequate organ function, as indicated by the laboratory values in Table 3 above.
17. Are not taking medications or vaccinations specifically prohibited in the Exclusion 
Criteria (Section 5.2).
18. Are not pregnant or breastfeeding or expecting to conceive or father children within the 
projected duration of the study, starting from the pre-randomization visit through 
180 days after the last dose of study intervention.
19. Have not withdrawn consent to continue treatment.
20. Continue to derive clinical benefit from study participation according to investigator’s 
discretion.
5.2
Exclusion Criteria
The participant must be excluded from the study if the participant:
Medical Conditions
1. Has non-squamous histology NSCLC. Mixed tumors will be categorized by the 
predominant cell type; if small cell elements are present, the participant is ineligible; for 
non-small cell histology if there is any squamous element is present (example 
adenosquamous), the participant is eligible; the squamous element does not have to be 
predominant.
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2. Has a known additional malignancy that is progressing or has progressed within the past 
3 years requiring active treatment. 
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the 
skin or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have 
undergone potentially curative therapy are not excluded.
3. Has known active central nervous system metastases and/or carcinomatous meningitis.
Participants with previously treated brain metastases may participate provided they are 
clinically stable for at least 2 weeks and, have no evidence of new or enlarging brain 
metastases and also are off steroids 3 days prior to dosing with study medication. Stable 
brain metastases by this definition should be established prior to the first dose of study 
medication. Participants with known untreated, asymptomatic brain metastases (ie, no 
neurological symptoms, no requirements for corticosteroids, no or minimal surrounding 
edema, and no lesion >1.5 cm) may participate, but will require regular imaging of the 
brain as a site of disease.
4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel 
or nab-paclitaxel, or olaparib.
5. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
6. 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, etc.) is not considered a form of systemic 
treatment.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in 
dosing exceeding 10 mg daily of prednisone equivalent) or any other form of 
immunosuppressive therapy within 7 days prior the first dose of study intervention.
8. Has a history of (non-infectious) pneumonitis that required steroids or has current 
pneumonitis.
9. Has an active infection, requiring systemic therapy.
10. Has known history of human immunodeficiency virus (HIV) infection. No HIV testing is 
required unless mandated by local health authority.
11. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] 
reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is 
detected) infection. 
Note: No testing for Hepatitis B or Hepatitis C is required unless mandated by local 
health authority.
12. Participant has a known history of active tuberculosis (TB, Mycobacterium tuberculosis).
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13. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is 
not exclusionary.
14. Has symptomatic ascites or pleural effusion. A participant who is clinically stable 
following treatment for these conditions (including therapeutic thoraco- or paracentesis) 
is eligible.
15. Has a known psychiatric or substance abuse disorder that would interfere with the 
participant’s ability to cooperate with the requirements of the study.
16. Is pregnant or breastfeeding, or expecting to conceive or father children within the 
projected duration of the study, starting with the screening visit through 180 days after 
the last dose of study intervention.
17. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features 
suggestive of MDS/AML.
18. Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor 
[G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant 
erythropoietin) within 28 days prior to the first dose of study intervention. Note: For post-
Induction/pre-Randomization, within 14 days prior to randomization.
19. Is considered a poor medical risk in the opinion of the treating Investigator due to a 
serious, uncontrolled medical disorder or non-malignant systemic disease. Examples 
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 
3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal 
cord compression, or superior vena cava syndrome.
20. Is unable to swallow orally administered medication or has a gastrointestinal disorder 
affecting absorption (eg, gastrectomy, partial bowel obstruction, malabsorption).
Prior/Concomitant Therapy
21. Has received prior therapy with olaparib or with any other PARP inhibitor.
22. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an 
agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, 
OX-40, CD137).
23. Before the first dose of study treatment:
a) Has received prior systemic cytotoxic chemotherapy for metastatic disease
b) Has received other targeted or biological antineoplastic therapy (eg, erlotinib, 
crizotinib, cetuximab) for metastatic disease
c) Had major surgery (<3 weeks prior to study intervention) or has not recovered 
from any effects of any major surgery.
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24. Received radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of 
trial treatment.
25. Completed palliative radiotherapy within 7 days of the first dose of trial treatment. 
Participants must have recovered from all radiation-related toxicities and not require 
corticosteroids
26. Is expected to require any other form of antineoplastic therapy while on study
27. Has received a live or live attenuated vaccine within 30 days prior to the first dose of 
study drug. Note: Killed vaccines are allowed.
28. Is currently receiving either strong (eg, itraconazole, telithromycin, clarithromycin, 
protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, 
boceprevir, telaprevir) or moderate (eg, ciprofloxacin, erythromycin, diltiazem, 
fluconazole, verapamil) inhibitors of cytochrome P450 (CYP)3A4 that cannot be 
discontinued for the duration of the study. The required washout period prior to starting 
olaparib is 2 weeks.
Note: a current list of strong/moderate inhibitors of CYP3A4 can be found at the 
following website:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugI
nteractionsLabeling/ucm093664.htm
29. Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, 
rifabutin, rifapentine, carbamazepine, nevirapine and St John’s Wort) or moderate (eg, 
bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the 
duration of the study. The required washout period prior to starting olaparib is 5 weeks 
for phenobarbital and 3 weeks for other agents.
Note: a current list of strong/moderate inducers of CYP3A4 can be found at the following 
website:  
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugI
nteractionsLabeling/ucm093664.htm
Prior/Concurrent Clinical Study Experience
30. Is currently participating in or has participated in a study of an investigational agent or 
has used an investigational device within 4 weeks prior to the first dose of study 
intervention.
Note: Participants who have entered the follow-up phase of an investigational study may 
participate as long as it has been 4 weeks after the last dose of the previous 
investigational agent
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Diagnostic Assessments
31. The presence of uncontrolled, potentially reversible cardiac conditions, as judged by the 
Investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive 
heart failure, electrolyte disturbances, etc.), or participant has congenital long QT 
syndrome.
Other Exclusions
32. Has had an allogeneic tissue/solid organ transplant.
5.3
Lifestyle Considerations
5.3.1
Meals and Dietary Restrictions
During the Maintenance Phase, participants should avoid grapefruit, grapefruit juice, and St. 
John’s Wort (tablet or tea) while receiving study intervention. Otherwise, participants should 
maintain a normal diet unless modifications are required to manage AEs such as diarrhea, 
nausea, or vomiting.
5.3.2
Contraception
The study intervention may have adverse effects on a fetus in utero. Refer to Appendix 5 for 
approved methods of contraception.
Participants should be informed that taking the study intervention may involve unknown 
risks to the fetus (unborn baby) if pregnancy were to occur during the trial. To participate in 
the trial, participants of childbearing potential must adhere to the contraception requirement 
(Appendix 5) from the day of study intervention initiation (or 14 days prior to the initiation 
of study intervention for oral contraception) throughout the trial period up to 180 days after 
the last dose of study intervention. If there is any question that a participant of childbearing 
potential will not reliably comply with the requirements for contraception, that participant 
should not be entered into the study.
5.3.3
Pregnancy
If a participant inadvertently becomes pregnant during the study, the participant will be 
immediately discontinued from study intervention. The site will contact the participant at 
least monthly and document the participant’s status until the pregnancy has been completed 
or terminated. The outcome of the pregnancy will be reported to the Sponsor as described in 
Section 8.4.5.
5.3.4
Use in Nursing Women
It is unknown whether any of the study medications are 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 breastfeeding are not eligible for enrollment.
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5.3.5
Activity Restrictions
Adverse events related to olaparib may include asthenia, fatigue, and dizziness. Therefore, 
participants should be advised to use caution while driving or using machinery if these 
symptoms occur. 
5.4
Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study, but 
are not subsequently enrolled in the study. A minimal set of screen failure information is 
required to ensure transparent reporting of screen failure participants to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to 
respond to queries from regulatory authorities. Minimal information includes demography, 
screen failure details, eligibility criteria, and any AEs or SAEs meeting reporting 
requirements as outlined in the data entry guidelines.
5.5
Participant Replacement Strategy
A participant who discontinues from study intervention OR withdraws will not be replaced.
6
STUDY INTERVENTION
Study intervention is defined as any investigational intervention(s), marketed product(s), 
placebo, or medical device(s) intended to be administered to a study participant according to 
the study protocol.
Clinical supplies will be packaged to support enrollment as required. Clinical supplies will be 
affixed with a clinical label in accordance with regulatory requirements.
6.1
Study Intervention(s) Administered
The study intervention(s) to be used in this study are outlined in Table 4.
In the Induction Phase, pembrolizumab should be given prior to chemotherapy; carboplatin 
and either paclitaxel or nab-paclitaxel should be given as per SOC. 
For the Maintenance Phase, Olaparib on Day 1 should be given prior to pembrolizumab.
Note: Based on the data from an interim safety and efficacy analysis (IA3), the external Data 
Monitoring Committee recommended to remove the final analysis. Participants will be 
unblinded. Participants who are confirmed to be actively taking placebo should discontinue 
taking the placebo intervention and continue in the study. Participants taking Olaparib should 
continue receiving it per the investigator’s discretion after discussion. Participants currently 
undergoing or who will undergo Second Course with pembrolizumab monotherapy can 
continue or start treatment per investigator’s discretion under this protocol or under an 
extension study. Participants who are potential candidates for Second Course treatment will 
continue in Efficacy Follow-up. 
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Table 4
Study Interventions
Drug Name
Drug Type
Intervention 
Name
Type
Dose 
Formulation
Unit Dose 
Strength(s)
Dosage 
Level(s)
Route of 
Administration
Regimen/
Treatment 
Period/Vaccination 
Regimen
Use
IMP/
NIMP
Sourcing
Pembrolizumab
Experimental
Active
Drug
Solution 
for 
Infusion
25 mg/mL
200 mg
IV Infusion
Q3W/Induction and 
Maintenance Phases 
for a maximum of 
35 cycles
Experi-
mental
IMP
Central
Carboplatin
Other
Chemo-
therapy
Drug
Solution 
for 
Infusion
10 mg/mL 
(60 mL)
AUC 
6 mg/mL/min
IV Infusion
Q3W/Induction 
Phase (4 cycles)
SOC
NIMP
Local or 
Central
Paclitaxel
Other
Chemo-
therapy
Drug
Solution 
for 
Infusion
6 mg/mL 
(16.7 mL)
200 mg/m2
IV Infusion
Q3W/Induction 
Phase (4 cycles)
SOC
NIMP
Local or 
Central
Nab-paclitaxel
Other
Chemo-
therapy
Drug
Solution 
for 
Infusion
5 mg/mL
100 mg/m2
IV Infusion
Q3W/Induction 
Phase (Days 1,8 and 
15 for 4 cycles)
SOC
NIMP
Local or 
Central
Olaparib
Experimental
Active
Drug
Tablet
150 mg; 
100 mg
300 mg
Oral
BID/Maintenance 
Phase
Experi-
mental
IMP
Central
Placebo
Control
Placebo
Other
Tablet
150 mg; 
100 mg
N/A
Oral
BID/Maintenance 
Phase
Placebo
IMP
Central
Abbreviations: AUC=area under the plasma drug concentration time curve; BID=twice daily; IMP=Investigational Medicinal Product; IV=intravenous; N/A=not applicable; 
NIMP=Non-investigational Medicinal Product; Q3W=every 3 weeks; SOC=standard of care.
Note: Definition Investigational Medicinal Product (IMP) and Non-Investigational Medicinal Product (NIMP) is based on guidance issued by the European Commission. Regional 
and/or Country differences of the definition of IMP/NIMP may exist. In these circumstances, local legislation is followed.
Note: For locally sourced supplies, the unit dose strength may vary, depending on market availability.
Note: The Olaparib 300-mg dose should be made up of 2 × 150 mg tablets; 100 mg tablets and matching placebo are provided for dose reductions as outlined in Section 6.6.1.
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Placebo for Olaparib was created to match the active product.
All supplies indicated in Table 4 will be provided per the "Sourcing" column depending upon 
local country operational requirements. If local sourcing, every attempt should be made to 
source these supplies from a single lot/batch number where possible (eg, not applicable in the 
case where multiple lots or batches may be required due to the length of the study, etc.).
Refer to Section 8.1.8 for details regarding administration of the study intervention.
6.2
Preparation/Handling/Storage/Accountability
6.2.1
Dose Preparation
The Pembrolizumab Pharmacy Manual contains specific instructions for pembrolizumab 
preparation and administration. 
Olaparib and Olaparib placebo are tablets for oral administration; no preparation is required
(see Olaparib Pharmacy Manual). Olaparib and matching placebo will be provided in high-
density polyethylene (HDPE) bottles with child-resistant closures. Each bottle will be labeled
in accordance with Good Manufacturing Practice (GMP) Annex 13 and per country 
regulatory requirement.
Carboplatin and paclitaxel/nab-paclitaxel should be prepared per local and institutional 
guidelines according to the approved product labels.
The rationale for selection of doses to be used in this study is provided in Section 4.3.
6.2.2
Handling, Storage, and Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received, and any discrepancies are 
reported and resolved before use of the study intervention.
Only participants enrolled in the study may receive study intervention, and only authorized 
site staff may supply or administer study intervention. All study interventions 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, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records).
For all study sites, the local country Sponsor personnel or designee will provide appropriate 
documentation that must be completed for drug accountability and return, or local discard 
and destruction if appropriate. Where local discard and destruction is appropriate, the 
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investigator is responsible for ensuring that a local discard/destruction procedure is 
documented.
The study site is responsible for recording the lot number, manufacturer, and expiry date for 
any locally purchased product (if applicable) as per local guidelines unless otherwise 
instructed by the Sponsor.
The investigator shall take responsibility for and shall take all steps to maintain appropriate 
records and ensure appropriate supply, storage, handling, distribution, and usage of study 
interventions in accordance with the protocol and any applicable laws and regulations.
6.3
Measures to Minimize Bias: Randomization and Blinding
6.3.1
Intervention Assignment
Treatment allocation will occur centrally using an interactive response technology (IRT) 
system. The allocation numbers will be given to each participant at the time of 
randomization.
There are 2 study intervention arms. Participants will be assigned randomly in a 1:1 ratio to 
receive either pembrolizumab plus olaparib or pembrolizumab plus placebo.
Randomization will occur after participants complete the Induction Phase and imaging shows 
SD, PR, or CR, as verified by central vendor. All participants will undergo a pre-
randomization visit during which a checklist will be completed by the investigator and 
approved by the Sponsor. Randomization will be done via the IRT system.
CCI
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6.3.3
Blinding
The Induction Phase of this study is conducted as open-label; therefore, the Sponsor, 
investigator, and participant will know the intervention administered. 
The Maintenance Phase of this study will make use of a double-blinding technique and in-
house blinding will be used. Olaparib and its placebo will be packaged identically so that the 
blind is maintained. The participant, the investigator, and Sponsor personnel or delegates 
who are involved in the study intervention administration or clinical evaluation of the 
participants are unaware of the intervention assignments.
Note: Based on the IA3 data, the study was unblinded on 15-DEC-2023.
6.4
Study Intervention Compliance
6.4.1
Olaparib Compliance
Note: As of Amendment 07, participants who are confirmed to be actively taking placebo 
should discontinue taking the placebo intervention and continue in the study. The protocol 
content has been retained for reference.
Participants will take their dose of olaparib/olaparib placebo BID without regard to food. 
Participants will self-administer olaparib/olaparib placebo except on Day 1 of the first cycle, 
when the dose will be given at the study site clinic prior to the infusion of pembrolizumab.
For all other cycles, olaparib will be given prior to pembrolizumab infusion.
Site staff will make tablet counts at regular intervals during treatment. After the tablet count 
has been performed, the remaining tablets will not be returned to the participant, but will be 
retained by the investigative site until reconciliation is completed by the study monitor. 
Olaparib/olaparib placebo compliance will be calculated by the Sponsor based on the drug 
accountability documented by the site staff and monitored by the Sponsor/designee. All 
participants will be instructed to return their bottle of olaparib or olaparib placebo at the 
appropriate scheduled visit, when a new bottle will be dispensed. Participants will be 
instructed to notify study site personnel of missed doses.
Interruptions from the protocol-specified olaparib/olaparib placebo treatment plan for >21
consecutive days require consultation between the investigator and the Sponsor and written 
documentation of the collaborative decision on participant management.
6.4.2
Pembrolizumab and Chemotherapy Compliance
Pembrolizumab and chemotherapy will be administered on an out-patient basis.
Interruptions from either the protocol-specified pembrolizumab or chemotherapy 
(carboplatin, paclitaxel or nab-paclitaxel) treatment plan require consultation between the 
investigator and the Sponsor and written documentation of the collaborative decision on 
participant management (Section 7.1).
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If there are interruptions in the study intervention schedule or injection was stopped, the 
details of reason for any interruption or infusion cessation of study intervention will be 
documented in the participant’s medical record.
Refer to Section 6.6.3 for dose modification and toxicity management for irAEs associated 
with pembrolizumab and for other allowed dose interruption of pembrolizumab.
6.5
Concomitant Therapy
All concomitant medications received within 28 days prior to the first dose of study 
intervention and up to 30 days after the last dose of study intervention should be recorded. If 
participants experience an SAE or ECI, all concomitant medications administered >30 days 
after the last dose of study intervention are to be recorded as defined in Section 8.4.7.
Based on in vitro data, olaparib may increase the exposure to substrates of CYP3A4, organic-
anion-transporting polypeptide (OATP)1B1, organic cation transporter (OCT)1/2/3, and 
multidrug and toxic compound extrusion (MATE)1/2 and reduce exposure to substrates of 
CYP2B6. Caution should be observed if substrates of these isoenzymes or transporter 
proteins are co-administered. A current list of substrates can be found at the following 
website:
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInter
actionsLabeling/ucm093664.htm
All treatments that the Investigator considers necessary for a participant’s welfare may be 
administered at the discretion of the Investigator in keeping with the community standards of 
medical care. All concomitant medication will be recorded on the electronic case report form 
(eCRF) including all prescription, over-the-counter (OTC) products, herbal supplements, and 
IV medications and fluids. If changes occur during the study period, documentation of drug 
dosage, frequency, route, and date should also be included on the eCRF.
6.5.1
Prohibited Concomitant Medications
Medications or vaccinations specifically prohibited in the exclusion criteria (Section 5.2) are 
not allowed during Screening Phase and administration of study intervention. If there is a 
clinical indication for any medication or vaccination specifically prohibited, discontinuation 
from study intervention may be required. The investigator should discuss any questions 
regarding this with the Sponsor Clinical Director. The final decision on any supportive 
therapy or vaccination rests with the investigator and/or the participant’s primary physician;
however, the decision to continue the participant on study intervention requires the mutual 
agreement of the investigator, the Sponsor, and the participant.
Listed below are specific concomitant therapies or vaccinations that are prohibited during the 
study (exceptions noted):
1. Antineoplastic systemic chemotherapy, immunotherapy, or biological therapy not 
specified in this protocol.
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2. Investigational agents other than pembrolizumab and olaparib.
3. Surgery for tumor control.
4. Radiation therapy for disease control.
•
Note: Participants are allowed to receive palliative radiotherapy for painful bone 
lesions. Targeted external beam irradiation should not be used in the primary lung 
field where assessment for tumor is indicated. Radiation therapy to the brain may be 
allowed following Sponsor consultation. 
5. Live or live attenuated vaccines while participating in the trial, and within 30 days of 
the last dose of study intervention. See Appendix 7 for country-specific requirements.
•
Note: killed vaccines are allowed
•
Note: Any licensed COVID-19 vaccine (including for Emergency Use) in a particular 
country is allowed in the study as long as they are mRNA vaccines, adenoviral 
vaccines, or inactivated vaccines. These vaccines will be treated just as any other 
concomitant therapy.
Investigational vaccines (ie, those not licensed or approved for Emergency Use) are 
not allowed.
6. Anticancer hormonal therapy (eg, androgen deprivation, androgen receptor blockade, 
anti-estrogens)
•
Note: Hormonal replacement therapy (eg, thyroxine, insulin, or physiologic 
corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
7. Strong and moderate inducers or inhibitors of CYP3A4 that cannot be discontinued for 
the duration of the study.
•
Note: a current list of strong/moderate inducers/inhibitors of CYP3A4 can be found 
at the following website:  
https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/D
rugInteractionsLabeling/ucm093664.htm
•
Note: Exceptions are outlined in Section 6.6.2.5.
•
Note: Only applicable to participants taking Olaparib concomitantly.
8. Systemic glucocorticoids are permitted for the following purposes:
•
To modulate symptoms of an AE that is suspected to have an immunologic etiology
•
As needed for the prevention of emesis 
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•
Premedication for IV contrast allergies
•
Short-term oral or IV use in doses >10 mg/day prednisone equivalent for COPD 
exacerbations
•
For chronic systemic replacement not to exceed 10 mg/day prednisone equivalent 
In addition, the following glucocorticoid use is allowed:
•
For topical use or ocular use
•
Intraarticular joint use
•
For inhalation in the management of asthma or chronic obstructive pulmonary disease
9. Phenytoin during therapy with carboplatin.
In addition to the medications listed here, study site staff should refer to the approval product 
labels for prohibited medications, as well as drug-drug interactions for each 
chemotherapeutic agent used in this study.
If the investigator determines that a participant requires any of the aforementioned treatments 
for any reason, all study intervention must be discontinued.
There are no prohibited therapies during the Long-term Follow-up Phase.
6.5.2
Rescue Medications and Supportive Care
Participants should receive appropriate supportive care measures as deemed necessary by the 
treating Investigator. Suggested supportive care measures for the management of AEs with 
potential immunologic etiology are outlined along with the dose modification guidelines in 
Section 6.6.3, Table 9. Where appropriate, these guidelines include the use of oral or IV 
treatment with corticosteroids, as well as additional anti-inflammatory agents if symptoms do 
not improve with administration of corticosteroids. Note that several courses of steroid 
tapering may be necessary as symptoms may worsen when the steroid dose is decreased. For 
each disorder, attempts should be made to rule out other causes such as metastatic disease or 
bacterial or viral infection, which might require additional supportive care. The treatment 
guidelines are intended to be applied when the investigator determines the events to be 
related to pembrolizumab.
Note: If after the evaluation of the event, it is determined not to be related to pembrolizumab, 
the investigator does not need to follow the treatment guidance. Refer to Table 9 in 
Section 6.6.3 for guidelines regarding dose modification and supportive care.
Participants should receive appropriate supportive care measures as deemed necessary by the 
treating Investigator.
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It may be necessary to perform conditional procedures such as bronchoscopy, endoscopy, or 
skin photography as part of evaluation of the event.
6.6
Dose Modification (Escalation/Titration/Other)
Note: As of Amendment 07, participants will be unblinded. Participants who are confirmed 
to be actively taking placebo should discontinue taking the placebo intervention and continue 
in the study. Participants taking Olaparib should continue receiving it per investigator’s 
discretion after discussion. Participants who are potential candidates for Second Course 
treatment will continue in Efficacy Follow-up. Participants currently undergoing or who will 
undergo Second Course with pembrolizumab monotherapy can continue or start treatment 
per investigator’s discretion under this protocol or under an extension study.
6.6.1
Management of Overlapping Toxicities of Olaparib and Pembrolizumab
Both olaparib and pembrolizumab treatment may be associated with the development of 
pneumonitis and renal toxicity. 
For renal dysfunction, follow the dose modification guidelines provided in Table 7
(Olaparib) and Table 9 (pembrolizumab). A kidney biopsy is strongly recommended to help 
to determine etiology of renal dysfunction.
If pneumonitis is confirmed, treatment with olaparib/olaparib placebo must be withheld. 
Olaparib/olaparib placebo may be restarted once pneumonitis has completely resolved. 
Treatment with pembrolizumab must be withheld for pneumonitis ≥Grade 2 (Table 9). When 
the pneumonitis resolves to <Grade 2, then pembrolizumab may be resumed as per guidelines 
in Table 9. Sponsor consultation is recommended if there are any doubts. Study intervention 
must be discontinued for recurrent Grade 2 pneumonitis (Section 7.1).
6.6.2
Olaparib Dose Modifications
The dose of olaparib can be reduced to 250 mg BID initially and then to 200 mg BID as 
needed. If the 200 mg BID dose is not tolerable, no further dose reduction is allowed and 
study intervention should be discontinued. Once the dose has been reduced, escalation is not 
permitted.
The reason for the dose interruption or reduction should be captured on the appropriate 
eCRF.
During the Maintenance Phase, if, in the opinion of the investigator, a toxicity is related to 
the combination of both olaparib and pembrolizumab, both drugs should be interrupted 
and/or discontinued according to the recommendations listed in this section. If the toxicity 
can be attributable to olaparib or pembrolizumab, the respective agent may be reduced (if 
applicable), interrupted, or discontinued according to the recommendations listed in this 
section; in such situations, the other agent can continue to be administered.
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6.6.2.1
Management of Hematological Toxicities
Any hematological toxicity observed during the study could be managed by a brief 
interruption of study intervention or a dose reduction of Olaparib (Table 5 and Table 6). 
Repeated interruptions, not exceeding 3 weeks (21 days) duration, are allowed as required. If 
the interruption is any longer, the Sponsor must be informed.
Table 5
Management of Anemia
Toxicity
NCI CTCAE Grade
Action Taken
Hemoglobin (Hb)
Grade 2
(<9.0 but ≥8.0 g/dL)
First Occurrence:
Give appropriate supportive treatment and investigate 
causality.

Investigator judgment to either continue maintenance 
olaparib with supportive treatment (eg, transfusion) 
or interrupt maintenance olaparib dosing for a 
maximum of 3 weeks (21 days). Study intervention
can be restarted if Hb has recovered to >9.0 g/dL.
Subsequent Recurrence:

Hb <9.0 but ≥8.0 g/dL:  Interrupt maintenance
olaparib for a maximum of 3 weeks (21 days) until 
Hb improves to >9.0 g/dL. Upon recovery, reduce 
the dose of olaparib to 250 mg BID. A second dose 
reduction to 200 mg BID may be considered if 
additional decreases in Hb occur
Grade 3
(<8.0 g/dL)
Give appropriate supportive treatment (eg, transfusion) 
and investigate causality.

Interrupt olaparib, for a maximum of 3 weeks (21
days), until Hb improves to ≥9.0 g/dL.

Upon recovery, reduce the dose of maintenance 
olaparib to 250 mg BID. A second dose reduction to 
200 mg BID may be considered if additional 
decreases in Hb occur.
Abbreviations: BID=twice daily; CTCAE=Common Terminology Criteria for Adverse Events; 
Hb = hemoglobin; NCI = National Cancer Institute.
Note:  Common treatable causes of anemia (eg, iron, vitamin B12 or folate deficiencies and hypothyroidism) 
should be investigated and appropriately managed. In some cases, management of anemia may require blood 
transfusions. The management of prolonged hematological toxicities is detailed in Section 6.6.2.2.
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Table 6
Management of Neutropenia, Leukopenia, and Thrombocytopenia
Toxicity
NCI CTCAE Grade
Action Taken
Neutropenia, 
Leukopenia, or 
Thrombocytopenia
Grades 1 or 2
Investigator judgment to either continue maintenance 
olaparib or interrupt dosing for a maximum of 3 weeks 
(21 days). Give appropriate supportive treatment and 
investigate causality.
Grades 3 or 4

Interrupt olaparib, for a maximum of 3 weeks (21
days), until event recovers to ≤Grade 1.

Repeated incidence: reduce the dose of olaparib to 
250 mg BID. A second dose reduction to 200 mg 
BID may be considered if additional Grade 3 or 4 
events occur.

AEs of neutropenia and leukopenia should be managed as deemed appropriate by the investigator with 
close follow-up and interruption of study intervention if CTCAE Grade 3 or worse neutropenia occurs.

Primary prophylaxis with granulocyte colony-stimulating factor (G-CSF) is not recommended; however, 
if a participant develops febrile neutropenia, study intervention should be stopped and appropriate 
management including G-CSF should be given according to local hospital guidelines. Please note that 
G-CSF should not be used within at least 24 hours (7 days for pegylated G-CSF) of the last dose of study 
intervention unless absolutely necessary.

Platelet transfusions, if indicated, should be done according to local hospital guidelines. 

The management of prolonged hematological toxicities is detailed in Section 6.6.2.2.
6.6.2.2
Management of Prolonged Hematological Toxicities
If a participant develops prolonged hematological toxicity such as:
•
≥2-week interruption/delay in study intervention due to NCI CTCAE Grade 3 or worse 
anemia and/or the development of blood transfusion dependence
•
≥2-week interruption/delay in study intervention due to NCI CTCAE Grade 3 or worse 
neutropenia (ANC <1 × 109/L)
•
≥2-week interruption/delay in study intervention due to NCI CTCAE Grade 3 or worse 
thrombocytopenia and/or development of platelet transfusion dependence (platelets 
<50 × 109/L)
Differential blood count, including reticulocytes and peripheral blood smear, should be 
checked weekly. If any blood parameters remain clinically abnormal after the dosing of 
maintenance olaparib has been interrupted for ≥3 weeks (≥21 days), the participant should be 
referred to a hematologist for further investigations. Bone marrow analysis and/or blood 
cytogenetic analysis should be considered, according to local regulation and/or standard 
institutional hematological practice. Study intervention should be discontinued if blood 
counts do not recover to NCI CTCAE Grade 1 or better within 3 weeks (21 days) of dose 
interruption.
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Development of confirmed MDS or other clonal blood disorder should be reported as an SAE 
and full reports must be provided by the Investigator to the Sponsor as outlined in 
Section 8.4.4. Maintenance olaparib intervention should be discontinued for confirmed MDS 
and/or AML (Section 7.1).
6.6.2.3
Management of Nonhematologic Toxicity
Repeated dose interruptions, not exceeding 3 weeks (21 days) duration, are allowed as 
required. If toxicity reoccurs following rechallenge with study intervention, and where 
further dose interruptions are considered inadequate for management of toxicity, either a 
dose reduction should be considered (Section 6.6.1) or the participant must permanently 
discontinue study intervention.
Treatment must be interrupted if any NCI CTCAE Grade 3 or 4 AE occurs that the 
Investigator considers to be related to administration of olaparib.
6.6.2.3.1
Management of New or Worsening Pulmonary Symptoms
If new or worsening pulmonary symptoms (eg, dyspnea) or radiological abnormalities occur 
in the absence of a clear diagnosis, an interruption in study intervention dosing is 
recommended and further diagnostic workup (including a high resolution computed 
tomography [CT] scan) should be performed to exclude pneumonitis. Please refer to 
Table 9 as well, which outlines the Toxicity Management Guidelines for pembrolizumab as it 
can cause pneumonitis. 
Following investigation, if no evidence of abnormality is observed on CT imaging and 
symptoms resolve, then study intervention can be restarted, if deemed appropriate by the 
Investigator. If significant pulmonary abnormalities are identified, these need to be discussed 
with the Clinical Director. If pneumonitis is confirmed while on study, refer to Section 6.6.1 
for guidance on the management of olaparib and pembrolizumab.
6.6.2.3.2
Management of Nausea and Vomiting
Events of nausea and vomiting are known to be associated with maintenance olaparib. These 
events are generally mild to moderate (NCI CTCAE Grade 1 or 2) in severity, intermittent, 
and manageable on continued treatment. The first onset generally occurs in the first month of 
intervention for nausea and within the first 6 months of intervention for vomiting. For 
nausea, the incidence generally plateaus at approximately 9 months, and for vomiting at 
approximately 6 to 7 months.
No routine prophylactic antiemetic treatment is required at the start of study intervention; 
however, participants should receive appropriate antiemetic treatment at the first onset of 
nausea or vomiting and as required thereafter, in accordance with local regulations or 
institutional guidelines. Alternatively, olaparib tablets can be taken with a light meal/snack 
(ie, 2 pieces of toast or a couple of biscuits).
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As per international guidance on antiemetic use in cancer patients (ESMO, NCCN), generally 
a single agent antiemetic should be considered (eg, dopamine receptor antagonist, 
antihistamines).
6.6.2.3.3
Management of Renal Impairment
To initiate maintenance olaparib, creatinine clearance (CrCl) must be ≥51 mL/min.
If subsequent to study, entry and/or while still on study therapy, a participant’s estimated 
creatinine clearance (CrCl) falls below the threshold for study inclusion (≥51 ml/min), 
retesting should be performed promptly. 
A dose reduction is recommended for participants who develop moderate renal impairment 
(calculated CrCl between 31 to 50 mL/min as calculated by either Cockcroft-Gault equation 
or based on a 24 hour urine test) for any reason during the course of the study (Table 7).
Table 7
Dose Reduction of Olaparib to Manage Moderate Renal Impairment
Initial Dose
Moderate Renal Impairmenta
300 mg BID
200 mg BID
Abbreviation: BID = twice daily.
a.
Creatinine clearance of 31 to 50 mL/min as calculated by either Cockcroft-Gault equation. As an alternative, the 
creatinine clearance can be determined from a 24-hour urine collection.
Because the CrCl determination is only an estimate of renal function, in instances where the 
CrCl falls to between 31 to 50 mL/min, the Investigator should use his or her discretion in 
determining whether a dose change or discontinuation of therapy is warranted.
Please refer to Table 9, as well, which outlines the Toxicity Management Guidelines for 
pembrolizumab as it also can cause renal toxicity. For renal toxicity, a biopsy to determine 
the etiology of the toxicity and to determine if the renal toxicity is related to olaparib or 
pembrolizumab should be performed.
Olaparib has not been studied in participants with severe renal impairment (CrCl 
≤30 ml/min) or end-stage renal disease; if participants develop severe impairment or 
end-stage disease it is recommended that maintenance olaparib be discontinued.
6.6.2.4
Interruptions for Intercurrent Non-toxicity-related Events
Olaparib dose interruption for conditions other than toxicity resolution should be kept as 
short as possible. If a participant cannot restart study intervention within 3 weeks (21 days) 
for resolution of intercurrent conditions not related to disease progression or toxicity, the case 
should be discussed with the Clinical Director, and approved via a Sponsor Communication 
Form.
All dose reductions and interruptions (including any missed doses), and the reasons for the 
reductions/interruptions, per drug accountability and participant feedback reconciliation, are 
to be recorded in the eCRF. 
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Maintenance olaparib should be stopped at least 3 days prior to planned surgery and can be 
restarted when the wound has healed. It is not required to stop olaparib for any needle biopsy 
procedure.
Maintenance olaparib should be discontinued for a minimum of 3 days before a participant 
undergoes radiation treatment and should be restarted within 3 weeks (21 days) as long as 
any bone marrow toxicity has recovered. 
Because the AEs related to olaparib may include asthenia, fatigue and dizziness, participants 
should be advised to use caution while driving or using machinery if these symptoms occur.
6.6.2.5
Dose Reductions for Concurrent CYP3A4 Inhibitor Use
Strong or moderate CYP3A inhibitors should not be taken with olaparib. If there is no 
suitable alternative concomitant medication then the dose of olaparib should be reduced for 
the period of concomitant administration as described in Table 8. After the washout of the 
inhibitor is complete (Section 5.2), the olaparib dose cannot be re-escalated. The dose 
reduction of olaparib should be recorded in the eCRF with the reason documented as 
concomitant CYP3A4 inhibitor use.
Table 8
Dose Reduction of Olaparib with a Strong or Moderate CYP3A4 Inhibitor
Initial Dose
Strong CYP3A Inhibitor
Moderate CYP3A Inhibitor
300 mg BID
100 mg BID
150 mg BID
Abbreviation: BID = twice daily.
6.6.3
Immune-Related Events and Dose Modification (Withhold, Treat, 
Discontinue)
Dose Modification and Toxicity Management for Immune-related AEs Associated with 
Pembrolizumab
AEs associated with pembrolizumab exposure may represent an immune-related response. 
These irAEs may occur shortly after the first dose or several months after the last dose of 
pembrolizumab treatment and may affect more than one body system simultaneously. 
Therefore, early recognition and initiation of treatment is critical to reduce complications. 
Based on existing clinical study data, most irAEs were reversible and could be managed with 
interruptions of pembrolizumab, administration of corticosteroids and/or other supportive 
care. For suspected irAEs, ensure adequate evaluation to confirm etiology or exclude other 
causes. Additional procedures or tests such as bronchoscopy, endoscopy, skin biopsy may be 
included as part of the evaluation. Based on the severity of irAEs, withhold or permanently 
discontinue pembrolizumab and administer corticosteroids. 
Dose Modification and Toxicity Management Guidelines for irAEs associated with 
pembrolizumab monotherapy, coformulations, or IO combinations are provided in Table 9.
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Table 9
Dose Modification and Toxicity Management Guidelines for Immune-related Adverse Events Associated with 
Pembrolizumab Monotherapy, Coformulations or IO Combinations
General instructions:
1.
Severe and life-threatening irAEs should be treated with IV corticosteroids followed by oral steroids. Other immunosuppressive treatment should begin if 
the irAEs are not controlled by corticosteroids.
2.
Pembrolizumab monotherapy, coformulations or IO combinations must be permanently discontinued if the irAE does not resolve or the corticosteroid 
dose is not ≤10 mg/day within 12 weeks of the last treatment. 
3.
The corticosteroid taper should begin when the irAE is ≤ Grade 1 and continue at least 4 weeks.
4.
If pembrolizumab monotherapy, coformulations or IO combinations have been withheld, treatment may resume after the irAE decreased to ≤Grade 1 
after corticosteroid taper.
irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
Pneumonitis 
Grade 2
Withhold 
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
Monitor participants for signs and symptoms of 
pneumonitis
Evaluate participants with suspected pneumonitis 
with radiographic imaging and initiate 
corticosteroid treatment
Add prophylactic antibiotics for opportunistic 
infections
Recurrent Grade 2 
or Grade 3 or 4 
Permanently 
discontinue
Diarrhea / Colitis 
Grade 2 or 3
Withhold
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
Monitor participants for signs and symptoms of 
enterocolitis (ie, diarrhea, abdominal pain, blood or 
mucus in stool with or without fever) and of bowel 
perforation (ie, peritoneal signs and ileus)
Participants with ≥Grade 2 diarrhea suspecting 
colitis should consider GI consultation and 
performing endoscopy to rule out colitis
Participants with diarrhea/colitis should be advised 
to drink liberal quantities of clear fluids. If 
sufficient oral fluid intake is not feasible, fluid and 
electrolytes should be substituted via IV infusion.
Recurrent Grade 3 
or Grade 4
Permanently 
discontinue
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irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
AST / ALT 
Elevation or 
Increased 
Bilirubin
Grade 2
Withhold
Administer corticosteroids 
(initial dose of 0.5-1 mg/kg 
prednisone or equivalent) 
followed by taper
Monitor with liver function tests (consider weekly 
or more frequently until liver enzyme value 
returned to baseline or is stable)
Grade 3 or 4 
Permanently 
discontinue
Administer corticosteroids 
(initial dose of 1-2 mg/kg 
prednisone or equivalent) 
followed by taper
T1DM or 
Hyperglycemia
New onset T1DM 
or 
Grade 3 or 4 
hyperglycemia 
associated with 
evidence of β-cell 
failure
Withhold a
Initiate insulin replacement 
therapy for participants with 
T1DM
Administer anti-
hyperglycemic in participants 
with hyperglycemia
Monitor participants for hyperglycemia or other 
signs and symptoms of diabetes
Hypophysitis
Grade 2
Withhold
Administer corticosteroids 
and initiate hormonal 
replacements as clinically 
indicated
Monitor for signs and symptoms of hypophysitis 
(including hypopituitarism and adrenal 
insufficiency)
Grade 3 or 4
Withhold or 
permanently 
discontinue a
Hyperthyroidism 
Grade 2
Continue
Treat with non-selective 
beta-blockers (eg, 
propranolol) or thionamides 
as appropriate
Monitor for signs and symptoms of thyroid 
disorders
Grade 3 or 4
Withhold or 
Permanently 
discontinue a
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irAEs
Toxicity Grade 
(CTCAEv4.0)
Action With 
Pembrolizumab 
Monotherapy, 
Coformulations or 
IO Combinations
Corticosteroid and/or Other 
Therapies
Monitoring and Follow-up
Hypothyroidism
Grade 2-4
Continue
Initiate thyroid replacement 
hormones (eg, levothyroxine 
or liothyronine) per standard 
of care
Monitor for signs and symptoms of thyroid 
disorders
Nephritis and 
renal dysfunction
Grade 2
Withhold
Administer corticosteroids 
(prednisone 1-2 mg/kg or 
equivalent) followed by taper
Monitor changes of renal function
Grade 3 or 4
Permanently 
discontinue
Myocarditis
Grade 1 
Withhold
Based on severity of AE 
administer corticosteroids
Ensure adequate evaluation to confirm etiology 
and/or exclude other causes
Grade 2, 3 or 4
Permanently 
discontinue
All Other irAEs
Persistent Grade 2
Withhold
Based on severity of AE 
administer corticosteroids
Ensure adequate evaluation to confirm etiology or 
exclude other causes
Grade 3
Withhold or 
discontinue b
Recurrent Grade 3 
or Grade 4 
Permanently 
discontinue
AE(s)=adverse event(s); ALT= alanine aminotransferase; AST=aspartate aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events; DRESS=Drug Rash 
with Eosinophilia and Systemic Symptom; GI=gastrointestinal; IO=immuno-oncology; ir=immune-related; IV=intravenous; SJS=Stevens-Johnson Syndrome; 
T1DM=type 1 diabetes mellitus; TEN=Toxic Epidermal Necrolysis; ULN=upper limit of normal.
Note: Non-irAE will be managed as appropriate, following clinical practice recommendations.
a
The decision to withhold or permanently discontinue pembrolizumab monotherapy, coformulations or IO combinations is at the discretion of the investigator or treating 
physician. If control achieved or ≤ Grade 2, pembrolizumab monotherapy, coformulations or IO combinations may be resumed.
b
Events that require discontinuation include, but are not limited to: Guillain-Barre Syndrome, encephalitis, myelitis, DRESS, SJS, TEN and other clinically important irAEs
(eg, vasculitis and sclerosing cholangitis).
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Dose Modification and Toxicity Management of Infusion Reactions Related to 
Pembrolizumab
Pembrolizumab may cause severe or life-threatening infusion reactions including severe 
hypersensitivity or anaphylaxis. Signs and symptoms usually develop during or shortly after 
drug infusion and generally resolve completely within 24 hours of completion of infusion. 
Dose modification and toxicity management guidelines on pembrolizumab associated 
infusion reaction are provided in Table 10.
Table 10
Pembrolizumab Infusion Reaction Dose Modification and Treatment Guidelines
NCI CTCAE Grade
Treatment
Premedication at 
Subsequent Dosing
Grade 1
Mild reaction; infusion 
interruption not 
indicated; intervention 
not indicated
Increase monitoring of vital signs as medically 
indicated until the participant is deemed medically 
stable in the opinion of the investigator.
None
Grade 2
Requires therapy or 
infusion interruption,
but responds promptly 
to symptomatic 
treatment (eg, 
antihistamines, 
NSAIDs, narcotics, IV 
fluids); prophylactic 
medications indicated 
for ≤24 h
Stop Infusion.
Additional appropriate medical therapy may 
include, but is not limited to:
IV fluids
Antihistamines
NSAIDs
Acetaminophen
Narcotics
Increase monitoring of vital signs as medically 
indicated until the participant is deemed medically 
stable in the opinion of the investigator.
If symptoms resolve within 1 hour of stopping 
drug infusion, the infusion may be restarted at 
50% of the original infusion rate (eg, from 
100 mL/hr to 50 mL/hr). Otherwise, dosing will be 
held until symptoms resolve and the participant 
should be premedicated for the next scheduled 
dose.
Participants who develop Grade 2 toxicity 
despite adequate premedication should be 
permanently discontinued from further study 
drug treatment.
Participant may be 
premedicated 1.5 h (± 30 
minutes) prior to infusion of 
pembrolizumab with:
Diphenhydramine 50 mg po
(or equivalent dose of 
antihistamine).
Acetaminophen 500-
1000 mg po (or equivalent 
dose of analgesic).
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NCI CTCAE Grade
Treatment
Premedication at 
Subsequent Dosing
Grades 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.
Additional appropriate medical therapy may 
include, but is not limited to:
Epinephrine**
IV fluids
Antihistamines
NSAIDs
Acetaminophen
Narcotics
Oxygen
Pressors
Corticosteroids
Increase monitoring of vital signs as medically 
indicated until the participant is deemed medically 
stable in the opinion of the investigator.
Hospitalization may be indicated.
**In cases of anaphylaxis, epinephrine should be 
used immediately.
Participant is permanently discontinued from 
further study drug treatment.
No subsequent dosing
Appropriate resuscitation equipment should be available at the bedside and a physician readily available during the 
period of drug administration.
For further information, please refer to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) at 
http://ctep.cancer.gov
Other Allowed Dose Interruption for Pembrolizumab
Pembrolizumab may be interrupted for situations other than treatment-related AEs such as 
medical or surgical events and/or unforeseen circumstances not related to study intervention. 
However, study intervention is to be restarted within 3 weeks of the originally scheduled 
dose and within 42 days of the previously administered dose, unless otherwise discussed with 
the Sponsor. The reason for interruption is to be documented in the participant’s study 
record.
6.6.4
Carboplatin and Paclitaxel or Nab-paclitaxel Dose Modification
If a participant experiences a ≥10% weight change during Cycles 1 to 4, the doses of 
carboplatin and paclitaxel/nab-paclitaxel should be recalculated.
Dose modifications due to AEs will depend on the investigator’s assessment of causality. If 
appropriate, the investigator may attribute each toxicity event to carboplatin, paclitaxel/nab-
paclitaxel, and pembrolizumab alone or to the combination and use a stepwise dose reduction 
according to approved product labels for dose modifications regarding this regimen. Dose 
modifications must be based on the maximum toxicity experienced during a cycle. Toxicity 
must resolve to Grade ≤1 or baseline prior to resuming the subsequent cycle, with the 
exception of alopecia, Grade 2 fatigue, and Grade ≤ 2 endocrine-related AEs requiring 
treatment or hormone replacement; for anemia and creatinine clearance, the guidelines 
provided in Table 3 may be followed.
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If a dose reduction for toxicity occurs with any agent, the dose may not be re-escalated. 
Participants can have a maximum of 2 dose modifications (if applicable) to each of the 
components of study therapy throughout the course of the study for toxicities. If a participant
experiences several toxicities and there are conflicting recommendations, the most 
conservative dose adjustment recommended should be followed (ie, dose reduction 
appropriate to the most severe toxicity). Participants who require a third dose modification to 
any particular component will have that agent discontinued. In the absence of the agent 
thought to be causing toxicity, treatment can continue with pembrolizumab and the 
remaining chemotherapeutic drug. Once the dose has been decreased, it should remain 
reduced for all subsequent administrations or be further reduced, if necessary. There will be 
no dose escalations in this study.
Reduction of one chemotherapy agent and not the other agent is appropriate if, in the opinion 
of the investigator, the toxicity is clearly related to one of the treatments. If, in the opinion of 
the investigator, the toxicity is related to the combination of both 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 agents should be reduced (if applicable), 
interrupted, or discontinued according to the recommended dose modifications. If all 3 agents 
are discontinued due to a toxicity without completing 4 cycles of the Induction Phase, the 
participant cannot proceed to the Maintenance Phase. 
Pembrolizumab dose reductions are not permitted. Pembrolizumab treatment may be 
delayed/interrupted for a maximum of 12 weeks. However, for participants to proceed to the 
Maintenance Phase, the toxicity must resolve to Grade ≤1 or baseline prior to resuming the 
subsequent cycle, with the exception of alopecia, Grade 2 fatigue, and Grade ≤ 2 endocrine-
related AEs requiring treatment or hormone replacement; for anemia and creatinine 
clearance, the guidelines provided below may be followed.
During the Induction Phase, study drug-related toxicities must be resolved to baseline or 
Grade ≤1 (with the exception of alopecia, Grade 2 fatigue, and Grade ≤ 2 endocrine-related 
AEs requiring treatment or hormone replacement; for anemia and creatinine clearance, the 
guidelines provided below may be followed) prior to administering the next dose. 
Participants must not receive the next cycle of chemotherapy if any of the following apply:
•
Absolute neutrophil count (ANC) <1,500/mm3
•
Platelet count <100,000/mm3
•
Hemoglobin level <9 g/dL
•
Total bilirubin level >1.5 × ULN
•
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 
≥2.5 × ULN, or ≥5 × ULN if liver metastases are present
•
CrCl <51 mL/min (CrCl will be based the Cockcroft-Gault formula 
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During Cycles 1 through 4 of carboplatin plus paclitaxel/nab-paclitaxel:
•
If paclitaxel/nab-paclitaxel dosing is delayed or interrupted on Day 1, the platinum agent 
and pembrolizumab should also be delayed/interrupted. If carboplatin plus paclitaxel/nab-
paclitaxel is delayed or interrupted during Cycles 1 through 4, participants should be seen 
weekly until toxicity resolves.
•
If carboplatin dosing is delayed or interrupted on Day 1, paclitaxel/nab-paclitaxel and 
pembrolizumab should also be delayed/interrupted. If carboplatin plus paclitaxel/nab-
paclitaxel is delayed or interrupted during Cycles 1 through 4, participants should be seen 
weekly until toxicity resolves.
•
If pembrolizumab dosing is delayed or interrupted, carboplatin plus paclitaxel/nab-
paclitaxel therapy can continue as scheduled. Pembrolizumab administration should be 
attempted at the next cycle of therapy.
•
Each chemotherapy cycle may not be delayed by more than 3 weeks (>21 consecutive 
days) despite supportive treatment. If only one of the agents is thought to be causing the 
specified toxicity leading to a 21-day delay of administration of the next cycle, that 
chemotherapeutic agent can be withheld and treatment can continue with pembrolizumab 
and the remaining chemotherapy drug. 
The CTCAE 4.0 must be used to grade the severity of AEs. All dose modifications should be 
based on the AE requiring the greatest dose modification. Dose modifications are detailed in
Table 5 through Table 11. These serve as a guide and do not replace investigator judgment 
and applicable local label recommendations, if more stringent.
Table 11
Dose Modification for Chemotherapeutic Agents
Drug
Dose Level-0
Dose Level-1
Dose Level-2
Dose Level-3
Carboplatin
AUC 6 mg/mL/min
Maximum dose
900 mg
AUC 
4.5 mg/mL/min
Maximum dose
675 mg
AUC 3 mg/mL/min
Maximum dose
450 mg
Discontinue
Paclitaxel
200 mg/m2
150 mg/m2
100 mg/m2
Discontinue
Nab-Paclitaxel
100 mg/m2
75 mg/m2
50 mg/m2
Discontinue
Abbreviation: AUC=area under the concentration-time curve; BID=twice daily
Note: For olaparib/olaparib placebo, follow dose modifications as outlined in Section 6.6.2 (and all of its subsections).
For pembrolizumab, follow dose modifications as outlined in Section 6.6.3.
Recommended dose modifications for key chemotherapy toxicities are outlined in Table 12
and Table 13. These serve as a guide and do not replace investigator judgment and applicable 
local label recommendations, if more stringent. These data are based on Day 1 cell counts.
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Table 12
Recommended Chemotherapy Dose Modifications for Hematological Toxicity
Platelets
ANC
Carboplatin
Paclitaxel
Nab-
Paclitaxel
Dose Level (DL) from Table 11
≥50,000/mcL
AND
≥ 500/mcL
DL 0
DL 0
DL-0 a
≥50,000/mcL
AND
< 500/mcL
without fever
DL -1
DL -1
DL-1
<50,000/mcL 
without significant 
bleeding nor 
requiring blood 
transfusions AND
ANY
DL -1
DL -1
DL-1
<50,000/mcL with 
Grade ≥2 
hemorrhage or 
requiring blood 
transfusions AND
ANY
DL -2
DL -2
DL-2
ANY AND
< 1,000/mcL
+ fever 
≥38.5°C 
(101°F)
DL -1
DL -1
DL-1
Abbreviations:  ANC = absolute neutrophil counts; DL = dose level; mcL = microliter(s).
Should the hematologic toxicity recur; the dose of the agent could be reduced further. However, not more than 2 dose 
reductions per chemotherapy agent are permitted.
a.
Do not administer nab-paclitaxel on Day 1 of a cycle until ANC is at least 1500 cells/mm3 and platelet count is at 
least 100,000 cells/mm3. In participants who develop severe neutropenia or thrombocytopenia withhold treatment until 
counts recover to an absolute neutrophil count of at least 1500 cells/mm3 and platelet count of at least 100,000 cells/mm3
on Day 1 or to an absolute neutrophil count of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on 
Days 8 or 15 of the cycle.
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Table 13
Recommended Dose Modifications for Chemotherapy Nonhematological Toxicity
Event
CTCAE
Grade
Carboplatin
Paclitaxel
Nab-
Paclitaxel
Dose Level (DL) from Table 11
Nausea or Vomiting
Grade 3 or 
4
DL-1
DL-1
DL-0
Diarrhea
Grade 3 or 
4
DL -1
DL -1
DL 0
Mucositis
Grade 3 or 
4
DL -1
DL-1
DL 0
Neurotoxicity
Grade 2
DL 0
DL -2
DL 0
Grade 3 or 
4
DL -1
Discontinue
DL -1
Total Bilirubin Elevation
Grade 2
DL-0
DL-2
DL-0
Grade 3 or 
4
DL-0
Discontinue
DL-0
Transaminase Elevation
Grade 3
DL -1
Discontinue
DL -1
Grade 4
Discontinue
Discontinue
Discontinue
Other Nonhematological Toxicity (except 
fatigue and transient arthralgia and myalgia)
Grade 3 or 
4
DL -1
DL -1
DL -1
Abbreviations:  CTCAE = Common Terminology Criteria for Adverse Events; DL = dose level.
6.7
Intervention After the End of the Study
There is no study-specified intervention following the end of the study.
6.8
Clinical Supplies Disclosure
The emergency unblinding call center will use the intervention randomization schedule for 
the study to unblind participants and to unmask study intervention identity for the 
Maintenance Phase of this study. The emergency unblinding call center should only be used 
in cases of emergency (see Section 8.1.10). Participants whose treatment assignment has 
been unblinded by the investigator/delegate and/or non-study treating physician must be 
discontinued from study drug, but should continue to be monitored in the trial. The Sponsor 
will not provide random code/disclosure envelopes or lists with the clinical supplies.
6.9
Standard Policies
At the close of the study after unblinding, a letter is to be sent by the investigator to those 
participants who received placebos in the image of the competitor’s product to provide the 
following advice: “You have participated in a study conducted by the Sponsor. This letter is 
to advise you that you were among those who received a look-alike tablet created by the 
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Sponsor to resemble the drug Olaparib as much as possible. You did not receive the active 
drug Olaparib as manufactured by Astra Zeneca.”
6.9.1
Study Site Retention Samples
Not applicable.
7
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
WITHDRAWAL
7.1
Discontinuation of Study Intervention
Discontinuation of study intervention does not represent withdrawal from the study.
As certain data on clinical events beyond study intervention discontinuation may be 
important to the study, they must be collected through the participant’s last scheduled follow-
up, even if the participant has discontinued study intervention. Therefore, all participants 
who discontinue study intervention prior to completion of the protocol-specified treatment 
period will still continue to participate in the study as specified in Section 1.3 and 
Section 8.12.4.
Participants may discontinue study intervention at any time for any reason or be discontinued 
from the study intervention at the discretion of the investigator should any untoward effect 
occur. In addition, a participant may be discontinued from study intervention by the 
investigator or the Sponsor if study intervention is inappropriate, the study plan is violated, or 
for administrative and/or other safety reasons. Specific details regarding procedures to be 
performed at study intervention discontinuation are provided in Section 8.1.8.2 and 
Section 8.12.4.
A participant must be discontinued from study intervention but continue to be monitored in 
the study for any of the following reasons:
•
The participant or participant’s legally acceptable representative requests to discontinue 
study intervention.
•
Radiographic disease progression outlined in Section 8.2 (exception if the Sponsor 
approves treatment continuation following confirmed PD per iRECIST).
Note: As of Amendment 07, central tumor response assessments will no longer be 
performed. Participants on study treatment will be assessed locally by the investigator for 
disease progression, based on the site’s standard of care imaging schedule. Participants 
with PD per local investigator assessment should be discontinued (except if the Sponsor 
approves treatment continuation following PD). 
•
Any progression or recurrence of any malignancy, or any occurrence of another 
malignancy that requires treatment.
•
Unacceptable AEs or toxicities (Section 6.6).
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•
Any study intervention-related toxicity specified as a reason for permanent 
discontinuation as defined in the guidelines for dose modification due to AEs in 
Section 6.6 (eg, recurrent Grade 2 pneumonitis, recurrent Grade 3 colitis, recurrent Grade 
3 diarrhea).
•
If a participant with liver metastasis has Grade 2 AST or ALT at the start of study 
treatment, and the AST or ALT value increases by ≥50% relative to baseline and lasts for 
≥1 week, then the participant should permanently discontinue study intervention.
•
Bone marrow findings consistent with MDS or AML.
•
Interruption of carboplatin/taxane (paclitaxel/nab-paclitaxel) for more than 6 weeks 
without Sponsor consultation.
•
Interruption of pembrolizumab administration for more than 12 consecutive weeks for an 
AE/toxicity or for more than 3 weeks for administrative reasons without Sponsor 
consultation.
•
Interruption of administration of olaparib or olaparib placebo for more than 21
consecutive days without Sponsor consultation.
•
Intercurrent illness other than another malignancy as noted above that prevents further 
administration of treatment.
•
Participant has a medical condition or personal circumstance that, in the opinion of the 
investigator and/or Sponsor, placed the participant at unnecessary risk from continued 
administration of study intervention.
•
The participant has a confirmed positive serum pregnancy test.
•
Prohibited medication or vaccination required, and agreement between Sponsor, 
Investigator, and participant to discontinue (Section 6.5.1).
Any prolonged interruption of study intervention beyond the permitted periods, for irAE 
management or other allowed dose interruptions, as noted in Section 6.6.3 require Sponsor 
consultation prior to restarting treatment. If treatment will not be restarted, the participant 
will continue to be monitored in the study and the reason for discontinuation of study 
intervention will be recorded in the medical record.
For participants who are discontinued from study intervention, but continue to be monitored 
in the study, all visits and procedures, as outlined in the SoA, should be completed.
Discontinuation from study intervention is “permanent.” Once a participant is discontinued, 
he/she shall not be allowed to restart study intervention.
Participants in this study may discontinue in the Induction Phase due to progression of 
disease or not meeting eligibility criteria to proceed to the Maintenance Phase (as listed in 
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Section 5.1). Upon completion of the End-of-Treatment/Safety Follow-up Visit, these 
participants are to be discontinued from the study and are no longer followed.
7.2
Participant Withdrawal From the Study
If the participant or participant’s legally acceptable representative withdraws consent, the 
participant must be withdrawn from the study.
If a participant withdraws consent, they will no longer receive study intervention or be 
followed at scheduled protocol visits.
Specific details regarding procedures to be performed at the time of withdrawal from the 
study, as well as specific details regarding withdrawal from future biomedical research, are 
outlined in Section 8.1.8.2 and 8.1.8.3. If a participant fails to return for scheduled visits 
and/or if the study site is unable to contact the participant after multiple attempts (ie, is lost to 
follow-up), the procedures to be performed are outlined in Section 7.3.
Any AEs that are present at the time of withdrawal should be followed in accordance with 
the safety requirements outlined in Section 8.4. 
7.3
Lost to Follow-up
If a participant fails to return to the clinic for a required study visit and/or if the site is unable 
to contact the participant, the following procedures are to be performed:
•
The site must attempt to contact the participant and reschedule the missed visit. If the 
participant is contacted, the participant should be counseled on the importance of 
maintaining the protocol-specified visit schedule.
•
The investigator or designee must make every effort to regain contact with the participant 
at each missed visit (eg, telephone calls and/or a certified letter to the participant’s last 
known mailing address or locally equivalent methods). These contact attempts should be 
documented in the participant’s medical record.
Note: A participant is not considered lost to follow-up until the last scheduled visit for the 
individual participant. The missing data for the participant will be managed via the 
prespecified statistical data handling and analysis guidelines.
8
STUDY ASSESSMENTS AND PROCEDURES
•
Study procedures and their timing are summarized in the SoA.
•
Adherence to the study design requirements, including those specified in the SoA, is 
essential and required for study conduct.
•
The investigator is responsible for ensuring that procedures are conducted by 
appropriately qualified or trained staff. Delegation of study site personnel responsibilities 
will be documented in the Investigator Trial File Binder (or equivalent).
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•
All study-related medical decisions must be made by an investigator who is a qualified 
physician.
•
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
•
Procedures conducted as part of the participant’s routine clinical management (eg, blood 
count) and obtained before providing documented informed consent may be utilized for 
screening or baseline purposes provided the procedure met the protocol-specified criteria 
and were performed within the time frame defined in the SoA.
•
Additional evaluations/testing may be deemed necessary by the investigator and or the 
Sponsor for reasons related to participant safety. In some cases, such evaluation/testing 
may be potentially sensitive in nature (eg, HIV, Hepatitis C), and thus local regulations 
may require that additional informed consent be obtained from the participant. In these 
cases, such evaluations/testing will be performed in accordance with those regulations.
Repeat or unscheduled samples may be taken for safety reasons or for technical issues with 
the samples.
8.1
Administrative and General Procedures
8.1.1
Informed Consent
The investigator or medically qualified designee (consistent with local requirements) must 
obtain documented informed consent from each potential participant (or their legally 
acceptable representative) prior to participating in this clinical study or future biomedical 
research. If there are changes to the participant’s status during the study (eg, health or age of 
majority requirements), the investigator or medically qualified designee must ensure the 
appropriate documented informed consent is in place.
8.1.1.1
General Informed Consent
Informed consent given by the participant or their legally acceptable representative must be 
documented on a consent form. The form must include the study protocol number, study 
protocol title, dated signature, and /agreement of the participant (or his/her legally acceptable 
representative) and of the person conducting the consent discussion.
A copy of the signed and dated informed consent form should be given to the participant (or 
their legally acceptable representative) before participation in the study.
The initial ICF, any subsequent revised ICF, and any written information provided to the 
participant must receive the Institutional Review Board/Independent Ethics Committee’s 
(IRB/IEC’s) approval/favorable opinion in advance of use. The participant or his/her legally 
acceptable representative should be informed in a timely manner if new information becomes 
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available that may be relevant to the participant’s willingness to continue participation in the 
study. The communication of this information will be provided and documented via a revised 
consent form or addendum to the original consent form that captures the participant’s or the 
participant’s legally acceptable representative’s dated signature.
The participant (or their legally acceptable representative) will be asked to provide 
documented informed consent at the point of initial radiographic disease progression.
Specifics about a study and the study population will be added to the consent form.
Informed consent will adhere to IRB/IEC requirements, applicable laws and regulations, and 
Sponsor requirements.
8.1.1.2
Consent and Collection of Specimens for Future Biomedical Research
The investigator or medically qualified designee will explain the future biomedical research 
consent to the participant or the participant’s legally acceptable representative, answer all of 
his/her questions, and obtain documented informed consent before performing any procedure 
related to future biomedical research. A copy of the informed consent will be given to the 
participant before performing any procedure related to future biomedical research.
8.1.2
Inclusion/Exclusion Criteria
All inclusion and exclusion criteria will be reviewed by the investigator who is a qualified 
physician to ensure that the participant qualifies for the study.
8.1.3
Participant Identification Card
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 used 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 documented informed consent. At the time of intervention
allocation/randomization, site personnel will add the treatment/randomization number to the 
participant identification card.
The participant identification card also contains contact information for the emergency 
unblinding call center so that a health care provider can obtain information about study 
intervention in emergency situations where the investigator is not available.
8.1.4
Medical History
A medical history will be obtained by the investigator or qualified designee. The medical 
history will collect all active conditions and any condition diagnosed within the prior 
10 years that the investigator considers to be clinically important. Include history of blood 
transfusion within previous 120 days from start of study intervention and the reasons, eg, 
bleeding or myelosuppression. Details regarding the disease for which the participant has 
enrolled in this study will be recorded separately and not listed as medical history.
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If a medical condition is diagnosed at the time of Screening due to the physical examination, 
laboratory tests, radiologic assessment, other assessment, and/or a combination of these 
evaluations, the medical condition is to be recorded as a baseline condition along with the 
participant’s other medical history unless due to any protocol-specified intervention (eg, 
procedure or washout).
8.1.4.1
Non-small Cell Lung Cancer History
The investigator or qualified designee will obtain prior and current details regarding the 
participant’s NSCLC.
8.1.5
Prior and Concomitant Medications Review
8.1.5.1
Prior 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 first dose of study intervention. 
8.1.5.2
Concomitant Medications
The investigator or qualified designee will record medication (including blood transfusions), 
if any, taken by the participant during the study.
8.1.5.3
Subsequent Antineoplastic Therapy
Details of subsequent therapies for cancer and/or details of radiation therapy and surgery for 
the treatment of the cancer, after discontinuation of study intervention, will be collected. 
Reasons for starting subsequent antineoplastic therapies including access to other PARP 
inhibitors, PD-1/PD-L1 inhibitors, or investigational drugs will be collected.
8.1.6
Assignment of Screening Number
All consented participants will be given a unique screening number that will be used to 
identify the participant for all procedures that occur prior to intervention allocation. Each 
participant will be assigned only 1 screening number. Screening numbers must not be re-used 
for different participants.
Any participant who is screened multiple time will retain the original screening number 
assigned at the initial screening visit.
Specific details on the screening visit requirements (screening/rescreening) are provided in 
Section 8.12.1.
8.1.7
Assignment of Treatment/Randomization Number
All participants eligible for study intervention will continue to be treated using the initial 
assigned screening number. All participants eligible for the Maintenance Phase who are 
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randomized will receive an allocation/randomization number. The allocation/randomization 
number identifies the participant for all procedures occurring after randomization to the 
Maintenance Phase. Once a treatment/randomization number is assigned to a participant, it 
can never be re-assigned to another participant.
A single participant cannot be assigned more than 1 allocation/randomization number. 
For those participants that are treated as per the Induction Phase and are not randomized to 
the Maintenance Phase, a separately devised allocation number will be assigned.
8.1.8
Study Intervention Administration
Administration of pembrolizumab, carboplatin, and paclitaxel or nab-paclitaxel during the 
Induction Phase will be monitored by the investigator and/or study staff. 
During the Maintenance Phase, administration of pembrolizumab will be monitored by the 
investigator and/or study staff on Day 1 of each cycle; olaparib or olaparib placebo will be 
monitored by the investigator and/or study staff on Day 1 of the first cycle according to the 
specifications within the pharmacy manual. Participants will then self-administer olaparib or 
olaparib placebo orally for the remainder of the 21-day treatment cycle. 
Study intervention should begin within 3 days of treatment allocation for the Induction Phase 
and within 3 days of treatment randomization in the Maintenance Phase.
Note: As of Amendment 07, participants who are confirmed to be actively taking placebo 
should discontinue taking the placebo intervention and continue in the study. Participants 
taking Olaparib should continue receiving it per investigator’s discretion after discussion. 
Participants who are potential candidates for Second Course treatment will continue in 
Efficacy Follow-up. Participants currently undergoing or who will undergo Second Course 
with pembrolizumab monotherapy can continue or start treatment per investigator’s 
discretion under this protocol or under an extension study.
8.1.8.1
Timing of Dose Administration
On Day 1 of each cycle, study intervention should be administered after all procedures and 
assessments have been completed. Study intervention can be administered ±3 days of the 
targeted Day 1 for each cycle. 
Cycles 1 – 4 (Induction Phase):
Participants will receive pembrolizumab 200 mg (Day 1) together with carboplatin AUC 
6 mg/mL/min and investigator’s choice of paclitaxel 200 mg/m2 or nab-paclitaxel 100 mg/m2
for 4 cycles.
Cycle 1 onwards (Maintenance Phase):
Participants will continue pembrolizumab 200 mg and begin maintenance therapy with either 
olaparib 300 mg or olaparib placebo BID.
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Note: As of Amendment 07, participants who are confirmed to be actively taking placebo 
should discontinue taking the placebo intervention and continue in the study. The protocol 
content has been retained for reference.
8.1.8.1.1
Pembrolizumab
Pembrolizumab will be administered as a 30-minute IV infusion Q3W. Pembrolizumab will 
be administered prior to chemotherapy. Sites should make every effort to target infusion 
timing to be as close to 30 minutes as possible. However, given the variability of infusion 
pumps from site to site, a window of – 5 minutes and + 10 minutes is permitted (ie, infusion 
time is 30 minutes:  -5 minutes/+ 10 minutes).
8.1.8.1.2
Paclitaxel or Nab-paclitaxel
Paclitaxel or nab-paclitaxel will be administered approximately 30 minutes after 
pembrolizumab and should be completely administered prior to initiating the carboplatin 
dose.
•
Paclitaxel (200 mg/m2 Q3W) will be administered as an IV infusion over 3 hours for 4
cycles as per local practice and labels. All participants should be premedicated with oral 
or IV steroid and antihistamines according to the approved product label and/or standard 
practice. Additional premedications should be administered as per standard practice.
•
Nab-paclitaxel will be administered at 100 mg/m2 as an IV infusion over 30 minutes for 
4 cycles as per local practice and labels. Participants will be dosed on Day 1, 8 and 15 of 
each Q3W cycle.
Participants are allowed to switch from paclitaxel to nab-paclitaxel if the participant 
experiences an infusion reaction to paclitaxel and the investigator considers switching to be 
in the best interest of the participant. Switching from paclitaxel to nab-paclitaxel requires
consultation between the investigator and the Sponsor and written documentation of the 
collaborative decision.
8.1.8.1.2.1
Carboplatin
Carboplatin (AUC 6 [mg/mL/min]) will be administered as an IV infusion over 
approximately 60 minutes Q3W on Day 1 for each of the 4 cycles (Induction Phase) and after 
paclitaxel or nab-paclitaxel as per local practice and labels. The carboplatin dose should be 
calculated using the Calvert formula (see below) and should not exceed 900 mg.
Calvert Formula:
•
Total dose (mg) = (target AUC) (CrCl + 25)
•
The estimated CrCl in the Calvert formula should not exceed 125 mL/min
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•
Maximum carboplatin dose (mg) = target AUC 6 (125 + 25)
= 6 150
= 900 mg
Creatinine clearance must be calculated using either the Cockcroft-Gault formula or another 
acceptable standard formula for estimating CrCl in mL/min based on serum creatinine:
•
Men: [(140 - age (y)) weight (kg)]/[72 serum creatinine (mg/dL)]
•
Women: [(140 - age (y)) weight (kg)] 0.85/[72 serum creatinine (mg/dL)]
Note: Dose may be rounded to the nearest 50 mg at the discretion of the investigator, and
according to institutional standards.
Unless there is a change in weight ≥10%, the same dose of carboplatin can be used 
throughout the 4 cycles of the Induction Phase (provided there are no additional toxicities).
Additional premedications should be administered as per standard practice.
8.1.8.1.3
Olaparib or Olaparib Placebo
Participants must have at least one evaluable imaging timepoint and no overall response of 
PD prior to starting either olaparib or olaparib placebo in the Maintenance Phase. To initiate 
or continue with olaparib or olaparib placebo, CrCl must be ≥51 mL/min. During the 
Maintenance Phase, ingestion of olaparib or olaparib placebo will be monitored by the 
investigator and/or study staff on Day 1 of first cycle and participants will then self-
administer olaparib orally for the remainder of the 21-day treatment cycle. Participants will 
be instructed to self-administer olaparib or olaparib placebo at approximately the same time 
of day. If vomiting occurs within 2 hours after the olaparib or olaparib placebo tablets are 
swallowed, the dose should only be replaced if all of the intact tablets can be seen and 
counted. 
If a participant misses a scheduled dose for any reason (eg, as a result of forgetting to take 
the tablets or vomiting), the participant will be allowed to take the scheduled dose up to a 
maximum of 2 hours after that scheduled dose time. If greater than 2 hours after the 
scheduled dose time, the missed dose is not to be taken and the participant should take their 
allotted dose at the next scheduled time.
Refer to the Olaparib Pharmacy Manual for further details on dose administration.
Note: As of Amendment 07, participants who are confirmed to be actively taking placebo 
should discontinue taking the placebo intervention and continue in the study. Participants 
taking Olaparib should continue receiving it per Investigator’s discretion after discussion. 
Participants taking or will take pembrolizumab monotherapy (Second Course), should/will 
continue receiving it if they qualify per protocol. The protocol content has been retained for 
reference.
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8.1.8.1.4
Colony-stimulating Factors
During the Induction Phase, the use of CSFs is highly recommended as primary prophylaxis 
to reduce the risk of febrile neutropenia in this participant population, especially as many 
participants have multiple comorbidities and advanced disease. G-CSF should not be used 
within 14 days prior to randomization.
During the Maintenance Phase, primary prophylaxis with G-CSF is not recommended; 
however, if a participant develops febrile neutropenia, study intervention should be 
interrupted and appropriate management including G-CSF should be given according to local 
hospital guidelines. Please note that G-CSF should not be used within at least 24 hours (7 
days for pegylated G-CSF) of the last dose of study intervention unless absolutely necessary.
The American Society of Clinical Oncology guidelines for use of CSFs should be followed 
for this study [Smith, T. J., et al 2015].
8.1.8.1.5
Antiemetic Therapy
Antiemetic therapy should follow the Multinational Association of Supportive Care in 
Cancer (MASCC) guidelines [Roila, F., et al 2016]. In each cycle of treatment during the 
Induction Phase, antiemetic therapy should include a 5-HT3 receptor antagonist, 
dexamethasone (or equivalent), and/or aprepitant [Roila, F., et al 2016]. Some antiemetics 
are inducers/inhibitors of CYP3A4 (e.g., aprepitant); consider the required washout period 
before starting olaparib/olaparib placebo.
8.1.8.2
Discontinuation and Withdrawal
Section 7.2 provides a complete description of withdrawal of consent from the study.
Participants who withdraw consent from the study should be encouraged to complete all 
applicable activities scheduled for the final study visit at the time of withdrawal.
8.1.8.3
Withdrawal From Future Biomedical Research
Participants may withdraw their consent for future biomedical research. Participants may 
withdraw consent at any time by contacting the principal investigator for the main study. If 
medical records for the main study are still available, the investigator will contact the 
Sponsor using the designated mailbox (clinical.specimen.management@MSD.com). 
Subsequently, the participant's consent for future biomedical research will be withdrawn. A 
letter will be sent from the Sponsor to the investigator confirming the withdrawal. It is the 
responsibility of the investigator to inform the participant of completion of withdrawal. Any 
analyses in progress at the time of request for withdrawal or already performed prior to the 
request being received by the Sponsor will continue to be used as part of the overall research 
study data and results. No new analyses would be generated after the request is received.
In the event that the medical records for the main study are no longer available (eg, if the 
investigator is no longer required by regulatory authorities to retain the main study records) 
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or the specimens have been completely anonymized, there will no longer be a link between 
the participant’s personal information and their specimens. In this situation, the request for 
specimen withdrawal cannot be processed. 
8.1.9
Participant Blinding/Unblinding
The study intervention during the Induction Phase is open-label.
During the Maintenance Phase, when the investigator or delegate needs to identify the drug 
used by a participant and the dosage administered in case of emergency, eg, the occurrence 
of serious AEs, he/she will contact the emergency unblinding call center by telephone and 
make a request for emergency unblinding. As requested by the investigator or delegate the 
emergency unblinding call center will provide the information to him/her promptly and 
report unblinding to the Sponsor. Prior to contacting the emergency unblinding call center to 
request unblinding of a patient’s treatment assignment, the investigator or delegate must 
enter the toxicity grade of the AEs observed, the relation to study drug, the reason thereof, 
etc., in the medical chart, etc.
Participants whose treatment assignment has been unblinded by the investigator/delegate 
and/or non-study treating physician must be discontinued from study drug, but should 
continue to be monitored in the trial.
Treatment identification information is to be unmasked ONLY if necessary for the welfare of 
the participant. Every effort should be made not to unblind the participant unless necessary. 
In the event that unblinding has occurred, the circumstances around the unblinding (eg, date, 
reason, and person performing the unblinding) must be documented promptly, and the 
Sponsor Clinical Director notified as soon as possible. Once an emergency unblinding or a 
non-emergency unblinding has taken place, the principal investigator, site personnel, and 
Sponsor personnel may be unblinded so that the appropriate follow-up medical care can be 
provided to the patient.
Note: Based on the IA3 data, the study was unblinded on 15-DEC-2023. The unblinding 
processes are no longer relevant. Original protocol text has been retained for reference.
8.1.10
Calibration of Equipment
The investigator or qualified designee has the responsibility to ensure that any device or 
instrument used for a clinical evaluation/test during a clinical study that provides information 
about inclusion/exclusion criteria and/or safety or efficacy parameters shall be suitably 
calibrated and/or maintained to ensure that the data obtained is reliable and/or reproducible. 
Documentation of equipment calibration must be retained as source documentation at the 
study site.
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8.1.11
Tumor Tissue for Biomarker Status
During the screening period, a tumor sample for each participant is required and is to be:
•
A newly obtained core, incisional, or excisional biopsy of a tumor lesion, which was not 
previously irradiated
Or
•
An archival tumor tissue sample if a new biopsy is unavailable (depending on protocol 
requirements)
FFPE tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived 
tissue.
Details pertaining to tumor tissue submission can be found in the Laboratory Manual.
The central laboratory will use the tissue sample to ascertain PD-L1 status using the PD-L1 
IHC 22C3 pharmDx (Investigational Use Only) diagnostic kit. The diagnostic test is identical 
to the US FDA-approved PD-L1 IHC 22C3 pharmDx diagnostic kit except it is labeled IUO. 
The PD-L1 IHC 22C3 pharmDx assay kit is currently approved to assess PD-L1 status in 
participants with NSCLC for treatment with pembrolizumab.
The PD-L1 result will be masked to the site.
8.2
Efficacy/Immunogenicity Assessments
Immunogenicity assessments will not be performed in this study.
8.2.1
Tumor Imaging and Assessment of Disease
Note: As of Amendment 7, participants who are still on study treatment will no longer 
require tumor response assessments by BICR to be performed. Scans will not be submitted to 
the iCRO. Participants who are still on study treatment and who have not experienced 
radiographic disease progression will be assessed locally by the investigator for disease 
progression, based on the site’s standard of care imaging schedule. Original protocol text in 
this section has been retained for reference.
The process for image collection and transmission to the central imaging vendor can be 
found in the Site Imaging Manual (SIM). Tumor imaging is strongly preferred as follows
•
CT with IV and oral contrast (preferred) of the chest, abdomen and pelvis for all 
participants, or non-contrast CT of the chest and MRI of the abdomen and pelvis with IV 
gadolinium for participants in whom iodinated contrast is contraindicated
•
MRI (strongly preferred) or CT with contrast (when MRI is medically contraindicated) of 
the brain
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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. Note: for the purposes of assessing 
tumor imaging, the term “investigator” refers to the local investigator at the site and/or the 
radiological reviewer at the site or at an offsite facility.
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, as well as imaging obtained for 
other reasons, but captures radiologic progression based on investigator assessment, should 
also be submitted to the central imaging vendor. 
When the investigator identifies radiographic progression per RECIST 1.1, the central 
imaging vendor will perform expedited verification of radiologic disease progression and 
communicate the results to the study site and Sponsor. Progression of disease should be 
verified centrally before intervention is discontinued if the participant is clinically stable. If 
the participant is clinically stable, treatment should continue until PD has been centrally 
verified. Regardless of whether PD is verified, 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 time points. Images should continue 
to be submitted to the central imaging vendor until VOP is confirmed centrally.
8.2.1.1
Initial Tumor Imaging
Initial tumor imaging at screening must be performed within 28 days prior to the date of the 
first dose of study intervention.
Tumor imaging performed as part of routine clinical management is acceptable for use as 
screening tumor imaging if it is of diagnostic quality and performed within 28 days prior to
first treatment dose. 
Participants with previously treated brain metastases may participate provided they are 
clinically stable for at least 2 weeks and have no evidence of new or enlarging brain 
metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain 
metastases by this definition should be established prior to the first dose of study medication. 
Participants with known untreated, asymptomatic brain metastases (ie, no neurological 
symptoms, no requirements for corticosteroids, no or minimal surrounding edema, and no 
lesion >1.5 cm) may participate but will require regular imaging of the brain as a site of 
disease. This exception does not include carcinomatous meningitis, as participants with 
carcinomatous meningitis are excluded regardless of clinical stability.
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For participants to proceed to the Maintenance Phase, responses do not need to be confirmed. 
However, images will need to be reviewed centrally to determine that the participants do not 
have progressive disease. Further, if the participant is determined to be eligible for 
maintenance, the latest evaluable imaging time point prior to entering maintenance will serve 
as the new baseline.
During the Maintenance Phase, objective response should be confirmed by a repeat imaging 
assessment. Tumor imaging to confirm PR or CR should be performed at least 4 weeks after 
the first indication of a response is observed. Participants will then return to regular 
scheduled imaging, starting with the next scheduled imaging time point. Participants who 
receive additional imaging for confirmation do not need to undergo the next scheduled tumor 
imaging if it is less than 4 weeks later; tumor imaging may resume at the subsequent 
scheduled imaging time point. Note:  Response does not typically need to be verified in real 
time by the central imaging vendor.
8.2.1.3
End-of-Treatment and Follow-up Tumor Imaging
For randomized participants who discontinue study intervention, tumor imaging should be 
performed at the time of treatment discontinuation (±4 week window). If previous imaging 
was obtained within 4 weeks prior to the date of discontinuation, then imaging at treatment 
discontinuation is not mandatory. For participants who discontinue study intervention due to 
centrally verified disease progression, this is the final required tumor imaging if the 
investigator elects not to implement iRECIST.
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8.2.1.4
Second Course (Retreatment) Tumor Imaging
Tumor imaging must be performed within 28 days prior to restarting treatment with 
pembrolizumab. 
Per iRECIST (Section 8.2.1.6), if tumor imaging shows initial PD, tumor assessment should 
be repeated 4 to 8 weeks later to confirm PD with the option of continuing treatment while 
awaiting radiologic confirmation of progression. Participants who obtain confirmatory 
imaging do not need to undergo scheduled tumor imaging if it is less than 4 weeks later and 
may wait until the next scheduled imaging time point, if clinically stable.
Imaging should continue to be performed until locally verified disease progression, the start 
of a new anticancer treatment, withdrawal of consent, death, or notification by MSD, 
whichever occurs first. In clinically stable participants, disease progression may be 
confirmed by the investigator using iRECIST 4 to 8 weeks after the first tumor imaging 
indicating PD.
For participants who discontinue Second Course study intervention without locally verified
disease progression, every effort should be made to continue monitoring their disease status 
by radiologic imaging every 12 weeks (84 days ±7 days) or as clinically indicated thereafter 
until either the start of a new anticancer treatment, disease progression, death, withdrawal of 
consent, or the end of the study, whichever occurs first.
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8.2.1.5
RECIST 1.1 Assessment of Disease
Upon investigator-assessed disease progression, the indicative scan(s) is/are to be submitted 
immediately to iCRO for BICR verification of progression. After submission of scan(s), the 
iCRO will email the assessment to the site and Sponsor.
If disease progression is not verified, the process continues as follows:
•
If participant is clinically stable, continue study intervention per protocol
-
Continue scans per protocol schedule (the next scheduled scan should be ≥4 
weeks from most recent scan acquired)
-
Send scan(s) to iCRO
-
Continue local assessment
-
Do not change investigator assessment of progression
-
If subsequent scan(s) indicate progression, submit scan(s) to iCRO to request 
verification
•
If the participant is not clinically stable, the best medical practice is to be applied.
Before stopping study intervention or imaging or starting new anticancer therapy in a 
participant who is clinically stable, communication with the Sponsor is required.
If disease progression is centrally verified, the process continues as follows:
•
Investigator judgment will determine action
•
If participant is clinically stable and study intervention is to continue, communication 
with the Sponsor is required and a reconsent addendum must be signed
•
Obtain scan(s) locally per original protocol schedule
•
Do not send scan(s) to iCRO
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Figure 2 illustrates the study intervention decision process involving verification of disease 
progression for participants.
For the purpose of this decision process, lack of clinical stability is defined as:
•
Unacceptable toxicity
•
Clinical signs or symptoms indicating clinically significant disease progression
•
Decline in performance status
•
Rapid disease progression or threat to vital organs or critical anatomical sites (eg, CNS 
metastasis, respiratory failure due to tumor compression, spinal cord compression) 
requiring urgent alternative medical intervention
Figure 2
Study Intervention Decision-making Process When Progression per RECIST 1.1 
is Observed by Investigator
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8.2.1.6
iRECIST Assessment of Disease
iRECIST is based on RECIST 1.1, but it is adapted to account for the unique tumor response 
seen with immunotherapeutic drugs. iRECIST will be used by the investigator to assess 
tumor response and progression and make treatment decisions [Seymour, L., et al 2017]. 
When clinically stable, participants may continue study intervention beyond RECIST 1.1 
progression with continued assessment of response according to the rules outlined in 
Appendix 8. iRECIST reflects that some participants can have a transient tumor flare after 
the start of immunotherapy then experience subsequent disease response. This data will be 
captured in the clinical database.
•
If participant is clinically stable and VOP is not centrally verified (refer to 
Section 8.2.1.5), continue study intervention per protocol
-
Perform scans 4 to 8 weeks after RECIST 1.1 progression
-
Continue investigator assessment per iRECIST
-
Send scans to iCRO
-
If progression is BICR-verified, stop sending scans to iCRO
•
If the participant is not clinically stable, best medical practice is to be applied.
8.3
Safety Assessments
Details regarding specific safety procedures/assessments to be performed in this study are 
provided. 
Planned time points for all safety assessments are provided in the SoA.
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8.3.1
Physical Examinations
At the initial visit, a complete physical examination will be conducted by an investigator or 
medically qualified designee (consistent with local requirements) as per institutional 
standard. Clinically significant abnormal findings should be recorded as medical history.
Height and weight will also be measured and recorded.
A brief directed physical examination will be conducted by an investigator or medically 
qualified designee (consistent with local requirements) per institutional standard prior to trial 
treatment administration and at other times according to the SoA. New clinically significant 
abnormal findings should be recorded as AEs.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses.
8.3.2
Vital Signs
The investigator or qualified designee will take vital signs at screening, prior to the 
administration of each dose of trial treatment and during the follow-up period as specified in 
the Schedule of Activities. Vital signs include temperature, pulse, respiratory rate, and blood 
pressure. Weight will be monitored as per vital signs. Height will be measured at Visit 1 
only.
8.3.3
Electrocardiograms
A standard 12-lead ECG will be performed using local standard procedures. The timing of 
ECG is specified in the schedule of activities in Section 1.3. Clinically significant abnormal 
findings should be recorded as medical history. Additional ECGs may be performed as 
clinically necessary.
8.3.4
Clinical Safety Laboratory Assessments
Refer to Appendix 2 for the list of clinical laboratory tests to be performed and to the SoA for 
the timing and frequency.
•
The investigator or medically qualified designee (consistent with local requirements) 
must review the laboratory report, document this review, and record any clinically 
relevant changes occurring during the study in the AE section of the case report form 
(CRF). The laboratory reports must be filed with the source documents. Clinically 
significant abnormal laboratory findings are those which are not associated with the 
underlying disease, unless judged by the investigator to be more severe than expected for 
the participant's condition.
•
All protocol-required laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the SoA.
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•
If laboratory values from nonprotocol 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 CRF (eg, SLAB).
•
For any laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 30 days after the last dose of study intervention, every 
attempt should be made to perform repeat assessments until the values return to normal or 
baseline or if a new baseline is established as determined by the investigator.
8.3.4.1
Bone Marrow or Blood Cytogenetic Samples
Bone marrow or blood cytogenetic samples may be collected for participants with prolonged 
hematological toxicities as defined in Section 6.6.2.1.
Bone marrow analysis should include an aspirate for cellular morphology, cytogenetic 
analysis and flow cytometry, and a core biopsy for bone marrow cellularity. If it is not 
possible to conduct cytogenetic analysis or flow cytometry on the bone marrow aspirate, then 
attempts should be made to carry out the tests on a blood sample.
8.3.5
Performance Assessments
8.3.5.1
Eastern Cooperative Oncology Group Performance Status
The ECOG Performance Status is standardized criteria to measure how cancer impacts level 
of functioning (performance status) in terms of ability to care for oneself, daily activity, and 
physical ability (walking, working, etc.) with Grades 0 to 5.
The investigator or qualified designee will assess ECOG status at screening, prior to the 
administration of each dose of study intervention and during the follow-up period as 
specified in the SoA (Section 1.3).
8.4
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable 
Safety Events
The definitions of an AE or SAE, as well as the method of recording, evaluating, and 
assessing causality of AE and SAE and the procedures for completing and transmitting AE, 
SAE, and other reportable safety event reports can be found in Appendix 3.
Adverse events, SAEs, and other reportable safety 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 designees are responsible for detecting, documenting, and reporting 
events that meet the definition of an AE or SAE as well as other reportable safety events. 
Investigators remain responsible for following up AEs, SAEs, and other reportable safety 
events for outcome according to Section 8.4.3.
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The investigator, who is a qualified physician, will assess events that meet the definition of 
an AE or SAE as well as other reportable safety events with respect to seriousness, 
intensity/toxicity and causality.
8.4.1
Time Period and Frequency for Collecting AE, SAE, and Other Reportable 
Safety Event Information
All AEs, SAEs, and other reportable safety events that occur after the participant provides 
documented consent but before intervention allocation/randomization must be reported by 
the investigator if the participant is receiving placebo run-in or other run-in treatment, if the 
event cause the participant to be excluded from the study, or is the result of a protocol-
specified intervention, including but not limited to washout or discontinuation of usual 
therapy, diet, or a procedure.
•
All AEs from the time of intervention allocation/randomization through 30 days 
following cessation of study intervention must be reported by the investigator.
•
All AEs meeting serious criteria, from the time of intervention allocation/randomization 
through 90 days following cessation of study intervention or 30 days following cessation 
of study intervention if the participant initiates new anticancer therapy, whichever is 
earlier, must be reported by the investigator.
•
All pregnancies and exposure during breastfeeding, from the time of intervention
allocation/randomization through 120 days following cessation of study intervention, or 
30 days following cessation of study intervention if the participant initiates new 
anticancer therapy must be reported by the investigator.
•
Any SAE of MDS/AML or new primary malignancy should be reported regardless of the 
investigator’s assessment of causality or knowledge of the treatment arm.
•
Additionally, any SAE brought to the attention of an investigator at any time outside of 
the time period specified above must be reported immediately to the Sponsor if the event 
is considered related to study intervention.
Investigators are not obligated to actively seek AEs or SAEs or other reportable safety events 
in former study participants. However, if the investigator learns of any SAE, including a 
death, at any time after a participant has been discharged from the study, and he/she 
considers the event to be reasonably related to the study intervention or study participation, 
the investigator must promptly notify the Sponsor.
All initial and follow-up AEs, SAEs, and other reportable safety events will be recorded and 
reported to the Sponsor or designee within the time frames as indicated in Table 14.
Exception: A positive pregnancy test at the time of initial screening is not a reportable event 
unless the participant has received study intervention.
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Extension Study: Upon study completion, participants are discontinued and may be enrolled 
in a pembrolizumab extension study, if available. From the time of intervention 
randomization through up to documentation of consent to the extension study, all AEs, SAE, 
and other reportable safety events must be reported by the investigator in this protocol
(parent study). Laboratory values that meet criteria for reporting as AEs performed during 
parent study will be collected in the parent study. Once consented to the extension study, 
AEs and other reportable events meeting the criteria of the extension study, including those 
considered related to study intervention, will be collected as instructed in the extension study.
Table 14
Reporting Time Periods and Time Frames for Adverse Events and Other 
Reportable Safety Events
Type of Event
Reporting Time 
Period:
Consent to 
Randomization/ 
Allocation
Reporting Time 
Period:
Randomization/ 
Allocation through 
Protocol-specified 
Follow-up Period
Reporting Time 
Period:
After the Protocol-
specified Follow-
up Period
Time Frame to 
Report Event 
and Follow-up 
Information to 
Sponsor:
Nonserious 
Adverse Event
(NSAE)
Report if:
- due to protocol-
specified intervention
- causes exclusion
- participant is 
receiving placebo run-
in or other run-in 
treatment
Report all
Not required
Per data entry 
guidelines
Serious Adverse 
Event (SAE)
including Cancer 
and Overdose
Report if:
- due to protocol-
specified intervention
- causes exclusion
- participant is 
receiving placebo run-
in or other run-in 
treatment
Report all
Report if:
- drug/vaccine 
related.
(Follow ongoing to 
outcome)
Within 24 hours 
of learning of 
event
Pregnancy/
Lactation Exposure
Report if:
- participant has been 
exposed to any 
protocol-specified 
intervention (eg, 
procedure, washout or 
run-in treatment 
including placebo run-
in)
Exception: A positive 
pregnancy test at the 
time of initial 
screening is not a 
reportable event.
Report all
Previously reported 
– Follow to 
completion/
termination; report 
outcome
Within 24 hours 
of learning of 
event
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Type of Event
Reporting Time 
Period:
Consent to 
Randomization/ 
Allocation
Reporting Time 
Period:
Randomization/ 
Allocation through 
Protocol-specified 
Follow-up Period
Reporting Time 
Period:
After the Protocol-
specified Follow-
up Period
Time Frame to 
Report Event 
and Follow-up 
Information to 
Sponsor:
Event of Clinical 
Interest (require 
regulatory
reporting)
Report if:
- due to intervention
- causes exclusion
Report
- potential drug-
induced liver injury 
(DILI)
- require regulatory 
reporting
Not required
Within 24 hours 
of learning of 
event
Event of Clinical 
Interest (do not 
require regulatory
reporting)
Report if:
- due to intervention
- causes exclusion
Report
- non-DILI ECIs and 
those not requiring 
regulatory reporting
Not required
Within 5 
calendar days of 
learning of event
8.4.2
Method of Detecting AEs, SAEs, and Other Reportable Safety Events
Care will be taken not to introduce bias when detecting AEs and/or SAEs and other 
reportable safety events. Open-ended and nonleading verbal questioning of the participant is 
the preferred method to inquire about AE occurrence.
8.4.3
Follow-up of AE, SAE, and Other Reportable Safety Event Information
After the initial AE/SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. All AEs, SAEs, and other reportable safety events 
including pregnancy and exposure during breastfeeding, events of clinical interest (ECIs), 
cancer, and overdose will be followed until resolution, stabilization, until the event is 
otherwise explained, or the participant is lost to follow-up (as defined in Section 7.3). In 
addition, the investigator will make every attempt to follow all nonserious AEs that occur in 
randomized participants for outcome. Further information on follow-up procedures is given 
in Appendix 3.
8.4.4
Regulatory Reporting Requirements for SAE
Prompt notification (within 24 hours) by the investigator to the Sponsor of SAE is essential 
so that legal obligations and ethical responsibilities toward the safety of participants and the 
safety of a study intervention under clinical investigation are met.
The Sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
Sponsor will comply with country-specific regulatory requirements and global laws and 
regulations relating to safety reporting to regulatory authorities, IRB/IECs, and investigators.
Investigator safety reports must be prepared for suspected unexpected serious adverse 
reactions (SUSARs) according to local regulatory requirements and Sponsor policy and 
forwarded to investigators as necessary.
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An investigator who receives an investigator safety report describing an SAE or other 
specific safety information (eg, summary or listing of SAE) from the Sponsor will file it 
along with the IB and will notify the IRB/IEC, if appropriate according to local requirements.
8.4.5
Pregnancy and Exposure During Breastfeeding
Although pregnancy and infant exposure during breastfeeding are not considered AEs, any 
pregnancy or infant exposure during breastfeeding in a participant (spontaneously reported to 
the investigator or their designee) that occurs during the study are reportable to the Sponsor.
All reported pregnancies must be followed to the completion/termination of the pregnancy.
Any pregnancy complication will be reported as an AE or SAE.
The medical reason (example: maternal health or fetal disease) for an elective termination of 
a pregnancy will be reported as an AE or SAE. Prenatal testing showing fetus will be born 
with severe abnormalities/congenital anomalies that leads to an elective termination of a 
pregnancy will be reported as an SAE for the fetus.
Pregnancy outcomes of ectopic pregnancy, spontaneous abortion, missed abortion, benign 
hydatidiform mole, blighted ovum, fetal death, intrauterine death, miscarriage, and stillbirth 
must be reported as serious events (Important Medical Events). If the pregnancy continues to 
term, the outcome (health of infant) must also be reported.
8.4.6
Disease-related Events and/or Disease-related Outcomes Not Qualifying as 
AEs or SAEs
Efficacy endpoints as outlined in this section will not be reported to the Sponsor as described 
in Section 8.4.1.
Specifically, the suspected/actual events covered in this exception include any event that is 
disease progression of the cancer under study.
The Sponsor will monitor unblinded aggregated efficacy endpoint events and safety data to 
ensure the safety of the participants in the study.
8.4.7
Events of Clinical Interest (ECIs)
Selected nonserious and SAEs are also known as ECIs and must be reported to the Sponsor. 
Events of clinical interest for this study include: 
1. An overdose of Sponsor's products, as defined in Section 8.5, that is not associated with 
clinical symptoms or abnormal laboratory results.
2. An elevated AST or ALT lab value that is greater than or equal to 3X the upper limit of 
normal and an elevated total bilirubin lab value that is greater than or equal to 2X the 
upper limit of normal and, at the same time, an alkaline phosphatase lab value that is less 
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than 2X the upper limit of normal, as determined by way of protocol-specified laboratory 
testing or unscheduled laboratory testing.* 
*Note: These criteria are based upon available regulatory guidance documents. The 
purpose of the criteria is to specify a threshold of abnormal hepatic tests that may require 
an additional evaluation for an underlying etiology. The study site guidance for 
assessment and follow up of these criteria can be found in the Investigator Study File 
Binder (or equivalent).
3. Any event of MDS/AML, new primary malignancy, or pneumonitis should be reported 
whether it is considered a nonserious AE (eg, non-melanoma skin cancer) or SAE and 
regardless of Investigator’s assessment of causality.
8.5
Treatment of Overdose
Olaparib must only be used in accordance with the dosing recommendations in this protocol. 
Any dose or frequency of dosing that exceeds the dosing regimen specified in this protocol 
should be reported as an overdose. For this study, an overdose of pembrolizumab will be 
defined as any dose of 1000 mg or greater (≥5 times the indicated dose). 
No specific information is available on the treatment of overdose of olaparib or 
pembrolizumab. In the event of overdose, the study intervention should be discontinued, and 
the participant should be observed closely for signs of toxicity. Appropriate supportive 
treatment should be provided if clinically indicated.
8.6
Pharmacokinetics
PK parameters will not be evaluated in this study.
8.7
Pharmacodynamics
Pharmacodynamic parameters will not be evaluated in this study.
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8.12
Visit Requirements
Visit requirements are outlined in Section 1.3. Specific procedure-related details are provided 
in Section 8.
8.12.1
Screening
Approximately 28 days prior to treatment allocation, potential participants will be evaluated 
to determine that they fulfill the entry requirements as set forth in Section 5. 
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Documented informed consent must be provided before performing any protocol-specific 
procedure. Results of a test performed prior to the participant signing consent as part of 
routine clinical management are acceptable in lieu of a screening test if performed within the 
specified time frame. Screening procedures are to be completed within 28 days prior to the 
first dose of study treatment except for the following:
•
Laboratory tests are to be performed within 10 days prior to the first dose of study 
intervention. An exception is hepatitis and HIV testing which may be done up to 28 days 
prior to the first dose of study intervention if required by the local health authority.
•
Evaluation of ECOG is to be performed within 7 days prior to the first dose of study 
intervention.
•
For WOCBP, a urine pregnancy test will be performed within 72 hours prior to the first 
dose of study treatment. If urine pregnancy results cannot be confirmed as negative, a 
serum pregnancy test will be required (performed by the local trial site laboratory). 
Additional pregnancy testing can be conducted if required by local regulations or 
clinically indicated.
Participants may be rescreened after initially failing to meet the inclusion/exclusion criteria. 
Results from assessments during the initial screening period are acceptable in lieu of a repeat 
screening test if performed within the specified time frame and the corresponding 
inclusion/exclusion criteria is met. Participants who are rescreened will retain their original 
screening number. Rescreening is permitted as long as the study is open for enrollment.
8.12.2
Pre-randomization Visit
All participants will be evaluated at a Pre-Randomization visit, which will occur 4 weeks (±7 
days) after Cycle 4, Day 1 of treatment in the Induction Phase and prior to study 
procedures/intervention in the Maintenance Phase. Investigators will review 
inclusion/exclusion criteria to ensure eligibility. A checklist will be completed and must be 
reviewed and approved by Sponsor. 
Participants with PD must be excluded from the Maintenance Phase and should enter End-of-
Treatment (refer to Section 1.3.2). 
8.12.3
Treatment Period
Visit requirements are outlined in the SoA (Section 1.3). Specific procedure-related details 
are provided in Section 8.1. Assessments/procedures should be performed prior to the 
administration of study intervention.
8.12.4
Participants Discontinued From Study Intervention but Continuing to be 
Monitored in the Study
Randomized participants who discontinue study treatment for reasons other than PD, will 
move into the Follow-up Phase (Section 8.12.6).
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8.12.5
Second Course Phase (Retreatment Period)
Note: Participants are allowed to start Second Course Treatment with locally verified PD. 
Original protocol text has been retained for reference.
All participants who receive 35 cycles of pembrolizumab with SD, PR, or CR in either arm 
may be eligible for up to an additional year of treatment with pembrolizumab (17 cycles) if 
they progress after stopping study treatment from the initial treatment period. This 
retreatment is termed the Second Course Phase of this study and is only available if the study
remains open and the participant meets the following conditions:
•
Experienced radiographic disease progression by RECIST 1.1 after stopping initial 
treatment with pembrolizumab, and
•
No new anticancer treatment was administered after the last dose of study intervention, 
and
•
The participant meets all of the safety parameters listed in the inclusion criteria and none 
of the safety parameters listed in the exclusion criteria, and
•
The study is ongoing.
•
AND Had SD, PR or CR and stopped pembrolizumab treatment after completion of 
35 administrations (approximately 2 years) of study intervention for reasons other than 
disease progression or intolerability.
An objective response or disease progression that occurs during the Second Course Phase for 
a participant will not be counted as an event for the primary analysis of either endpoint in this 
study.
Procedures and visit requirements for the Second Course Phase are outlined in Section 1.3.4.
8.12.6
Posttreatment Visits
8.12.6.1
Safety Follow-up Visit
The mandatory Safety Follow-up Visit should be conducted approximately 30 days after the 
last dose of study treatment in the Induction Phase or the Maintenance Phase. Participants 
who are eligible for retreatment with pembrolizumab may have up to 2 safety follow-up 
visits, 1 after the Initial Treatment Period and 1 after the Second Course Treatment Phase.
8.12.6.2
Follow-up Visits
Randomized participants who discontinue study treatment for a reason other than PD will 
move into the Long-term Follow-up Phase and should be assessed approximately Q6W 
(42 days ± 7 days) during the first 48 weeks following randomization and approximately 
Q9W (63 days ± 7 days) thereafter. Every effort should be made to collect information 
regarding disease status until confirmed PD, start of a new anticancer therapy, death, 
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withdrawal of consent, or the end of the study, whichever occurs first. Information regarding 
poststudy anticancer treatment will be collected if new treatment is initiated.
8.12.6.3
Imaging Follow-up Visits
All randomized participants who discontinue study intervention prior to disease progression 
will continue to undergo tumor assessments as per SoA (see Section 1.3.2) until centrally 
verified disease progression is documented and confirmed by BICR or a new anticancer 
therapy is initiated, unless the participant withdraws consent. 
Participants who are eligible for retreatment with pembrolizumab according to the criteria in 
Section 8.12.5 will move from the Follow-Up Phase to the Second Course Phase when they 
experience disease progression. Details are provided in the SoA (Section 1.3.4) for 
retreatment with pembrolizumab.
8.12.6.4
Survival Follow-up Assessments
Randomized participants follow-up status will be assessed approximately every 12 weeks to 
assess for survival status until death, withdrawal of consent, or the end of the study, 
whichever occurs first. 
The first survival follow-up assessment should be scheduled as described below:
1. For participants who discontinue treatment intervention and who will not enter the 
Efficacy Follow-up Phase, the first survival follow-up contact will be scheduled 
12 weeks after the Discontinuation Visit and/or Safety Follow-up Visit (whichever is 
last).
2. For participants who completed assessments in the Efficacy Follow-up Phase, the first 
survival follow-up contact will be scheduled 12 weeks after the last efficacy assessment 
follow-up visit has been performed.
8.12.7
Vital Status
To ensure current and complete survival information (vital status) is available at the time of 
database locks, updated vital status may be requested during the course of the study by the 
Sponsor. For example, updated vital status may be requested before, but not limited to, an 
eDMC review, interim and/or final analysis. Upon Sponsor notification, all randomized 
participants who do not/will not have a scheduled study visit or study contact during the 
Sponsor-defined time period will be contacted for their vital status.
9
STATISTICAL ANALYSIS PLAN
As of Amendment 07: The Statistical Analysis Plan is amended as follows.
Note: Based on the data from an interim safety and efficacy analysis (IA3) for MK-7339-008 
(data cutoff 21-SEP-2023), the final analysis will not take place. It has been determined that 
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it was extremely unlikely that the efficacy boundary for success for the primary endpoint of 
OS would be reached at the next (final) analysis. 
Based upon these data and the recommendation of the eDMC, the study was unblinded. The 
prespecified final analysis of the study described in the SAP will not be performed. Selected 
analyses of safety endpoints will be performed at the end of the study; there will be no 
further analyses of efficacy and ePRO endpoints.
This section outlines the statistical analysis strategy and procedures for the study. If, after the 
study has begun, changes made to primary and/or key secondary hypotheses, or the statistical 
methods related to those hypotheses, then the protocol will be amended (consistent with ICH 
Guideline E-9). Changes to exploratory or other non-confirmatory analyses made after the 
protocol has been finalized, will be documented in a supplemental Statistical Analysis Plan 
(sSAP) and referenced in the Clinical Study Report (CSR) for the study. Post hoc exploratory 
analyses will be clearly identified in the CSR. Separate analysis plans (ie, separate 
documents from the sSAP) may be developed to detail other planned analyses (ie, analysis of 
future biomedical research). The PRO analysis plan will be included in the sSAP.
9.1
Statistical Analysis Plan Summary
Note: As of Amendment 07, the prespecified final analysis of the study described in the SAP 
will not be performed. Selected analyses of safety endpoints will be performed at the end of 
the study; there will be no further analyses of efficacy and PRO endpoints. The SAP 
summary has been updated accordingly.
Key elements of the Statistical Analysis Plan are summarized below; the comprehensive plan 
is provided in Sections 9.2 to 9.12.  
Study Design Overview
A Phase 3 Study of Pembrolizumab in Combination with 
Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by 
Pembrolizumab with or without Maintenance Olaparib in the First-Line 
Treatment of Metastatic Squamous Non-Small Cell Lung Cancer 
(NSCLC)
Treatment Assignment
After completing the Induction Phase of treatment with pembrolizumab 
in combination with carboplatin with taxane (paclitaxel/nab-paclitaxel), 
approximately 590 eligible participants will be randomized in a 1:1 
ratio to receive pembrolizumab plus maintenance olaparib or 
pembrolizumab plus maintenance olaparib placebo. 
Stratification factors are as follows:
•
PD-L1 TPS <50% vs ≥50%
•
Response at randomization CR/PR vs SD 
•
ECOG 0 vs 1 at Pre-randomization Visit
This is a randomized double-blind study.
Analysis Populations
Efficacy: Intention-to-Treat (ITT)
Safety: All Participants as Treated (APaT)
PROs: Full Analysis Set (FAS)
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Primary Endpoint(s)
•
Progression-free Survival (PFS) per RECIST 1.1 (Section 
4.2.1.1) assessed by BICR 
•
Overall survival (OS)
Secondary Endpoints
•
Safety and tolerability
•
Patient-report outcomes
Statistical Methods for Key 
Efficacy Analyses
The dual primary hypotheses on PFS and OS will be evaluated by 
comparing pembrolizumab plus maintenance olaparib to pembrolizumab
plus placebo in Maintenance Phase using a stratified Log-rank test. The 
hazard ratio will be estimated using a stratified Cox regression model. 
Event rates over time will be estimated within each treatment group using 
the Kaplan-Meier method. 
Statistical Methods for Key 
Safety Analyses
The analysis of safety results in the APaT will follow a tiered approach. 
There are no Tier 1 safety parameters in this trial. All safety parameters 
are considered either Tier 2 or Tier 3. Tier 2 parameters will be 
assessed via point estimates with 95% confidence intervals provided for 
between-group comparisons; only point estimates by treatment group 
are provided for Tier 3 safety parameters. The between-treatment 
difference will be analyzed using the Miettinen and Nurminen method
[Miettinen, O. and Nurminen, M. 1985].
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9.2
Responsibility for Analyses/In-house Blinding
The statistical analysis of the data obtained from this study will be the responsibility of the 
Clinical Biostatistics department of the Sponsor.
This study will be conducted as a double-blinded study under in-house blinding procedures. 
The official, final database will not be unblinded until medical/scientific review has been 
performed, protocol deviations have been identified, and data have been declared final and 
complete.
The Sponsor will generate the randomized allocation schedule(s) for study treatment 
assignment for this protocol, and the randomization will be implemented in IRT.
Blinding issues related to the planned interim analyses are described in Section 9.7.  
9.3
Hypotheses/Estimation
Objectives and hypotheses of the study are stated in Section 3.
9.4
Analysis Endpoints
Efficacy and safety endpoints that will be evaluated for within- and/or between-treatment 
differences are listed below. Exploratory endpoints will be described in the sSAP.
9.4.1
Efficacy Endpoints
Dual Primary
Progression-free survival (PFS) – RECIST 1.1 assessed by BICR 
Progression-free-survival (PFS) is defined as the time from randomization to the first 
documented disease progression per RECIST 1.1 (Section 4.2.1.1) based on blinded 
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independent central imaging vendor review or death due to any cause, whichever occurs first. 
See Section 9.6.1 for the censoring rules.
Overall Survival
Overall Survival (OS) is defined as the time from randomization to death due to any cause. 
Participants without documented death at the time of analysis will be censored at the last date 
known to be alive.
9.4.2
Safety Endpoints
Safety measurements are described in Section 4.2.1.2, and Section 8.3 and Section 8.4.
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9.6
Statistical Methods
9.6.1
Statistical Methods for Efficacy Analyses
Note: As of Amendment 07, the prespecified final analysis of the study described in the SAP 
will not be performed. Selected analyses of safety endpoints will be performed at the end of 
the study; there will be no further analyses of efficacy and PRO endpoints. The subsections 
below are retained for reference.
This section describes the statistical methods that address the primary objectives. Methods 
related to exploratory objectives will be described in the supplemental SAP.
Efficacy results that will be deemed to be statistically significant after consideration of the 
Type I error control strategy are described in Section 9.8. Nominal p values will be computed 
for other efficacy analyses but should be interpreted with caution due to potential issues of 
multiplicity. Response or progression in the Second Course Phase will not count toward the 
PFS of the primary endpoint in this trial.
The stratification factors used for randomization (see Section 6.3.2) will be applied to all 
stratified analyses, in particular, the stratified log-rank test, stratified Cox model, and 
stratified Miettinen and Nurminen method [Miettinen, O. and Nurminen, M. 1985a]. In the 
event that there are small strata, for the purpose of analysis, strata will be combined to ensure 
sufficient number of participants, responses and events in each stratum. Details regarding the 
pooling strategy will be prespecified in the sSAP.
9.6.1.1
Progression-free Survival
The non-parametric Kaplan-Meier method will be used to estimate the PFS curve in each 
treatment group. The treatment difference in PFS will be assessed by the stratified log-rank 
test (based on the stratification factors defined in Section 6.3.2). A stratified Cox proportional 
hazard model with Efron's method of tie handling will be used to assess the magnitude of the 
treatment difference (ie, hazard ratio) between the treatment arms. The hazard ratio and its 
95% confidence interval from the stratified Cox model with Efron's method of tie handling 
and with a single treatment covariate will be reported. The stratification factors used for 
randomization (See Section 6.3.2) will be applied to both the stratified log-rank test and the 
stratified Cox model. 
Since disease progression is assessed periodically, PD can occur any time in the time interval 
between the last assessment where PD was not documented and the assessment when PD is 
documented. The true date of disease progression will be approximated by the date of the 
first assessment at which PD is objectively documented per RECIST 1.1 via BICR by the 
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imaging vendor. Death is always considered as a confirmed PD event. Participants who do 
not experience a PFS event will be censored at the last disease assessment. Sensitivity 
analyses will be performed for comparison of PFS based on investigator's assessment.
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9.6.1.2
Overall Survival (OS)
The non-parametric Kaplan-Meier method will be used to estimate the survival curves. The 
treatment difference in survival will be assessed by the stratified log-rank test (based on the 
stratification factor defined in Section 6.3.2). A stratified Cox proportional hazard model 
with Efron's method of tie handling will be used to assess the magnitude of the treatment 
difference (ie, the hazard ratio). The hazard ratio and its 95% confidence interval from the 
stratified Cox model with a single treatment covariate will be reported. The stratification 
factors used for randomization (See Section 6.3.2) will be applied to both the stratified log-
rank test and the stratified Cox model. Participants without documented death at the time of 
analysis will be censored at the date of last known to be alive. 
The RMST method may be conducted for OS as a sensitivity analysis to account for the 
possible non-proportional hazards effect and to estimate the absolute benefit of experimental 
treatment. 
9.6.1.3
Analysis Strategy for Key Efficacy Endpoints 
The primary analysis approach for the primary and key secondary efficacy endpoints are 
summarized in Table 16. Sensitivity analysis methods are described above for each endpoint 
as applicable.
The strategy to address multiplicity issues with regard to multiple efficacy endpoints, and 
interim analyses is described in Section 9.7, Interim Analyses and in Section 9.8,
Multiplicity.
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Table 16
Analysis Strategy for Key Efficacy Variables
Endpoint/Variable
(Description, Time Point) 
Statistical Methoda
Analysis 
Population
Missing Data Approach
Dual Primary Endpoints
PFS per RECIST 1.1 by 
blinded independent central 
review (BICR) by the imaging 
vendor
Test: Stratified Log-rank 
test to assess the treatment 
difference
Estimation: Stratified Cox 
model with Efron’s tie 
handling method to assess 
the magnitude of treatment 
difference
ITT
Primary censoring rule
Sensitivity analysis 1
Sensitivity analysis 2
OS
Test: Stratified Log-rank 
test to assess the treatment 
difference
Estimation: Stratified Cox 
model with Efron’s tie 
handling method to assess 
the magnitude of treatment 
difference
ITT
Model based
(censored at the last 
date the participant 
was known to be alive)
a
Statistical models are described in further detail in the text. For stratified analyses, the stratification factors used for 
randomization (Section 6.3.2) will be applied to the analysis.
Abbreviations: ITT=intention-to-treat; OS=overall survival; PFS=progression-free survival; RECIST 1.1=Response 
Evaluation Criteria in Solid Tumors 1.1; 
9.6.2
Statistical Methods for Safety Analyses
Adverse events occurring in participants treated during the induction phase will be collected 
and reported, which will be detailed in the sSAP.
Safety and tolerability will be assessed by clinical review of all relevant parameters including 
AEs, laboratory tests, vital signs, and ECG measurements after randomization. The analysis 
of safety results in the APaT will follow a tiered approach (Table 17). The tiers differ with 
respect to the analyses that will be performed. Adverse experiences (specific terms as well as 
system organ class terms) and events that meet predefined limits of change in laboratory and
vital signs parameters are either prespecified as Tier-1 endpoints or will be classified as 
belonging to “Tier 2” or “Tier 3”, based on the number of events observed. 
Tier 1 Events
Safety parameters or adverse experiences of special interest that are identified a priori 
constitute “Tier 1” safety endpoints that will be participant to inferential testing for statistical 
significance with p values and 95% confidence intervals to be provided for between-
treatment comparisons. Those AEOSIs that are immune-mediated or potentially immune-
mediated are well documented and will be separately evaluated; however, these events have 
been consistently characterized throughout the pembrolizumab clinical development 
program, and determination of statistical significance is not expected to add value to the 
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safety evaluation. In addition, there are no known AEs associated with participants with 
NSCLC for which determination of a p-value is expected to impact the safety assessment. 
Thus, there are no AEs that warrant elevation to Tier 1 in this study.
Tier 2 Events
Tier 2 parameters will be assessed via point estimates with 95% confidence intervals 
provided for between-treatment differences in the proportion of participants with events
using the Miettinen and Nurminen method [Miettinen, O. and Nurminen, M. 1985], an 
unconditional, asymptotic method. 
Membership in Tier 2 requires that at least 10% of participants in any treatment group exhibit 
the event. The threshold of at least 10% participants was chosen because the patient
population enrolled in this study are in critical conditions and usually experience various 
adverse events of similar types regardless of treatment, events reported less frequent than 
10% of participants would obscure the assessment of overall safety profile and add little to 
the interpretation of potentially meaningful treatment differences. In addition, Grade 3 to 5 
AE (≥5% of participants in one of the treatment groups) and SAE (≥5% of participants in one 
of the treatment groups) will be considered Tier 2 endpoints. Because many 95% confidence 
intervals may be provided without adjustment for multiplicity, the confidence intervals 
should be regarded as a helpful descriptive measure to be used in review, not a formal 
method for assessing the statistical significance of the between-group differences in adverse 
experiences and safety parameters that meet predefined limits of change.
Tier 3 Events
Safety endpoints that are not Tier 1 or 2 events are considered Tier 3 events. Only point 
estimates by treatment group are provided for Tier 3 safety parameters.
Continuous Safety Measures 
For continuous measures such as changes from baseline in laboratory and vital signs and 
ECG parameters that are not prespecified as Tier 1 endpoints will be considered Tier 3 safety 
parameters. Summary statistics for baseline, on treatment, and change from baseline values 
will be provided by treatment group in table format. 
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Table 17
Analysis Strategy for Safety Parameters
Safety 
Tier
Safety Endpoint
95% CI for 
Treatment
Comparison
Descriptive 
Statistics
Tier 2
Any AE (≥10% of participants in one of the treatment arms)
X
X
Any Serious AE (≥5% of participants in one of the treatment arms)
X
X
Any Grade 3-5 AE (≥5% of participants in one of the treatment arms)
X
X
Tier 3
AEs, Specific AEs, SOCs
-
X
Discontinuation due to AE
-
X
Dose interruption due to AE
-
X
Change from Baselinea Results (Labs, ECGs, Vital Signs)
-
X
Abbreviations: AE=adverse event; CI=confidence interval; ECG=electrocardiogram; PDLC=predefined limit of change; 
SOC= system organ class. 
a The baseline value is defined as last available measurement on or before the first study intervention during Maintenance 
Phase.
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9.6.4
Summaries of Baseline Characteristics, Demographics, and Other Analyses
9.6.4.1
Demographic and Baseline Characteristics
The comparability of the treatment groups for each relevant demographic and baseline
characteristic will be assessed using tables and/or graphs (ie, baseline values will be the last 
available measurement on or before randomization). No statistical hypothesis tests will be 
performed on these characteristics. The number and percentage of participants screened, 
randomized, the primary reasons for screening failure, and the primary reason for 
discontinuation will be displayed. Demographic variables (eg, age, gender), baseline 
characteristics, and prior and concomitant therapies will be summarized by treatment either 
by descriptive statistics or categorical tables.
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9.8
Multiplicity
Note: As of Amendment 07, the prespecified final analysis of the study described in the SAP 
will not be performed. This section is retained for reference.
The trial uses the graphical method of Maurer and Bretz [Bretz, F., et al 2011] to provide 
strong multiplicity control for multiple hypotheses as well as interim analyses. According to 
Maurer and Bretz approach, study hypotheses may be tested more than once, and when a 
particular null hypothesis is rejected, the α allocated to that hypothesis can be reallocated to 
other hypothesis tests. 
 
 
CCI
CCI
CCI
CCI
CCI
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CCI
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CCI
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9.8.3
Safety Analyses
The external DMC has responsibility for assessment of overall risk:benefit. When prompted 
by safety concerns, the external DMC can request corresponding efficacy data. External 
DMC review of efficacy data to assess the overall risk:benefit to study participants will not 
require a multiplicity adjustment typically associated with a planned efficacy interim 
analysis. However, to account for any multiplicity concerns raised by the external DMC 
review of unplanned efficacy data prompted by safety concerns, a sensitivity analysis for 
efficacy endpoints adopting a conservative multiplicity adjustment will be prespecified in the 
sSAP. This analysis will be performed if requested by the external DMC.
9.9
Sample Size and Power Calculations
Note: As of Amendment 07, the prespecified final analysis of the study described in the SAP 
will not be performed. This section is retained for reference.
The study will randomize approximately 590 participants in a 1:1 ratio into the 2 study 
interventions, pembrolizumab combined with maintenance olaparib and pembrolizumab 
combined with placebo. PFS and OS are dual primary endpoints for the study.
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9.11
Compliance (Medication Adherence)
Drug accountability data for study intervention will be collected during the study. Any 
deviation from protocol-directed administration will be reported.
9.12
Extent of Exposure
The extent of exposure will be summarized as duration of treatment in cycles. Summary 
statistics will be provided on extent of exposure for the APaT population.
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10
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS
10.1
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1
Code of Conduct for Clinical Trials
Merck Sharp & Dohme LLC, Rahway, NJ, USA (MSD)
Code of Conduct for Interventional Clinical Trials
I. Introduction
A. Purpose
MSD, through its subsidiaries, conducts clinical trials worldwide to evaluate the safety and effectiveness of our 
products. As such, we are committed to designing, implementing, conducting, analyzing and reporting these trials 
in compliance with the highest ethical and scientific standards. Protection of participants in clinical trials is the 
overriding concern in the design of clinical trials. In all cases, MSD clinical trials will be conducted in compliance 
with local and/or national regulations (eg, International Council for Harmonisation Good Clinical Practice [ICH-
GCP]) and in accordance with the ethical principles that have their origin in the Declaration of Helsinki.
B. Scope
Highest ethical and scientific standards shall be endorsed for all clinical interventional investigations sponsored by 
MSD irrespective of the party (parties) employed for their execution (eg, contract research organizations, 
collaborative research efforts). This Code is not intended to apply to trials that are observational in nature, or 
which are retrospective. Further, this Code does not apply to investigator-initiated trials, which are not under the 
full control of MSD.
II. Scientific Issues
A. Trial Conduct
1. Trial Design
Except for pilot or estimation trials, clinical trial protocols will be hypothesis-driven to assess safety, efficacy 
and/or pharmacokinetic or pharmacodynamic indices of MSD or comparator products. Alternatively, MSD 
may conduct outcomes research trials, trials to assess or validate various endpoint measures, or trials to 
determine patient preferences, etc.
The design (ie, participant population, duration, statistical power) must be adequate to address the specific 
purpose of the trial and shall respect the data protection rights of all participants, trial site staff and, where 
applicable, third parties. All trial protocols are and will be assessed for the need and capability to enroll 
underrepresented groups. Participants must meet protocol entry criteria to be enrolled in the trial. 
2. Site Selection
MSD’s clinical trials are conducted globally in many different countries and in diverse populations, including 
people of varying age, race, ethnicity, gender, and accounting for other potential disease related factors. MSD 
selects investigative sites based on medical expertise, access to appropriate participants, adequacy of facilities 
and staff, previous performance in clinical trials, as well as budgetary considerations. Prior to trial initiation, 
sites are evaluated by MSD personnel (or individuals acting on behalf of MSD) to assess the ability to 
successfully conduct the trial.
Where appropriate, and in accordance with regulatory authority guidance, MSD will make concerted efforts 
to raise awareness of clinical trial opportunities in various communities. MSD will seek to engage 
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underrepresented groups and those disproportionately impacted by the disease under study. MSD will support 
clinical trial investigators to enroll underrepresented groups and expand access to those who will ultimately 
use the products under investigation.
3. Site Monitoring/Scientific Integrity
Investigative trial sites are monitored to assess compliance with the trial protocol and general principles of 
Good Clinical Practice (GCP). MSD reviews clinical data for accuracy, completeness, and consistency. Data 
are verified versus source documentation according to standard operating procedures. Per MSD policies and 
procedures, if fraud, scientific/research misconduct, or serious GCP-noncompliance is suspected, the issues 
are investigated. When necessary, the clinical site will be closed, the responsible regulatory authorities and 
ethics review committees notified.
B. Publication and Authorship
Regardless of trial outcome, MSD commits to publish primary and secondary results of its registered trials of 
marketed products in which treatment is assigned, according to the prespecified plans for data analysis. To the 
extent scientifically appropriate, MSD seeks to publish the results of other analyses it conducts that are important 
to patients, physicians, and payers. Some early phase or pilot trials are intended to be hypothesis-generating rather 
than hypothesis testing, in such cases, publication of results may not be appropriate since the trial may be 
underpowered and the analyses complicated by statistical issues such as multiplicity.
MSD’s policy on authorship is consistent with the recommendations published by the International Committee of 
Medical Journal Editors (ICMJE). In summary, authorship should reflect significant contribution to the design and 
conduct of the trial, performance or interpretation of the analysis, and/or writing of the manuscript. All named 
authors must be able to defend the trial results and conclusions. MSD funding of a trial will be acknowledged in 
publications.
III. Participant Protection
A. Ethics Committee Review (Institutional Review Board [IRB]/Independent Ethics Committee [IEC])
All clinical trials will be reviewed and approved by an IRB/IEC before being initiated at each site. Significant 
changes or revisions to the protocol will be approved by the ethics committee prior to implementation, except 
changes required urgently to protect participant safety that may be enacted in anticipation of ethics committee 
approval. For each site, the ethics committee and MSD will approve the participant informed consent form.
B. Safety
The guiding principle in decision-making in clinical trials is that participant welfare is of primary importance. 
Potential participants will be informed of the risks and benefits of, as well as alternatives to, trial participation. At 
a minimum, trial designs will take into account the local standard of care.
All participation in MSD clinical trials is voluntary. Participants enter the trial only after informed consent is 
obtained. Participants may withdraw from an MSD trial at any time, without any influence on their access to, or 
receipt of, medical care that may otherwise be available to them.
C. Confidentiality
MSD is committed to safeguarding participant confidentiality, to the greatest extent possible. Unless required by 
law, only the investigator, Sponsor (or representative), ethics committee, and/or regulatory authorities will have 
access to confidential medical records that might identify the participant by name.
D. Genomic Research
Genomic research will only be conducted in accordance with a protocol and informed consent authorized by an 
ethics committee.
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IV. Financial Considerations
A. Payments to Investigators
Clinical trials are time- and labor-intensive. It is MSD’s policy to compensate investigators (or the sponsoring 
institution) in a fair manner for the work performed in support of MSD trials. MSD does not pay incentives to 
enroll participants in its trials. However, when enrollment is particularly challenging, additional payments may be 
made to compensate for the time spent in extra recruiting efforts.
MSD does not pay for participant referrals. However, MSD may compensate referring physicians for time spent 
on chart review to identify potentially eligible participants.
B. Clinical Research Funding
Informed consent forms will disclose that the trial is sponsored by MSD and that the investigator or sponsoring 
institution is being paid or provided a grant for performing the trial. However, the local ethics committee may 
wish to alter the wording of the disclosure statement to be consistent with financial practices at that institution. As 
noted above, all publications resulting from MSD trials will indicate MSD as a source of funding.
C. Funding for Travel and Other Requests
Funding of travel by investigators and support staff (eg, to scientific meetings, investigator meetings, etc.) will be 
consistent with local guidelines and practices.
V. Investigator Commitment
Investigators will be expected to review MSD’s Code of Conduct as an appendix to the trial protocol, and in signing the 
protocol, agree to support these ethical and scientific standards.
10.1.2
Financial Disclosure
Financial Disclosure requirements are outlined in the US Food and Drug Administration 
Regulations, Financial Disclosure by Clinical Investigators (21 CFR Part 54). It is the 
Sponsor's responsibility to determine, based on these regulations, whether a request for 
Financial Disclosure information is required. It is the investigator's/subinvestigator's 
responsibility to comply with any such request.
The investigator/subinvestigator(s) agree, if requested by the Sponsor in accordance with 21 
CFR Part 54, to provide his/her financial interests in and/or arrangements with the Sponsor to 
allow for the submission of complete and accurate certification and disclosure statements. 
The investigator/subinvestigator(s) further agree to provide this information on a 
Certification/Disclosure Form, commonly known as a financial disclosure form, provided by 
the Sponsor. The investigator/subinvestigator(s) also consent to the transmission of this 
information to the Sponsor in the United States for these purposes. This may involve the 
transmission of information to countries that do not have laws protecting personal data.
10.1.3
Data Protection
Participants will be assigned a unique identifier by the Sponsor. Any participant records or 
datasets that are transferred to the Sponsor will contain the identifier only; participant names 
or any information that would make the participant identifiable will not be transferred.
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The participant must be informed that his/her personal study-related data will be used by the 
Sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant. 
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.
10.1.3.1
Confidentiality of Data
By signing this protocol, the investigator affirms to the Sponsor that information furnished to 
the investigator by the Sponsor will be maintained in confidence, and such information will 
be divulged to the IRB, IEC, or similar or expert committee; affiliated institution and 
employees, only under an appropriate understanding of confidentiality with such board or 
committee, affiliated institution and employees. Data generated by this study will be 
considered confidential by the investigator, except to the extent that it is included in a 
publication as provided in the Publications section of this protocol.
10.1.3.2
Confidentiality of Participant Records
By signing this protocol, the investigator agrees that the Sponsor (or Sponsor representative), 
IRB/IEC, or regulatory authority representatives may consult and/or copy study documents to 
verify worksheet/CRF data. By signing the consent form, the participant agrees to this 
process. If study documents will be photocopied during the process of verifying 
worksheet/CRF information, the participant will be identified by unique code only; full 
names/initials will be masked prior to transmission to the Sponsor.
By signing this protocol, the investigator agrees to treat all participant data used and 
disclosed in connection with this study in accordance with all applicable privacy laws, rules 
and regulations.
10.1.3.3
Confidentiality of IRB/IEC Information
The Sponsor is required to record the name and address of each IRB/IEC that reviews and 
approves this study. The Sponsor is also required to document that each IRB/IEC meets 
regulatory and ICH GCP requirements by requesting and maintaining records of the names 
and qualifications of the IRB/IEC members and to make these records available for 
regulatory agency review upon request by those agencies.
10.1.4
Committees Structure
10.1.4.1
Executive Oversight Committee
The Executive Oversight Committee (EOC) is composed of members of Sponsored Senior 
Management. The EOC will receive and decide on any recommendations made by the DMC 
or Steering Committee regarding the study.
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10.1.4.2
Data Monitoring Committee
To supplement the routine study monitoring outlined in the protocol, an external DMC will 
monitor the interim data from the study. The voting members of the committee are external 
to the Sponsor. The members of the DMC must not be involved with the study in any other 
way (eg, they cannot be study investigators) and must have no competing interests that could 
affect their roles with respect to the study.
The DMC will make recommendations to the EOC regarding steps to ensure both participant
safety and the continued ethical integrity of this study. Also, the DMC will review interim 
study results, consider the overall risk and benefit to study participants (Section 9.7; Interim 
Analysis) and recommend to the EOC whether the study should continue in accordance with 
the protocol.
Specific details regarding composition, responsibilities, and governance, including the roles 
and responsibilities of the various members and the Sponsor protocol team; meeting 
facilitation; the study governance structure; and requirements for and proper documentation 
of DMC reports, minutes, and recommendations will be described in the eDMC charter that 
is reviewed and approved by all the DMC members.
10.1.5
Publication Policy
The results of this study may be published or presented at scientific meetings. 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.
If publication activity is not directed by the Sponsor, 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.
Authorship will be determined by mutual agreement and in line with International Committee 
of Medical Journal Editors authorship requirements.
10.1.6
Compliance with Study Registration and Results Posting Requirements
Under the terms of the Food and Drug Administration Amendments Act (FDAAA) of 2007 
and the European Medicines Agency (EMA) clinical trial Directive 2001/20/EC, the Sponsor 
of the study is solely responsible for determining whether the study and its results are subject
to the requirements for submission to http://www.clinicaltrials.gov, 
www.clinicaltrialsregister.eu or other local registries. MSD, as Sponsor of this study, will 
review this protocol and submit the information necessary to fulfill these requirements. MSD 
entries are not limited to FDAAA or the EMA clinical trial directive mandated trials. 
Information posted will allow participants to identify potentially appropriate studies for their 
disease conditions and pursue participation by calling a central contact number for further 
information on appropriate study locations and study site contact information.
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By signing this protocol, the investigator acknowledges that the statutory obligations under 
FDAAA, the EMA clinical trials directive, or other locally mandated registries are that of the 
Sponsor and agrees not to submit any information about this study or its results to those 
registries.
10.1.7
Compliance with Law, Audit, and Debarment
By signing this protocol, the investigator agrees to conduct the study in an efficient and 
diligent manner and in conformance with this protocol; generally accepted standards of GCP
(eg, International Council for Harmonisation of Technical Requirements for Pharmaceuticals 
for Human Use GCP: Consolidated Guideline and other generally accepted standards of 
GCP); and all applicable federal, state and local laws, rules and regulations relating to the
conduct of the clinical study.
The Code of Conduct, a collection of goals and considerations that govern the ethical and 
scientific conduct of clinical investigations sponsored by MSD, is provided in this appendix 
under the Code of Conduct for Clinical Studies.
The investigator agrees not to seek reimbursement from participants, their insurance 
providers, or from government programs for procedures included as part of the study 
reimbursed to the investigator by the Sponsor.
The investigator will promptly inform the Sponsor of any regulatory authority inspection 
conducted for this study.
The investigator agrees to provide the Sponsor with relevant information from inspection 
observations/findings to allow the Sponsor to assist in responding to any citations resulting 
from regulatory authority inspection and will provide the Sponsor with a copy of the 
proposed response for consultation before submission to the regulatory authority. 
Persons debarred from conducting or working on clinical studies by any court or regulatory 
authority will not be allowed to conduct or work on this Sponsor’s studies. The investigator 
will immediately disclose in writing to the Sponsor if any person who is involved in 
conducting the study is debarred or if any proceeding for debarment is pending or, to the best 
of the investigator’s knowledge, threatened.
10.1.8
Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the Sponsor or designee electronically (eg, laboratory data). The investigator 
or qualified designee is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF.
Detailed information regarding Data Management procedures for this protocol will be 
provided separately.
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The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.
Study documentation will be promptly and fully disclosed to the Sponsor by the investigator 
upon request and also shall be made available at the study site upon request for inspection, 
copying, review, and audit at reasonable times by representatives of the Sponsor or any 
regulatory authorities. The investigator agrees to promptly take any reasonable steps that are 
requested by the Sponsor or any regulatory authorities as a result of an audit or inspection to 
cure deficiencies in the study documentation and worksheets/CRFs.
The Sponsor or designee is responsible for the data management of this study including 
quality checking of the data.
Study monitors will perform ongoing source data review and verification to confirm that data 
entered into the CRF 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.
Records and documents, including participant's documented informed consent, pertaining to 
the conduct of this study must be retained by the investigator for 15 years after study 
completion unless local regulations or institutional policies require a longer retention period. 
No records may be destroyed during the retention period without the written approval of the 
Sponsor. No records may be transferred to another location or party without written 
notification to the Sponsor.
10.1.9
Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. The investigator/institution should maintain adequate and 
accurate source documents and study records that include all pertinent observations on each 
of the site’s participants. Source documents and 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 documents are filed at the investigator’s site.
Data reported on the CRF or 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/institution may need to request previous medical records or transfer records, 
depending on the study. Also, current medical records must be available.
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10.1.10
Study and Site Closure
The Sponsor or its designee may stop the study or study site participation in the study for 
medical, safety, regulatory, administrative, or other reasons consistent with applicable laws, 
regulations, and GCP.
In the event the Sponsor prematurely terminates a particular study site, the Sponsor will 
promptly notify that study site’s IRB/IEC.
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10.2
Appendix 2: Clinical Laboratory Tests
•
The tests detailed in Table 21 will be performed by the local laboratory.
•
All on-treatment samples will be collected prior to administration of study intervention.
•
Protocol-specific requirements for inclusion or exclusion of participants are detailed in 
Section 5.1 and Section 5.2 of the protocol.
•
Additional tests may be performed at any time during the study as determined necessary 
by the investigator or required by local regulations.
Table 21
Protocol-required Safety Laboratory Assessments
Laboratory 
Assessments
Parameters
Hematology
Chemistry
Platelet Count 
RBC Indices:
MCV
MCH
%Reticulocytes
WBC count with 
Differential:
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils
RBC Count
Hemoglobin
Hematocrit
Blood Urea Nitrogen 
(BUN) or ureaa
Potassium
Aspartate 
Aminotransferase
(AST)/ Serum 
Glutamic-Oxaloacetic 
Transaminase 
(SGOT)
Total bilirubin (and 
direct bilirubin, if 
total bilirubin is 
elevated above the 
upper limit of 
normal)
Albumin
Carbon dioxide (CO2
or bicarbonate)b
Chloride
Phosphorous
Creatinine or 
creatinine clearancec
Sodium
Alanine 
Aminotransferase
(ALT)/ Serum 
Glutamic-Pyruvic 
Transaminase 
(SGPT)
Total Protein
Glucose (nonfasting)
Calcium
Alkaline phosphatase
Lactate 
dehydrogenase
Routine Urinalysis

Specific gravity

pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte 
esterase by dipstick

Microscopic examination (if blood or protein is abnormal)
Other Screening 
Tests

Follicle-stimulating hormone and estradiol (as needed in women of nonchildbearing 
potential only).

Serum or urine β human chorionic gonadotropin (β-hCG) pregnancy test (as needed 
for WOCBP).

Serology (HIV antibody, hepatitis B surface antigen [HBsAg], and hepatitis C virus 
antibody) as required by local health authority or institutional regulations. Refer to 
Appendix 7 for country-specific information.

Coagulation factors (PT or INR, and aPTT/PTT). Additional testing to be conducted 
as clinically indicated for participants taking anticoagulation therapy.

Thyroid-stimulating hormone (TSH), free thyroxine (FT4), triiodothyronine (T3) 
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Laboratory 
Assessments
Parameters
Other Tests

Bone marrow or blood cytogenetic analysis for prolonged hematological toxicities 
(Section 6.6.2.2). This should include an aspirate for cellular morphology, 
cytogenetic analysis and flow cytometry, and a core biopsy for bone marrow 
cellularity.
Abbreviations:  aPTT=activated partial thromboplastin time; FT4=free thyroxine; HIV=human immunodeficiency virus; 
INR=international normalized ratio; MCH=mean corpuscular hemoglobin; MCV=mean corpuscular volume; 
PT=prothrombin time; PTT=partial thromboplastin time; RBC = red blood cell; T3 = triiodothyronine; TSH=thyroid-
stimulating hormone; WBC=white blood cell.
Notes:
a.
BUN is preferred; if not available, urea may be tested. 
b.
Performed only if considered the local standard of care.
c.
GFR (measured or calculated) or creatinine clearance can be used in place of creatinine.
The investigator (or medically qualified designee) must document their review of each 
laboratory safety report.
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10.3
Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-up, and Reporting
10.3.1
Definition of AE
AE definition
•
An AE is any untoward medical occurrence in a clinical study participant, temporally 
associated with the use of study intervention, whether or not considered related to the 
study intervention.
•
NOTE: 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 a study intervention.
•
NOTE: For purposes of AE definition, study intervention (also referred to as Sponsor’s 
product) includes any pharmaceutical product, biological product, vaccine, diagnostic 
agent, or protocol-specified procedure whether investigational or marketed (including 
placebo, active comparator product, or run-in intervention), manufactured by, licensed 
by, provided by, or distributed by the Sponsor for human use in this study.
Events meeting the AE definition
•
Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the medical 
and scientific judgment of the investigator.
•
Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition.
•
New conditions detected or diagnosed after study intervention administration even 
though it may have been present before the start of the study.
•
Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.
•
Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication.
•
For all reports of overdose (whether accidental or intentional) with an associated AE, the 
AE term should reflect the clinical symptoms or abnormal test result. An overdose 
without any associated clinical symptoms or abnormal laboratory results is reported using 
the terminology “accidental or intentional overdose without adverse effect.”
Events NOT meeting the AE definition
•
Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that leads to 
the procedure is the AE.
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•
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.
•
Surgery planned prior to informed consent to treat a pre-existing condition that has not 
worsened.
•
Refer to Section 8.4.6 for protocol-specific exceptions.
10.3.2
Definition of SAE
If an event is not an AE per definition above, then it cannot be an SAE even if serious 
conditions are met.
An SAE is defined as any untoward medical occurrence that, at any dose:
1. Results in death
2. Is life-threatening
•
The term “life-threatening” in the definition of “serious” refers to an event in which 
the participant was at risk of death at the time of the event. It does not refer to an 
event, which hypothetically might have caused death, if it were more severe.
3. Requires inpatient hospitalization or prolongation of existing hospitalization
•
Hospitalization is defined as an inpatient admission, regardless of length of stay, even 
if the hospitalization is a precautionary measure for continued observation. (Note: 
Hospitalization for an elective procedure to treat a pre-existing condition that has not 
worsened is not an SAE. A pre-existing condition is a clinical condition that is 
diagnosed prior to the use of an MSD product and is documented in the participant’s 
medical history.
4. 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.
5. Is a congenital anomaly/birth defect
•
In offspring of participant taking the product regardless of time to diagnosis.
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6. Other important medical events
•
Medical or scientific judgment should be exercised in deciding whether SAE 
reporting is appropriate in other situations such as important medical events that may 
not be immediately life-threatening or result in death or hospitalization but may 
jeopardize the participant or may require medical or surgical intervention to prevent 1 
of the other outcomes listed in the above definition. These events should usually be 
considered serious.
Examples of such events include invasive or malignant cancers, intensive treatment in 
an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug dependency 
or drug abuse.
10.3.3
Additional Events Reported in the Same Manner as SAE
Additional events that require reporting in the same manner as SAE
In addition to the above criteria, AEs meeting either of the below criteria, although not 
serious per ICH definition, are reportable to the Sponsor in the same time frame as SAEs to 
meet certain local requirements. Therefore, these events are considered serious by the 
Sponsor for collection purposes.
•
Is a new cancer (that is not a condition of the study)
•
Is associated with an overdose
10.3.4
Recording AE and SAE
AE and SAE recording
•
When an AE/SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory, and diagnostics reports) related to 
the event.
•
The investigator will record all relevant AE/SAE information on the AE 
CRFs/worksheets at each examination.
•
It is not acceptable for the investigator to send photocopies of the participant’s medical 
records to the Sponsor in lieu of completion of the AE CRF page.
•
There may be instances when copies of medical records for certain cases are requested by 
the Sponsor. In this case, all participant identifiers, with the exception of the participant 
number, will be blinded on the copies of the medical records before submission to the 
Sponsor.
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•
The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. In such cases, the diagnosis (not the 
individual signs/symptoms) will be documented as the AE/SAE.
Assessment of intensity/toxicity
•
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, not when it is rated as severe.
•
The investigator will make an assessment of intensity for each AE and SAE (and other 
reportable safety event) according to the NCI CTCAE, version 4.0. Any AE that changes 
CTCAE grade over the course of a given episode will have each change of grade 
recorded on the AE CRFs//worksheets.
•
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated
•
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-
appropriate instrumental activities of daily living (ADL)
•
Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL
•
Grade 4: Life-threatening consequences; urgent intervention indicated
•
Grade 5: Death related to AE
Assessment of causality
•
Did the Sponsor’s product cause the AE?
•
The determination of the likelihood that the Sponsor’s product caused the AE will be 
provided by an investigator who is a qualified physician. The investigator’s signed/dated 
initials on the source document or worksheet that supports the causality noted on the AE 
form, ensures that a medically qualified assessment of causality was done. This initialed 
document must be retained for the required regulatory time frame. The criteria below are 
intended as reference guidelines to assist the investigator in assessing the likelihood of a 
relationship between the test product and the AE based upon the available information.
The following components are to be used to assess the relationship between the Sponsor’s 
product and the AE; the greater the correlation with the components and their respective 
elements (in number and/or intensity), the more likely the Sponsor’s product caused the AE:
•
Exposure: Is there evidence that the participant was actually exposed to the 
Sponsor’s product, such as: reliable history, acceptable compliance assessment (pill 
count, diary, etc.), expected pharmacologic effect, or measurement of drug/metabolite 
in bodily specimen?
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•
Time Course: Did the AE follow in a reasonable temporal sequence from 
administration of the Sponsor’s product? Is the time of onset of the AE compatible 
with a drug-induced effect (applies to studies with investigational medicinal product)?
•
Likely Cause: Is the AE not reasonably explained by another etiology, such as 
underlying disease, other drug(s)/vaccine(s), or other host or environmental factors.
•
Dechallenge: Was the Sponsor’s product discontinued or dose/exposure/frequency 
reduced?
•
If yes, did the AE resolve or improve?
•
If yes, this is a positive dechallenge.
•
If no, this is a negative dechallenge.
•
(Note: This criterion is not applicable if: (1) the AE resulted in death or 
permanent disability; (2) the AE resolved/improved, despite continuation of the 
Sponsor’s product; (3) the study is a single-dose drug study; or (4) Sponsor’s 
product(s) is/are only used 1 time.)
•
Rechallenge: Was the participant re-exposed to the Sponsor’s product in this study?
•
If yes, did the AE recur or worsen?
•
If yes, this is a positive rechallenge.
•
If no, this is a negative rechallenge.
(Note: This criterion is not applicable if: (1) the initial AE resulted in death or permanent 
disability, (2) the study is a single-dose drug study), or (3) Sponsor’s product(s) is/are used 
only 1 time.)
NOTE: IF A RECHALLENGE IS PLANNED FOR AN AE THAT WAS SERIOUS AND 
MAY HAVE BEEN CAUSED BY THE SPONSOR’S PRODUCT, OR IF RE-EXPOSURE 
TO THE SPONSOR’S PRODUCT POSES ADDITIONAL POTENTIAL SIGNIFICANT 
RISK TO THE PARTICIPANT THEN THE RECHALLENGE MUST BE APPROVED IN 
ADVANCE BY THE SPONSOR CLINICAL DIRECTOR AS PER DOSE 
MODIFICATION GUIDELINES IN THE PROTOCOL, AND IF REQUIRED, THE 
IRB/IEC.
•
Consistency with study intervention profile: Is the clinical/pathological presentation 
of the AE consistent with previous knowledge regarding the Sponsor’s product or drug 
class pharmacology or toxicology?
•
The assessment of relationship will be reported on the case report forms/worksheets by 
an investigator who is a qualified physician according to his/her best clinical judgment, 
including consideration of the above elements.
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•
Use the following scale of criteria as guidance (not all criteria must be present to be 
indicative of a Sponsor’s product relationship).
•
Yes, there is a reasonable possibility of Sponsor’s product relationship:
•
There is evidence of exposure to the Sponsor’s product. The temporal sequence of the 
AE onset relative to the administration of the Sponsor’s product is reasonable. The 
AE is more likely explained by the Sponsor’s product than by another cause.
•
No, there is not a reasonable possibility of Sponsor's product relationship:
•
Participant did not receive the Sponsor’s product OR temporal sequence of the AE 
onset relative to administration of the Sponsor’s product is not reasonable OR the AE 
is more likely explained by another cause than the Sponsor’s product. (Also entered 
for a participant with overdose without an associated AE.)
•
For each AE/SAE, the investigator must document in the medical notes that he/she has 
reviewed the AE/SAE and has provided an assessment of causality.
•
There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important 
that the investigator always make an assessment of causality for every event before the 
initial transmission of the SAE data to the Sponsor.
•
The investigator may change his/her opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality assessment.
•
The causality assessment is 1 of the criteria used when determining regulatory reporting 
requirements.
•
For studies in which multiple agents are administered as part of a combination regimen, 
the investigator may attribute each AE causality to the combination regimen or to a 
single agent of the combination. In general, causality attribution should be assigned to 
the combination regimen (ie, to all agents in the regimen). However, causality 
attribution may be assigned to a single agent if in the investigator’s opinion, there is 
sufficient data to support full attribution of the AE to the single agent.
Follow-up of AE and SAE
•
The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by 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.
•
New or updated information will be recorded in the CRF.
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•
The investigator will submit any updated SAE data to the Sponsor within 24 hours of 
receipt of the information.
10.3.5
Reporting of AEs, SAEs, and Other Reportable Safety Events to the Sponsor
AE, SAE, and other reportable safety event reporting to Sponsor via electronic data 
collection tool
•
The primary mechanism for reporting to the Sponsor will be the electronic data collection 
(EDC) tool.
•
Electronic reporting procedures can be found in the EDC data entry guidelines (or 
equivalent).
•
If the electronic system is unavailable for more than 24 hours, then the site will use 
the paper AE Reporting form.
•
Reference Section 8.4.1 for reporting time requirements.
•
The site will enter the SAE data into the electronic system as soon as it becomes 
available.
•
After the study is completed at a given site, the EDC tool will be taken off-line to prevent 
the entry of new data or changes to existing data.
•
If a site receives a report of a new SAE from a study participant or receives updated data 
on a previously reported SAE after the EDC tool has been taken off-line, then the site can 
report this information on a paper SAE form or by telephone (see next section).
•
Contacts for SAE reporting can be found in the Investigator Study File Binder (or 
equivalent).
SAE reporting to the Sponsor via paper CRF
•
If the EDC tool is not operational, facsimile transmission or secure email of the SAE 
paper CRF is the preferred method to transmit this information to the Sponsor.
•
In rare circumstances and in the absence of facsimile equipment, notification by 
telephone is acceptable with a copy of the SAE data collection tool sent by overnight 
mail or courier service.
•
Initial notification via telephone does not replace the need for the investigator to 
complete and sign the SAE CRF pages within the designated reporting time frames.
•
Contacts and instructions for SAE reporting and paper reporting procedures can be found 
in the Investigator Study File Binder (or equivalent).
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10.4
Appendix 4: Device Events, Adverse Device Events, and Medical Device 
Incidents: Definitions, Collection, and Documentation
Not applicable.
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10.5
Appendix 5: Contraceptive Guidance and Pregnancy Testing
10.5.1
Definitions
Women of Childbearing Potential (WOCBP)
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below):
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before first dose of study intervention, additional evaluation should be 
considered.
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
For individuals with permanent infertility due to an alternate medical cause other than the 
above (eg, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
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 follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormone replacement therapy (HRT). However, in the absence 
of 12 months of amenorrhea, confirmation with 2 FSH measurements in the 
postmenopausal range is required.
-
Females on HRT and whose menopausal status is in doubt will be required to use one 
of the non-hormonal 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.
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10.5.2
Contraception Requirements
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 in Section 5.1:
•
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.
•
Use a male condom plus partner use of an additional contraceptive method when 
having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
-
The following are not acceptable methods of contraception:
•
Periodic abstinence (calendar, symptothermal, post-ovulation methods), 
withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea 
method (LAM).
•
Male condom with cap, diaphragm, or sponge with spermicide.
•
Male and female condom cannot be 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. 
-
Note: Male participants must refrain from donating sperm during treatment and for at 
least 180 days after the last dose of study intervention.
Female Participants
Female participants of childbearing potential are eligible to participate if they agree to 
consistent and correct use of a highly effective method of contraception as described in 
Table 22 during the protocol-defined time frame in Section 5.1.
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Table 22
Highly Effective Contraception Methods
Contraceptives allowed during the study includea:
Highly Effective Contraceptive Methods That Have Low User Dependency
Failure rate of <1% per year when used consistently and correctly.
•
Progestogen-only subdermal contraceptive implantb
•
IUSc
•
Non-hormonal IUD
•
Bilateral tubal occlusion
•
Azoospermic partner (vasectomized or secondary to medical cause)
This is a highly effective contraception method provided that the partner is the sole male sexual partner of the 
WOCBP and the absence of sperm has been confirmed. If not, an additional highly effective method of 
contraception should be used. A spermatogenesis cycle is approximately 90 days.
Note: Documentation of azoospermia for a male participant can come from the site personnel’s review of the 
participant’s medical records, medical examination, or medical history interview.
Sexual Abstinence
•
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of 
the participant.
a
Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for participants of clinical studies.
b
If locally required, in accordance with CTFG guidelines, acceptable contraceptive implants are limited to those 
which inhibit ovulation.
c
IUS is a progestin releasing IUD.
Note: The following are not acceptable methods of contraception:
- Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), 
spermicides only, and LAM.
- Male condom with cap, diaphragm, or sponge with spermicide.
- Male and female condom should not be used together (due to risk of failure with friction).
10.5.3
Pregnancy Testing
•
Pregnancy testing requirements for study inclusion are described in Section 5.1.
•
Pregnancy testing (urine or serum as required by local regulations) should be conducted 
as indicated in the SoA.
•
Pregnancy testing (urine or serum as required by local regulations) should be conducted 
for the time required to eliminate systemic exposure after the last dose of each study 
interventions as noted in Section 5.1. The length of time required to continue pregnancy 
testing for each study intervention is 180 days following the last dose of pembrolizumab, 
olaparib, or cytotoxic chemotherapy.
•
Additional serum or urine pregnancy tests may be performed, as determined necessary by 
the investigator or required by local regulation, to establish the absence of pregnancy at 
any time during the participant's participation in the study.
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CCI
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CCI
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CCI
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CCI
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CCI
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10.7
Appendix 7: Country-specific Requirements
10.7.1
France-specific Requirements

Section 1.3.1 Schedule of Activities for Screening and Induction Phases
Pregnancy testing must be performed at each cycle during treatment as well as at the 
end of study treatment.

Section 1.3.2 Schedule of Activities for Maintenance Phase
Pregnancy testing must be performed at each cycle during treatment as well as at the 
end of study treatment.

Section 1.3.4 Schedule of Activities for Second Course Retreatment Phase
Pregnancy testing must be performed at each cycle during treatment as well as at the 
end of study treatment.

Section 10.5 Appendix 5: Contraceptive Guidance and Pregnancy Testing
Pregnancy testing must be performed at each cycle during treatment as well as at the 
end of study treatment.
10.7.2
Germany-specific Requirements

Exclusion Criterion 10: HIV testing is mandatory.

Exclusion Criterion 11: hepatitis B and C testing is mandatory.

Section 1.3.1 Schedule of Activities for Screening and Induction Phases
Monthly urine pregnancy testing is required during treatment as well as at the end of 
study treatment.

Section 1.3.2 Schedule of Activities for Maintenance Phase
Monthly urine pregnancy testing is required during treatment as well as at the end of 
study treatment.

Section 1.3.4 Schedule of Activities for Second Course Retreatment Phase
Monthly urine pregnancy testing is required during treatment as well as at the end of 
study treatment.

Section 6.5.1 (Prohibited Concomitant Medications):
Live vaccines must not be administered for 90 days after the last dose of study 
intervention.
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
Legally Acceptable Representative protocol sections 
In order for a participant to be eligible to participate in Germany, they must be 
capable of providing documented informed consent; therefore, all references to a 
participant’s “legally acceptable representative” in the protocol are not applicable 
for participants in Germany.

Section 10.5 Appendix 5: Contraceptive Guidance and Pregnancy Testing
Monthly urine pregnancy testing after randomization is required during treatment as 
well as at the end of study treatment.
10.7.3
Japan-specific Requirements

For the assistance to early diagnosis of pneumonitis/ILD in study participants, the 
following items such as pulse oximetry monitoring (SpO2), CRP, KL-6, and SP-D 
will be measured in this study. These items should be measured according to the 
following timing.
o
SpO2: at the timing of vital sign assessment.
o
CRP, KL-6 and SP-D: at screening*, pre-dose of Day 1 of every cycle, end-
of-treatment, and safety follow-up visit (30 days after last dose).
* should be measured at the timing of clinical laboratory tests (such as 
hematology/ chemistry).

In the case that pneumonitis/ILD occurs regardless of causality with study 
medication, an independent ILD evaluation committee will conduct adjudication of 
cases of the pneumonitis/ILD. For this purpose, relevant data such as chest imaging 
(from the baseline to the recovery of pneumonitis/ILD) will be submitted to MSD 
K.K.
10.7.4
United Kingdom-specific Requirements

Section 6.5.1 (Prohibited Concomitant Medications): Live vaccines must not be 
administered for 90 days after the last dose of study intervention. Refer to 
Section 6.5 for information on COVID-19 vaccines.

Males are to be advised to seek counseling on sperm storage before starting 
pemetrexed and platinum-based therapy as per respective SmPCs.

Section 1.3.1: Schedule of Activities for Screening and Induction Phases
Monthly urine pregnancy testing is required during treatment as well as at the end 
of study treatment.
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
Section 1.3.2: Schedule of Activities for Maintenance Phase
Monthly urine pregnancy testing is required during treatment as well as at the end 
of study treatment.

Section 1.3.4 Schedule of Activities – Second Course Treatment Phase  
Monthly urine pregnancy testing is required during treatment as well as at the end 
of study treatment.

Section 10.5 Appendix 5: Contraceptive Guidance and Pregnancy Testing
Monthly urine pregnancy testing is required during treatment as well as at the end 
of study treatment.
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10.8
Appendix 8: Description of the iRECIST Process for Assessment of Disease 
Progression
iRECIST is based on RECIST 1.1 but adapted to account for the unique tumor response seen 
with immunotherapeutic drugs. iRECIST will be used by the investigator to assess tumor 
response and progression, and to guide decisions about changes in management.
Assessment at Screening and Before RECIST 1.1 Progression
Until radiographic disease progression based on RECIST 1.1, there is no distinct iRECIST 
assessment.
Assessment and Decision at RECIST 1.1 Progression
For participants who show radiological PD by RECIST 1.1, the investigator will decide 
whether to continue a participant on study intervention until repeat scans 4 to 8 weeks later
obtained as described in Section 8.2.1.6.
Tumor flare may manifest as any factor causing radiographic progression per RECIST 1.1, 
including:
•
Increase in the sum of diameters of target lesion(s) identified at baseline to ≥20% and 
≥5 mm from nadir
Note: The iRECIST publication uses the terminology “sum of measurements,” but “sum 
of diameters” will be used in this protocol, consistent with the original RECIST 1.1 
terminology.
•
Unequivocal progression of nontarget lesion(s) identified at baseline
•
Development of new lesion(s)
iRECIST defines new response categories, including iUPD (unconfirmed progressive 
disease) and iCPD (confirmed progressive disease). For purposes of iRECIST assessment, 
the first visit showing progression according to RECIST 1.1 will be assigned a visit (overall) 
response of iUPD, regardless of which factors caused the progression.
At this visit, target and nontarget lesions identified at baseline by RECIST 1.1 will be 
assessed as usual.
New lesions will be classified as measurable or nonmeasurable, using the same size 
thresholds and rules as for baseline lesion assessment in RECIST 1.1. From measurable new 
lesions, up to 5 lesions total (up to 2 per organ), may be selected as New Lesions – Target. 
The sum of diameters of these lesions will be calculated and kept distinct from the sum of 
diameters for target lesions at baseline. All other new lesions will be followed qualitatively 
as New Lesions – Nontarget.
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Assessment at the Confirmatory Scans
On the confirmatory scans, the participant will be classified as progression confirmed (with 
an overall response of iCPD), or as showing persistent unconfirmed progression (with an 
overall response of iUPD), or as showing disease stability or response (iSD/iPR/iCR).
Confirmation of Progression
Progression is considered confirmed, and the overall response will be iCPD, if ANY of the 
following occurs:
•
Any of the factors that were the basis for the iUPD at the previous visit show worsening
-
For target lesions, worsening is a further increase in the sum of diameters of ≥5 mm, 
compared to any prior iUPD time point
-
For nontarget lesions, worsening is any significant growth in lesions overall, 
compared to a prior iUPD time point; this does not have to meet the “unequivocal” 
standard of RECIST 1.1
-
For new lesions, worsening is any of these:
◦
An increase in the new lesion sum of diameters by ≥5 mm from a prior iUPD time 
point
◦
Visible growth of new nontarget lesions
◦
The appearance of additional new lesions
•
Any new factor appears that would have triggered PD by RECIST 1.1
Persistent iUPD
Progression is considered not confirmed, and the overall response remains iUPD, if:
•
None of the progression-confirming factors identified above occurs AND
•
The target lesion sum of diameters (initial target lesions) remains above the initial PD 
threshold (by RECIST 1.1)
Additional scans for confirmation are to be scheduled 4 to 8 weeks from the scans on which 
iUPD is seen. This may correspond to the next visit in the original visit schedule. The 
assessment of the subsequent confirmation scan proceeds in an identical manner, with 
possible outcomes of iCPD, iUPD, and iSD/iPR/iCR.
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Resolution of iUPD
Progression is considered not confirmed, and the overall response becomes iSD/iPR/iCR, if:
•
None of the progression-confirming factors identified above occurs, AND
•
The target lesion sum of diameters (initial target lesions) is not above the disease 
progression threshold.
The response is classified as iSD or iPR (depending on the sum of diameters of the target 
lesions), or iCR if all lesions resolve.
In this case, the initial iUPD is considered to be pseudo-progression, and the level of 
suspicion for progression is “reset.” This means that the next visit that shows radiographic 
progression, whenever it occurs, is again classified as iUPD by iRECIST, and the 
confirmation process is repeated before a response of iCPD can be assigned.
Management Following the Confirmatory Scan
If repeat scans do not confirm disease progression, and the participant continues to be 
clinically stable, study intervention is to continue. The regular scan schedule is to be 
followed. If disease progression is confirmed, participants may be discontinued from study 
intervention.
NOTE: If a participant has confirmed radiographic progression (iCPD) and clinically 
meaningful benefit, study intervention may be continued, after consultation with the Sponsor. 
If study intervention is continued, tumor scans are to be performed after the intervals as 
outlined in Section 1.3.
Detection of Progression at Visits After Pseudo-progression Resolves
After resolution of pseudo-progression (ie, after iSD/iPR/iCR), another instance of 
progression (another iUPD) is indicated by any of the following events:
•
Target lesions
-
Sum of diameters reaches the PD threshold (≥20% and ≥5 mm increase from nadir) 
either for the first time, or after resolution of previous pseudo-progression. The nadir 
is always the smallest sum of diameters seen during the entire study, either before or 
after an instance of pseudo-progression.
•
Nontarget lesions
-
If nontarget lesions have never shown unequivocal progression, their doing so for the 
first-time results in iUPD.
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-
If nontarget lesions have shown previous unequivocal progression, and this 
progression has not resolved, iUPD results from any significant further growth of 
nontarget lesions, taken as a whole.
•
New lesions
-
New lesions appear for the first time
-
Additional new lesions appear
-
Previously identified new target lesions show an increase of ≥5 mm in the new lesion 
sum of diameters, from the nadir value of that sum
-
Previously identified nontarget lesions show any significant growth
If any of the events above occur, the overall response for that visit is iUPD, and the iUPD 
evaluation process (see Assessment at the Confirmatory Scan above) is repeated. Progression 
must be confirmed before iCPD can occur.
The decision process on the subsequent iUPD is identical to the iUPD confirmation process 
for the initial disease progression, with one exception, which can occur if new lesions had 
occurred at a prior instance of iUPD, had not resolved, then worsened (increase in size or 
number) leading to the second iUPD. If the new lesion worsening has not resolved at the 
confirmatory scan then iUPD cannot resolve to iSD or iPR. It will remain iUPD until either a 
decrease in the new lesion burden allows resolution to iSD or iPR, or until new or worsening
cause of progression indicates iCPD.
Additional details about iRECIST are provided in the iRECIST publication [Seymour, L., et 
al 2017].
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10.9
Appendix 9: Abbreviations
Abbreviation
Expanded Term
1L
first-line
AE
adverse event 
AEOSI
adverse events of special interest
ALK
anaplastic lymphoma kinase 
ALT 
alanine aminotransferase
AML
acute myeloid leukemia 
APaT
all participants as treated
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
ATM
ataxia-telangiectasia mutated 
AUC
area under concentration-time curve
β-HCG
β-human chorionic gonadotropin
BICR
blinded independent central review 
BID
twice daily
CNS
central nervous system 
CONSORT
Consolidated Standards of Reporting Trials 
COVID
corona virus disease
CR
complete response
CrCl
creatinine clearance
CRF
Case Report Form 
CRU
clinical research unit
CT
computed tomography
CTCAE
Common Terminology Criteria for Adverse Events
CTFG
Clinical Trial Facilitation Group 
DBP
diastolic blood pressure
DC
discontinuation
DILI
drug-induced liver injury
DL
dose level
DMC
Data Monitoring Committee 
DNA
deoxyribonucleic acid 
DOR
duration of response 
DSB
double strand breaks 
ECG
electrocardiogram 
ECI
event of clinical interest
ECOG
Eastern Cooperative Cancer Group
eCRF
electronic Case Report Form
EDC
electronic data collection 
eDMC
external data monitoring committee
EGFR
epidermal growth factor receptor 
EMA
European Medicines Agency
EOC
Executive Oversight Committee 
EOT
end of therapy
FAS
full analysis set
FBR
Future Biomedical Research
FDA
Food and Drug Administration
FDAAA
Food and Drug Administration Amendments Act
FSH
Follicle-stimulating hormone 
CCI
CCI
CCI
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Abbreviation
Expanded Term
FT4
free thyroxine
GCP
Good Clinical Practice 
G-CSF
granulocyte colony-stimulating factor 
GFR
glomerular filtration rate
GM CSF
granulocyte-macrophage colony-stimulating factor 
GMP
Good Manufacturing Practice
HA
health authority
Hb
hemoglobin
HBV
hepatitis B virus
HCV
hepatitis C virus
HDPE
high-density polyethylene 
HIV
human immunodeficiency virus
HR
heart rate; hazard ratio
HRD
homologous recombination deficiency
HRD-LOH
homologous recombination deficiency loss of heterozygosity
HRQoL
health-related quality of life 
HRRm
homologous recombination repair
HRT
hormone replacement therapy
IB
Investigator’s Brochure 
ICF
Informed Consent Form 
ICH
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use
iCPD
iRECIST confirmed progressive disease
iCR
iRECIST complete response
iCRO
imaging contract research organization
ID
identification
IEC
Independent Ethics Committee
IgG4
immunoglobulin G4 
IHC
immunohistochemistry
ILD
interstitial lung disease
IMP
Investigational Medicinal Product
IND
Investigational New Drug 
INR
International Normalized Ratio
irAEs
immune-related AEs 
IRB
Institutional Review Board 
iRECIST
modified Response Evaluation Criteria in Solid Tumors 1.1 for immune-based 
therapeutics
IRT
interactive response system
iSD
iRECIST stable disease
IUD
intrauterine device
iUPD
iRECIST unconfirmed progressive disease
IUS
intrauterine hormone-releasing system
IV
intravenous 
LOH
loss of heterozygosity 
MATE
multidrug and toxic compound extrusion 
MDS
myelodysplastic syndrome 
MRI
magnetic resonance imaging 
mRNA
messenger RNA
MSI
microsatellite instability
MTD
maximum tolerated dose 
Nab-paclitaxel
nano particle albumin-bound paclitaxel
NCI CTCAE
National Cancer Institute Common Terminology Criteria for Adverse Events 
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Abbreviation
Expanded Term
NDA
New Drug Application 
NHEJ
non-homologous end-joining
NIMP
Non-investigational Medicinal Product
NOAEL
no observed adverse effect level 
NSCLC
non-small cell lung cancer
OATP
organic-anion-transporting polypeptide 
OCT
organic cation transporter 
ORR
objective response rate 
OS
overall survival
OTC
over-the-counter 
PARP
polyadenosine 5′ diphosphoribose (polyADP ribose) polymerization
PBPK
physiologically based PK
PD
progressive disease
PD-1
programmed cell death 1 
PD-L1
programmed cell death ligand 1 
PD-L2
programmed cell death ligand 2
PET
positron emission tomography 
PFS
progression-free survival
PK
pharmacokinetic
PR
partial response
PT
prothrombin time
Q3W
every 3 weeks
Q8W
every 8 weeks
Q12W
every 12 weeks
QoL
quality of life 
RECIST
Response Evaluation Criteria in Solid Tumors
RMST
Restricted Mean Survival Time
RNA
ribonucleic acid
RR
respiratory rate
SAC
Scientific Advisory Committee
SAE
serious adverse event 
SAP
SBP
systolic blood pressure
SD
stable disease
SGOT
serum glutamic-oxaloacetic aminotransferase
SGPT
serum glutamic-pyruvic aminotransferase
SIM
Site Imaging Manual 
SoA
schedule of activities
SOC
standard of care
sSAP
SSB
single strand break
SUSAR
suspected unexpected serious adverse reaction
T3
triiodothyronine
TFST
time to first subsequent anticancer therapy
TMB
tumor mutation burden;
TMDD
target-mediated drug disposition 
TPS
tumor proportion score
TSH
Thyroid-stimulating hormone
TSST
time to second subsequent anticancer therapy
UDS
urine drug screen
ULN
upper limit of normal
CCI
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Abbreviation
Expanded Term
US
United States
VOP
verification of progression
WOCBP
woman/women of childbearing potential 
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11
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