Trial · NCT01450761

Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone

NCT01450761, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2016-07-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone. Trials, record NCT01450761. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01450761

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Trial

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

Title: Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
NCT number: NCT01450761
Status: Completed
Phases: Phase 3
Enrollment: 1,351 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Small Cell Lung Carcinoma
Interventions: Ipilimumab, Placebo matching Ipilimumab, Etoposide, Cisplatin, Carboplatin
First posted: 2011-10-12
Last updated: 2020-07-08
Other registries' IDs: eudract:2011-000850-48
Results first posted: 2016-07-18

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Randomization until date of death, up to March 2015, approximately 38 months	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Secondary	Overall Survival in All Randomized Participants	From randomization until date of death, up to March 2015, approximately 38 months	Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Secondary	Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	From randomization until disease progression, up to March 2015, approximately 38 months	Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Randomization until date of death, up to March 2015, approximately 38 months	All randomized participants who received at least one dose of blinded study therapy	months	MEDIAN
SECONDARY	Overall Survival in All Randomized Participants	From randomization until date of death, up to March 2015, approximately 38 months	All randomized participants	months	MEDIAN
SECONDARY	Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	From randomization until disease progression, up to March 2015, approximately 38 months	All randomized participants who received at least one dose of blinded study therapy	months	MEDIAN

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Spread	Units
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Ipilimumab and Platinum/Etoposide	10.97	95% Confidence Interval 10.45 to 11.33	months
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy	Placebo and Platinum/Etoposide	10.94	95% Confidence Interval 10.02 to 11.50	months
Overall Survival in All Randomized Participants	Ipilimumab and Platinum/Etoposide	10.22	95% Confidence Interval 9.59 to 10.81	months
Overall Survival in All Randomized Participants	Placebo and Platinum/Etoposide	9.95	95% Confidence Interval 9.33 to 10.94	months
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	Ipilimumab and Platinum/Etoposide	4.63	95% Confidence Interval 4.50 to 4.99	months
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy	Placebo and Platinum/Etoposide	4.44	95% Confidence Interval 4.37 to 4.63	months

Source ClinicalTrials.gov

Participant flow18

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

Period	Milestone	Group	Participants
Randomization	STARTED	Ipilimumab and Platinum/Etoposide	566
Randomization	STARTED	Placebo and Platinum/Etoposide	566
Randomization	COMPLETED	Ipilimumab and Platinum/Etoposide	562
Randomization	COMPLETED	Placebo and Platinum/Etoposide	561
Randomization	NOT COMPLETED	Ipilimumab and Platinum/Etoposide	4
Randomization	NOT COMPLETED	Placebo and Platinum/Etoposide	5
Lead-in Chemotherapy	STARTED	Ipilimumab and Platinum/Etoposide	562
Lead-in Chemotherapy	STARTED	Placebo and Platinum/Etoposide	561
Lead-in Chemotherapy	COMPLETED	Ipilimumab and Platinum/Etoposide	478
Lead-in Chemotherapy	COMPLETED	Placebo and Platinum/Etoposide	476

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events624

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	Chest pain	General disorders	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	38	562
other	Chest pain	General disorders	PLACEBO + PLATINUM/ETOPOSIDE	45	561
other	Neutrophil count decreased	Investigations	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	87	562
other	Neutrophil count decreased	Investigations	PLACEBO + PLATINUM/ETOPOSIDE	67	561
other	Weight decreased	Investigations	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	46	562
other	Weight decreased	Investigations	PLACEBO + PLATINUM/ETOPOSIDE	41	561
other	Back pain	Musculoskeletal and connective tissue disorders	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	43	562
other	Back pain	Musculoskeletal and connective tissue disorders	PLACEBO + PLATINUM/ETOPOSIDE	47	561
other	Cough	Respiratory, thoracic and mediastinal disorders	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	94	562
other	Cough	Respiratory, thoracic and mediastinal disorders	PLACEBO + PLATINUM/ETOPOSIDE	81	561

1 to 10 of 624Source ClinicalTrials.gov

See all 624 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE
Total, all-cause mortality	PLACEBO + PLATINUM/ETOPOSIDE
Total, other adverse events	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	519	562
Total, other adverse events	PLACEBO + PLATINUM/ETOPOSIDE	520	561
Total, serious adverse events	10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE	316	562
Total, serious adverse events	PLACEBO + PLATINUM/ETOPOSIDE	278	561

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27458307	DERIVED

Source 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 comparisons1

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

Comparison
10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE vs PLACEBO + PLATINUM/ETOPOSIDE: serious adverse events

Source Trial comparisons

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01450761

GET https://conductscience.org/api/trials/v1/NCT01450761/events?page=2

API reference For AI assistants