Trial · NCT02538666

An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy

NCT02538666, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2019-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy. Trials, record NCT02538666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02538666

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Investigational Immuno-therapy Study of Nivolumab, or Nivolumab in Combination With Ipilimumab, or Placebo in Patients With Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) After Completion of Platinum-based Chemotherapy
NCT number: NCT02538666
Status: Completed
Phases: Phase 3
Enrollment: 907 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Lung Cancer
Interventions: Nivolumab, Ipilimumab, Placebo
First posted: 2015-09-02
Last updated: 2023-01-05
Other registries' IDs: eudract:2015-002441-61
Results first posted: 2019-10-22

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)	OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug
Secondary	Overall Survival (OS) of Nivolumab Versus Placebo	From randomization to the date of death or last known alive date (up to approximately 73 months)	Overall Survival (OS) comparing nivolumab monotherapy versus placebo. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Secondary	Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	From randomization to the date of death or last known alive date (up to approximately 73 months)	Overall Survival (OS) comparing Nivolumab + Ipilimumab Versus Nivolumab. OS was defined as the time from randomization to the date of death. A participant who had not died was censored at last known alive date. OS was followed up during the blinded study drug treatment and every 3 months via in-person or phone contact after participant discontinued the blinded study drug.
Secondary	Progression Free Survival (PFS) Per BICR	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	PFS was defined as the time between the date of randomization and the first date of documented progression as determined by Blind Independent Central Review (BICR) or death due to any cause, whichever occurred first. Participants who died with no reported progression were considered to have progressed on the date of death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy. Participants who did not have any on study tumor assessments and did not die (or died after initiation of the subsequent anti- cancer therapy) were censored on their date of randomization. Participants who started any subsequent anti- cancer therapy without a prior reported Progressive Disease (PD) per BICR were censored at the last evaluable tumor assessment on or prior to initiation of the subsequent anti-cancer therapy.
Secondary	Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of death or last known alive date (up to approximately 73 months)	Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. OS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb
Secondary	Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	Tumor mutational burden (TMB) is measured using FoundationOne CDxTM (F1CDx) assay, a comprehensive genomic profile (CGP) assay based on baseline tumor tissue. TMB is defined as the number of somatic, coding, base substitution, and indel mutations per megabase of genome examined. PFS in TMB by the following cutoff points: ≥10 mutations/mb, \< 10 mutations/mb, ≥13 mutations/mb, \<13 mutations/mb.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	From randomization to 400 deaths across the two treatment groups (Nivo+Ipi vs Placebo) (up to approximately 37 months)	All randomized participants in the nivolumab + ipilimumab and placebo arms in the global population	Months	MEDIAN
SECONDARY	Overall Survival (OS) of Nivolumab Versus Placebo	From randomization to the date of death or last known alive date (up to approximately 73 months)	All randomized participants in the nivolumab monotherapy and placebo arms	Months	MEDIAN
SECONDARY	Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	From randomization to the date of death or last known alive date (up to approximately 73 months)	All randomized participants in the Nivolumab + Ipilimumab and Nivolumab arms	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS) Per BICR	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	All randomized participants	Months	MEDIAN
SECONDARY	Overall Survival (OS) in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of death or last known alive date (up to approximately 73 months)	All TMB evaluable participants in the global population	Months	MEDIAN
SECONDARY	Progression Free Survival (PFS) Per BICR in Tumor Mutational Burden (TMB) High and Low Subgroups by TMB Cutoff In The Global Population	From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 73 months)	All TMB evaluable participants in the global population	Months	MEDIAN
POST_HOC	Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo - Extended Collection	From randomization to the date of death or last known alive date (up to approximately 73 months)	All randomized participants in the nivolumab + ipilimumab and placebo arms	Months	MEDIAN

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	Global Placebo	9.56	95% Confidence Interval 8.18 to 11.01	Months
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Placebo In The Global Population	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	9.17	95% Confidence Interval 8.15 to 10.25	Months
Overall Survival (OS) of Nivolumab Versus Placebo	Global Placebo	9.56	95% Confidence Interval 8.18 to 11.01	Months
Overall Survival (OS) of Nivolumab Versus Placebo	Global Nivolumab 240 mg	10.18	95% Confidence Interval 9.43 to 11.99	Months
Overall Survival (OS) of Nivolumab Versus Placebo	China Placebo	9.28	95% Confidence Interval 5.59 to 14.26	Months
Overall Survival (OS) of Nivolumab Versus Placebo	China Nivolumab 240 mg	8.18	95% Confidence Interval 7.20 to 14.26	Months
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	Global Nivolumab 240 mg	10.18	95% Confidence Interval 9.43 to 11.99	Months
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	9.17	95% Confidence Interval 8.15 to 10.35	Months
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	China Nivolumab 240 mg	8.18	95% Confidence Interval 7.20 to 14.26	Months
Overall Survival (OS) of Nivolumab + Ipilimumab Versus Nivolumab	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	10.48	95% Confidence Interval 7.13 to 13.40	Months

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment	STARTED	Placebo	300
Pre-Treatment	STARTED	Nivolumab 240 mg	304
Pre-Treatment	STARTED	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	303
Pre-Treatment	Global	Placebo	275
Pre-Treatment	Global	Nivolumab 240 mg	280
Pre-Treatment	Global	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	279
Pre-Treatment	China	Placebo	26
Pre-Treatment	China	Nivolumab 240 mg	25
Pre-Treatment	China	Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	24
Pre-Treatment	COMPLETED	Placebo	298

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events2,052

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Global Placebo	31	273
other	Anaemia	Blood and lymphatic system disorders	Global Nivolumab 240 mg	30	279
other	Anaemia	Blood and lymphatic system disorders	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	25	278
other	Anaemia	Blood and lymphatic system disorders	China Placebo	10	26
other	Anaemia	Blood and lymphatic system disorders	China Nivolumab 240 mg	4	25
other	Anaemia	Blood and lymphatic system disorders	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	12	24
other	Leukocytosis	Blood and lymphatic system disorders	Global Placebo	0	273
other	Leukocytosis	Blood and lymphatic system disorders	Global Nivolumab 240 mg	0	279
other	Leukocytosis	Blood and lymphatic system disorders	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	0	278
other	Leukocytosis	Blood and lymphatic system disorders	China Placebo	0	26

1 to 10 of 2,052Source ClinicalTrials.gov

See all 2,052 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Global Placebo	250	275
Total, all-cause mortality	Global Nivolumab 240 mg	231	280
Total, all-cause mortality	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	240	279
Total, all-cause mortality	China Placebo	24	26
Total, all-cause mortality	China Nivolumab 240 mg	23	25
Total, all-cause mortality	China Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	23	24
Total, other adverse events	Global Placebo	228	273
Total, other adverse events	Global Nivolumab 240 mg	244	279
Total, other adverse events	Global Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg	263	278
Total, other adverse events	China Placebo	22	26

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33683919	DERIVED	PubMed
35383114	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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