Efficacy and Safety of Pembrolizumab Plus Investigational... | NCT04924101

ID	Type	Description
MK-3475-B99	Other Identifier	MSD
KEYNOTE-B99	Other Identifier	MSD
2023-506538-56-00	Registry Identifier	EU CT
U1111-1293-9965	Registry Identifier	UTN
2023-506538-56	EudraCT Number

Label	Type	Description	Intervention Names
Pembrolizumab + MK-4830 + Chemotherapy	Experimental	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.	Biological: Pembrolizumab Biological: MK-4830 Drug: Etoposide Drug: Cisplatin Drug: Carboplatin
Pembrolizumab + Boserolimab + Chemotherapy	Experimental	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.	Biological: Pembrolizumab Biological: Boserolimab Drug: Etoposide Drug: Cisplatin Drug: Carboplatin
Pembrolizumab + Lenvatinib + Chemotherapy	Experimental	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Name	Type	Description	Arm Group Labels	Other Names
Pembrolizumab	Biological	IV infusion	Pembrolizumab + Boserolimab + Chemotherapy Pembrolizumab + Lenvatinib + Chemotherapy Pembrolizumab + MK-4830 + Chemotherapy

Measure	Description	Time Frame
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.	Up to approximately 43 months
Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1	Six-month PFS rate is defined as the percentage of participants who have survival without documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS rate at 6 months as assessed by BICR is presented.	At 6 months

Measure	Description	Time Frame
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1	For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (7 days); Etoposide, Cisplatin, or Carboplatin (180 days) and Pembrolizumab, MK-4830, or (no contraception measures); refrain from donating sperm plus either 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 must agree to use contraception per protocol unless confirmed to be azoospermic
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman/women of childbearing potential (WOCBP) or is a WOCBP and uses a contraceptive method that is highly effective with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (30 days), Etoposide, Cisplatin, or Carboplatin (180 days), and Pembrolizumab, MK-4830, or Boserolimab (120 days)
A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention
Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by blinded independent central review (BICR)
Submits an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated where such sample exist
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
Has adequate organ function within 10 days before the first dose of study intervention
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no changes in antihypertensive medications within 1 week before randomization

Exclusion Criteria:

Has had major surgery within 3 weeks before first dose of study interventions
Has a preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
Has urine protein ≥1 g/24 hours
Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
Prolongation of QT interval with Fridericia's correction (QTcF) interval to >480 ms
Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
Has active hemoptysis within 3 weeks before the first dose of study intervention
Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption
Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention
Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the first dose of study intervention must be on stable doses of anticoagulants
Has a history of inflammatory bowel disease
Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention
Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease
Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior treatment (chemotherapy, radiotherapy, or surgical resection) including investigational agents for SCLC
Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. A participant that meets this exclusion criterion but is otherwise deemed eligible for the study may be randomized across the specific intervention groups.
Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions is eligible
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
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following: a) Completed treatment at least 14 days before the first dose of study intervention b) Have no evidence of new or enlarging brain metastases confirmed by posttreatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and c) Are neurologically stable without the need for steroids for at least 7 days before the first dose of study intervention as per local site assessment. Participants with untreated brain metastases will be allowed if they are asymptomatic, the investigator determines there is no immediate CNS-specific treatment required, there is no significant surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer in number
Has a history of severe hypersensitivity reaction to any study intervention and/or any of its excipients
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has a known history of, or active, neurologic paraneoplastic syndrome
Has an active infection requiring systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B virus infection or an active Hepatitis C infection
Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has had an allogenic tissue/solid organ transplant

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Banner MD Anderson Cancer Center ( Site 0102)		Gilbert	Arizona	85234	United States
University of Colorado Anschutz Medical Campus ( Site 0104)

Label	URL
Merck Clinical Trials Information	View source
Plain Language Summary	View source

ID	Title	Description
FG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Dec 21, 2022

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.

The analysis population included all participants who received at least one dose of study intervention.

Posted

Number

95% Confidence Interval

Percentage of participants

Up to approximately 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG002	Pembrolizumab + Lenvatinib + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Units	Counts
Participants	OG00043 OG00141 OG00238

Title

Denominators

Categories

Title	Measurements
	OG00065.1(49.1 to 79.0) OG00173.2(57.1 to 85.8) OG00273.7(56.9 to 86.6)

Primary

Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1

Six-month PFS rate is defined as the percentage of participants who have survival without documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS rate at 6 months as assessed by BICR is presented.

The analysis population included all participants who received at least one dose of study intervention.

Posted

Number

95% Confidence Interval

Percentage of Participants

At 6 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001

Secondary

Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1

For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.

The analysis population included all participants who received at least one dose of study intervention and who achieved CR or PR.

Posted

Median

95% Confidence Interval

Months

Up to approximately 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Secondary

Progression-Free Survival (PFS) as Assessed by BICR Per RECIST 1.1

PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.

The analysis population included all participants who received at least one dose of study intervention.

Posted

Median

95% Confidence Interval

Months

Up to approximately 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy

Secondary

Overall Survival (OS)

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented.

The analysis population included all participants who received at least one dose of study intervention.

Posted

Median

95% Confidence Interval

Months

Up to approximately 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Secondary

Mean Percent Change From Baseline in Tumor Size as Assessed by BICR Per RECIST 1.1

Tumor size change is defined as the percent change from baseline in the sum of the diameters of the target lesions as assessed by BICR per RECIST 1.1. Mean percent change from baseline in tumor size as assessed by BICR per RECIST 1.1 is presented.

The analysis population included all participants who received at least one dose of study intervention with at least one post-baseline target lesion.

Posted

Mean

Standard Deviation

Percent change

Baseline and up to 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Secondary

Number of Participants Who Experienced an Adverse Event (AE)

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. 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. The number of participants who experience an AE is presented.

The analysis population included all participants who received at least one dose of study intervention.

Posted

Count of Participants

Participants

Up to approximately 43 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy

Secondary

Number of Participants Who Discontinued Study Treatment Due to an AE

The analysis population included all participants who received at least one dose of study intervention.

Posted

Count of Participants

Participants

Up to approximately 22 months

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
OG001	Pembrolizumab + Boserolimab + Chemotherapy

Secondary

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.

The analysis population included all randomized participants who received at least one dose of study intervention and who had patient reported outcome (PRO) assessments available at both baseline and the specified post baseline for the specific endpoint.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline, Week 19

ID	Title	Description
OG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Aplastic anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0023 events3 affected38 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events2 affected41 at risk EG0022 events2 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Atrial flutter	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Cardiac arrest	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0012 events1 affected41 at risk EG0020 events0 affected38 at risk
Colitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Immune-mediated pancreatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Death	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Impaired healing	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events1 affected38 at risk
Immune-mediated cholangitis	Hepatobiliary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Anorectal infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Candida infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Device related infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Oral herpes	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Pneumonia	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected43 at risk EG0013 events3 affected41 at risk EG0025 events5 affected38 at risk
Pneumonia aspiration	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Sepsis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected41 at risk EG0023 events3 affected38 at risk
Septic shock	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Wound infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0021 events1 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Encephalitis autoimmune	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Hypoglossal nerve disorder	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Spinal cord compression	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0021 events1 affected38 at risk
Renal tubular disorder	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Aneurysm ruptured	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0021 events1 affected38 at risk
Femoral artery perforation	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00034 events26 affected43 at risk EG00129 events23 affected41 at risk EG00245 events25 affected38 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00018 events14 affected43 at risk EG00124 events14 affected41 at risk EG00215 events7 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00051 events30 affected43 at risk EG00147 events29 affected41 at risk EG00270 events30 affected38 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 28.0	Systematic Assessment	EG00017 events10 affected43 at risk EG00124 events15 affected41 at risk EG00250 events21 affected38 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG0007 events5 affected43 at risk EG0016 events6 affected41 at risk EG0024 events4 affected38 at risk
Hypothyroidism	Endocrine disorders	MedDRA 28.0	Systematic Assessment	EG00011 events8 affected43 at risk EG0018 events8 affected41 at risk EG00218 events15 affected38 at risk
Constipation	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0009 events7 affected43 at risk EG0017 events7 affected41 at risk EG0025 events5 affected38 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00011 events8 affected43 at risk EG0013 events3 affected41 at risk EG00223 events17 affected38 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected41 at risk EG0023 events3 affected38 at risk
Gastritis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected43 at risk EG0010 events0 affected41 at risk EG0023 events3 affected38 at risk
Nausea	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG00021 events14 affected43 at risk EG00110 events6 affected41 at risk EG00215 events12 affected38 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0012 events2 affected41 at risk EG00212 events10 affected38 at risk
Vomiting	Gastrointestinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0016 events5 affected41 at risk EG0023 events3 affected38 at risk
Asthenia	General disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Fatigue	General disorders	MedDRA 28.0	Systematic Assessment	EG00014 events13 affected43 at risk EG0019 events7 affected41 at risk EG00212 events11 affected38 at risk
Non-cardiac chest pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected41 at risk EG0022 events2 affected38 at risk
Oedema peripheral	General disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected41 at risk EG0026 events6 affected38 at risk
Pain	General disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Pyrexia	General disorders	MedDRA 28.0	Systematic Assessment	EG0006 events3 affected43 at risk EG0012 events2 affected41 at risk EG0026 events2 affected38 at risk
COVID-19	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected43 at risk EG0011 events1 affected41 at risk EG0026 events6 affected38 at risk
Gingivitis	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected41 at risk EG0023 events3 affected38 at risk
Rash pustular	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Skin infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Urinary tract infection	Infections and infestations	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected43 at risk EG0012 events2 affected41 at risk EG0020 events0 affected38 at risk
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0018 events5 affected41 at risk EG0022 events2 affected38 at risk
Alanine aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected43 at risk EG00110 events6 affected41 at risk EG00211 events8 affected38 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0018 events7 affected41 at risk EG00214 events8 affected38 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0011 events1 affected41 at risk EG0025 events3 affected38 at risk
Blood bilirubin increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0018 events5 affected41 at risk EG0023 events2 affected38 at risk
Blood creatinine increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0005 events4 affected43 at risk EG0016 events5 affected41 at risk EG00211 events5 affected38 at risk
Blood thyroid stimulating hormone increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0023 events2 affected38 at risk
Lymphocyte count decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG00112 events4 affected41 at risk EG0020 events0 affected38 at risk
SARS-CoV-2 test positive	Investigations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Weight decreased	Investigations	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0013 events3 affected41 at risk EG0025 events5 affected38 at risk
Weight increased	Investigations	MedDRA 28.0	Systematic Assessment	EG0007 events6 affected43 at risk EG0010 events0 affected41 at risk EG0020 events0 affected38 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0008 events7 affected43 at risk EG0014 events4 affected41 at risk EG00211 events11 affected38 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0012 events1 affected41 at risk EG0021 events1 affected38 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events1 affected43 at risk EG0012 events1 affected41 at risk EG0026 events4 affected38 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0009 events5 affected43 at risk EG0013 events3 affected41 at risk EG0026 events4 affected38 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0009 events4 affected43 at risk EG0014 events3 affected41 at risk EG0025 events3 affected38 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected43 at risk EG0013 events3 affected41 at risk EG0027 events5 affected38 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 28.0	Systematic Assessment	EG0002 events2 affected43 at risk EG0012 events2 affected41 at risk EG0022 events2 affected38 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG00011 events7 affected43 at risk EG0015 events4 affected41 at risk EG0026 events5 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0006 events4 affected43 at risk EG0012 events2 affected41 at risk EG0023 events3 affected38 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 28.0	Systematic Assessment	EG0003 events2 affected43 at risk EG0017 events7 affected41 at risk EG0020 events0 affected38 at risk
Tumour associated fever	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Dizziness	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected43 at risk EG0011 events1 affected41 at risk EG0024 events4 affected38 at risk
Headache	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected43 at risk EG0015 events5 affected41 at risk EG0025 events5 affected38 at risk
Paraesthesia	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0004 events3 affected43 at risk EG0010 events0 affected41 at risk EG0023 events3 affected38 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Anxiety	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Delirium	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Insomnia	Psychiatric disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected43 at risk EG0012 events2 affected41 at risk EG0024 events4 affected38 at risk
Dysuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected43 at risk EG0011 events1 affected41 at risk EG0021 events1 affected38 at risk
Proteinuria	Renal and urinary disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG00235 events18 affected38 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0005 events5 affected43 at risk EG0012 events2 affected41 at risk EG0022 events2 affected38 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0006 events5 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0013 events3 affected41 at risk EG0021 events1 affected38 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0025 events5 affected38 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0003 events3 affected43 at risk EG0011 events1 affected41 at risk EG0021 events1 affected38 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 28.0	Systematic Assessment	EG0004 events4 affected43 at risk EG0011 events1 affected41 at risk EG0020 events0 affected38 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected43 at risk EG0019 events9 affected41 at risk EG0026 events6 affected38 at risk
Dermatitis acneiform	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0023 events2 affected38 at risk
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0010 events0 affected41 at risk EG0027 events5 affected38 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0008 events8 affected43 at risk EG0016 events6 affected41 at risk EG0026 events6 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0010 events0 affected41 at risk EG0022 events2 affected38 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0006 events6 affected43 at risk EG0016 events6 affected41 at risk EG0023 events3 affected38 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 28.0	Systematic Assessment	EG0000 events0 affected43 at risk EG0011 events1 affected41 at risk EG0022 events2 affected38 at risk
Hypertension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0008 events7 affected43 at risk EG0012 events2 affected41 at risk EG00222 events12 affected38 at risk
Hypotension	Vascular disorders	MedDRA 28.0	Systematic Assessment	EG0001 events1 affected43 at risk EG0011 events1 affected41 at risk EG0023 events3 affected38 at risk

ID	Term
D055752	Small Cell Lung Carcinoma
C565324	Parkinson Disease 4, Autosomal Dominant Lewy Body

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D011034	Podophyllotoxin
D013764	Tetrahydronaphthalenes
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D005960	Glucosides
D006027	Glycosides
D002241	Carbohydrates
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D056831	Coordination Complexes

ID	Title	Description
BG000	Pembrolizumab + MK-4830 + Chemotherapy	Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
BG001	Pembrolizumab + Boserolimab + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
BG002	Pembrolizumab + Lenvatinib + Chemotherapy	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	MK-4830 + Pembrolizumab + Etoposide/Platinum	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.	28	43	13	43	41	43
EG001	MK-5890 + Pembrolizumab +Etoposide/Platinum	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.	31	41	16	41	41	41
EG002	Lenvatinib +Pembrolizumab + Etoposide/Platinum	Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.	28	38	25	38	38	38

ID	Term
C582435	pembrolizumab
C531958	lenvatinib
D005047	Etoposide
C061400	etoposide phosphate
D002945	Cisplatin
D016190	Carboplatin