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← Small Cell Lung Cancer

NCT03066778 · STUDY IN CONTEXT

A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNO

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD, as determined by RECIST 1.1, was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 was also considered PD. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The PFS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.

The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.

The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.

→

secondary · POSTED

ORR was defined as the percentage of participants who achieve a best objective response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The ORR was calculated using the Miettinen \& Nurminen method stratified by type of platinum therapy (carboplatin or cisplatin), baseline ECOG performance status (0 or 1), and baseline LDH (≤ or \> upper limit of normal) and presented for the first course of study treatment per protocol.

The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.

→

secondary · POSTED

DOR was defined as the time from first documented evidence of a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 until progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurred first. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data and is presented for the first course of study treatment per protocol.

The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR.

→

secondary · POSTED

An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.

The analysis population consisted of all participants who received at least 1 dose of study treatment.

→

secondary · POSTED

An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who discontinued due to an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.

The analysis population consisted of all participants who received at least 1 dose of study treatment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Change From Baseline at Week 18 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03066778
qol key
qol-0007
source section id
NCT03066778-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline at Week 18 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. Change from baseline scores were calculated using a constrained longitudinal data analysis (cLDA) model. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Data are presented for the first course of study treatment per protocol.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 18.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline at Week 12 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03066778
qol key
qol-0008
source section id
NCT03066778-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline at Week 12 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 12. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline at Week 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03066778
qol key
qol-0009
source section id
NCT03066778-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline at Week 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
measure definition
EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
time frame
Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 24. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03066778
qol key
qol-0010
source section id
NCT03066778-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)
measure definition
TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.
time frame
Day 1 of Cycles 1-9, Day 1 of every other cycle for Cycles 10-17 and 30 days after last dose of study treatment (Up to approximately 27 months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All participants who received at least 1 dose of study medication and had non-missing assessments.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-small-cell-lung-cancer
nct id
NCT03066778
trial label
A Study of Pembrolizumab (MK-3475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for Participants With Extensive Stage Small Cell Lung Cancer (MK-3475-604/KEYNO
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0000
    source section id
    NCT03066778-om-0000
    source outcome index
    0
    endpoint
    Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD, as determined by RECIST 1.1, was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. 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 was also considered PD. For this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The PFS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 30.5 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0001
    source section id
    NCT03066778-om-0001
    source outcome index
    1
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis were censored at the date of the last follow up. The OS was calculated using the non-parametric Kaplan-Meier method for censored data and presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 30.5 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0002
    source section id
    NCT03066778-om-0002
    source outcome index
    2
    endpoint
    Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    ORR was defined as the percentage of participants who achieve a best objective response of complete response (CR) or partial response (PR) per RECIST 1.1. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The ORR was calculated using the Miettinen \& Nurminen method stratified by type of platinum therapy (carboplatin or cisplatin), baseline ECOG performance status (0 or 1), and baseline LDH (≤ or \> upper limit of normal) and presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 30.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0003
    source section id
    NCT03066778-om-0003
    source outcome index
    3
    endpoint
    Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
    endpoint definition
    DOR was defined as the time from first documented evidence of a Complete Response (CR) or Partial Response (PR) per RECIST 1.1 until progressive disease (PD) per RECIST 1.1 or death due to any cause, whichever occurred first. CR was defined as the disappearance of all target lesions. PR was defined as ≥30% decrease in the sum of diameters of target lesions taking as a reference the baseline sum diameters. PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of ≥1 new lesions was also considered PD. In this study, RECIST 1.1 was modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data and is presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 30.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all randomized participants who were included in the treatment group to which they were randomized and experienced a CR or PR.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0004
    source section id
    NCT03066778-om-0004
    source outcome index
    4
    endpoint
    Number of Participants Who Experienced an Adverse Event (AE)
    endpoint definition
    An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 30.5 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all participants who received at least 1 dose of study treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0005
    source section id
    NCT03066778-om-0005
    source outcome index
    5
    endpoint
    Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
    endpoint definition
    An adverse event was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an adverse event. The number of participants who discontinued due to an AE was reported for each arm according to the treatment received and is presented for the first course of study treatment per protocol.
    time origin
    Up to approximately 26 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population consisted of all participants who received at least 1 dose of study treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    228
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    225
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    161
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    139
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    223
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    223
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pembrolizumab+EP
    regimen
    During each 21-day cycle, participants received pembrolizumab 200 mg intravenously (IV) on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an area under the plasma drug concentration-time curve \[AUC\] 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1). Participants who stopped pembrolizumab as a result of obtaining a response of stable disease (SD), partial response (PR), complete response (CR) or those who stopped after receiving pembrolizumab for 24 months for reasons other than disease progression or intolerability, were eligible for up to an additional 1 year of treatment after progressive disease if they met the criteria for retreatment.
    analyzed count
    223
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo+EP
    regimen
    During each 21-day cycle, participants received placebo (normal saline solution) IV on Day 1 PLUS etoposide 100 mg/m\^2 IV on Days 1, 2 and 3 PLUS investigator's choice of platinum therapy (carboplatin titrated to an AUC 5 IV on Day 1 OR cisplatin 75 mg/m\^2 IV on Day 1).
    analyzed count
    223
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03066778-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    harm key
    EG000
    source section id
    NCT03066778-ae
    event group key
    EG000
    event group label
    Pembrolizumab+EP
    serious affected
    111
    serious at risk
    223
    other affected
    221
    other at risk
    223
    frequency threshold
    5
    collection period
    First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently
    event definition
    All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    harm key
    EG001
    source section id
    NCT03066778-ae
    event group key
    EG001
    event group label
    Placebo+EP
    serious affected
    89
    serious at risk
    223
    other affected
    216
    other at risk
    223
    frequency threshold
    5
    collection period
    First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently
    event definition
    All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    harm key
    EG002
    source section id
    NCT03066778-ae
    event group key
    EG002
    event group label
    Pembrolizumab Second Course
    serious affected
    1
    serious at risk
    1
    other affected
    1
    other at risk
    1
    frequency threshold
    5
    collection period
    First Course: Up to 49.5 months Second Course: Up to 37.9 months First and second course dosing occurred concurrently
    event definition
    All-cause mortality (ACM)=all randomized participants; AE=all participants who received ≥1 dose of study treatment. Per protocol, MedDRA preferred terms neoplasm progression (NP), malignant NP, disease progression not related to study treatment are excluded. ACM was adjusted for the participant who was randomized to pembrolizumab+EP and treated with placebo+EP. AEs presented by actual treatment received. Per protocol, collection of AE and ACM were planned for first and second courses.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    qol key
    qol-0007
    source section id
    NCT03066778-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline at Week 18 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores are transformed to a range of 0 to 100 using a standard EORTC algorithm. Change from baseline scores were calculated using a constrained longitudinal data analysis (cLDA) model. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Data are presented for the first course of study treatment per protocol.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 18
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 18.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    qol key
    qol-0008
    source section id
    NCT03066778-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline at Week 12 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 12
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 12. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    qol key
    qol-0009
    source section id
    NCT03066778-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline at Week 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale
    measure definition
    EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Scores were transformed to a range of 0 to 100 using a standard EORTC algorithm. Negative change from baseline values indicated deterioration in health status or functioning and positive changes indicated improvement. Per protocol, data were to be presented for the first course of study treatment.
    time frame
    Baseline (prior to first dose of study treatment in Cycle 1 [cycle length = 21 days]) and Week 24
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants who received at least 1 dose of study medication and had non-missing assessments at baseline and Week 24. This outcome measure was replaced with a single time-point analysis at Week 18 as pre-specified with Amendment 7 of the protocol (03-Oct-2018).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-small-cell-lung-cancer
    nct id
    NCT03066778
    qol key
    qol-0010
    source section id
    NCT03066778-om-0010
    source outcome index
    10
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to True Deterioration (TTD) in the Composite Endpoint of Cough, Chest Pain, and Dyspnea Using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and Lung Cancer Module 13 (QLQ-LC13)
    measure definition
    TTD in patient-reported lung cancer symptoms of cough (QLQ-LC-13 Item 1), chest pain (QLQ-LC-13 Item 10), and dyspnea (QLQ-C30 Item 8) was a composite endpoint defined as the time to first onset of ≥10 point deterioration from baseline in an item confirmed by a second adjacent ≥10 point deterioration. The QLQ-LC13 consists of 13 measures of lung cancer symptoms and side effects from chemotherapy and radiation. It is scored on a 4-point scale (1=none, 2=a little, 3=quite a bit, 4=very much). Scores were transformed to a range of 0 to 100 using a standard algorithm. Higher scores represented increasing symptom severity. TTD was calculated using the product-limit Kaplan-Meier method for censored data and is presented for the first course of study treatment per protocol.
    time frame
    Day 1 of Cycles 1-9, Day 1 of every other cycle for Cycles 10-17 and 30 days after last dose of study treatment (Up to approximately 27 months)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    All participants who received at least 1 dose of study medication and had non-missing assessments.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice