Trial · NCT01285609

Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin

NCT01285609, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2016-06-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin. Trials, record NCT01285609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01285609

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Trial

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

Title: Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
NCT number: NCT01285609
Status: Completed
Phases: Phase 3
Enrollment: 1,289 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Lung Cancer - Non Small Cell Squamous
Interventions: Ipilimumab, Placebo, Paclitaxel, Carboplatin
First posted: 2011-01-28
Last updated: 2020-06-18
Other registries' IDs: eudract:2009-017396-19
Results first posted: 2016-06-23

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 at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Secondary	Overall Survival (OS) in All Randomized Participants at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	Overall Survival (OS) was defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS time was calculated using Kaplan-Meier Estimates. Analysis for the Primary Endpoint occurred when the following 2 conditions were both met: (1) 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and (2) 705 deaths were observed in all randomized participants.
Secondary	Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	Progression-free survival (PFS) is defined as the time between the date of randomization and the date of tumor progression per Modified World Health Organization (mWHO) criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria were considered to have progressed on the date of death. For participants who remain alive and have not progressed, PFS was censored on the date of last evaluable tumor assessment. For participants who remain alive and have 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 at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	All treated participants who received at least one dose of blinded therapy	months	MEDIAN
SECONDARY	Overall Survival (OS) in All Randomized Participants at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	All randomized participants	months	MEDIAN
SECONDARY	Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Randomization until 518 deaths were observed in randomized participants treated with at least one dose of blinded study therapy and 705 deaths were observed in all randomized participants, up to June 2015 (approximately 48 months post study start)	All treated participants who received at least one dose of blinded 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 at Primary Endpoint	Ipilimumab With Paclitaxel/Carboplatin	13.37	95% Confidence Interval 11.76 to 14.78	months
Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Placebo With Paclitaxel/Carboplatin	12.42	95% Confidence Interval 11.60 to 13.63	months
Overall Survival (OS) in All Randomized Participants at Primary Endpoint	Ipilimumab With Paclitaxel/Carboplatin	10.94	95% Confidence Interval 9.56 to 12.02	months
Overall Survival (OS) in All Randomized Participants at Primary Endpoint	Placebo With Paclitaxel/Carboplatin	10.74	95% Confidence Interval 9.66 to 11.73	months
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Ipilimumab With Paclitaxel/Carboplatin	5.55	95% Confidence Interval 5.36 to 5.85	months
Median Number of Months With Progression Free Survival (PFS) Per mWHO in Participants Who Have Received at Least One Dose of Blinded Study Therapy at Primary Endpoint	Placebo With Paclitaxel/Carboplatin	5.59	95% Confidence Interval 5.52 to 5.72	months

Source ClinicalTrials.gov

Participant flow14

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

Period	Milestone	Group	Participants
Randomized	STARTED	Ipilimumab With Paclitaxel/Carboplatin	479
Randomized	STARTED	Placebo With Paclitaxel/Carboplatin	477
Randomized	Treated With Chemotherapy (1st Dose)	Ipilimumab With Paclitaxel/Carboplatin	475
Randomized	Treated With Chemotherapy (1st Dose)	Placebo With Paclitaxel/Carboplatin	473
Randomized	COMPLETED	Ipilimumab With Paclitaxel/Carboplatin	388
Randomized	COMPLETED	Placebo With Paclitaxel/Carboplatin	361
Randomized	NOT COMPLETED	Ipilimumab With Paclitaxel/Carboplatin	91
Randomized	NOT COMPLETED	Placebo With Paclitaxel/Carboplatin	116
Treated With Blinded Therapy	STARTED	Ipilimumab With Paclitaxel/Carboplatin	388
Treated With Blinded Therapy	STARTED	Placebo With Paclitaxel/Carboplatin	361

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events730

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	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	171	475
other	Anaemia	Blood and lymphatic system disorders	Placebo + Paclitaxel/ Carboplatin	157	473
other	Decreased appetite	Metabolism and nutrition disorders	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	145	475
other	Decreased appetite	Metabolism and nutrition disorders	Placebo + Paclitaxel/ Carboplatin	116	473
other	Haemoglobin decreased	Investigations	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	38	475
other	Haemoglobin decreased	Investigations	Placebo + Paclitaxel/ Carboplatin	30	473
other	Myalgia	Musculoskeletal and connective tissue disorders	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	66	475
other	Myalgia	Musculoskeletal and connective tissue disorders	Placebo + Paclitaxel/ Carboplatin	61	473
other	Oedema peripheral	General disorders	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	25	475
other	Oedema peripheral	General disorders	Placebo + Paclitaxel/ Carboplatin	31	473

1 to 10 of 730Source ClinicalTrials.gov

See all 730 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 + Paclitaxel/ Carbop	359	475
Total, all-cause mortality	Placebo + Paclitaxel/ Carboplatin	371	473
Total, other adverse events	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	437	475
Total, other adverse events	Placebo + Paclitaxel/ Carboplatin	428	473
Total, serious adverse events	10 MG/KG Ipilimumab + Paclitaxel/ Carbop	300	475
Total, serious adverse events	Placebo + Paclitaxel/ Carboplatin	235	473

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons2

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

Comparison	Source
10 MG/KG Ipilimumab + Paclitaxel/ Carbop vs Placebo + Paclitaxel/ Carboplatin: deaths from any cause	Trial comparisons
10 MG/KG Ipilimumab + Paclitaxel/ Carbop vs Placebo + Paclitaxel/ Carboplatin: serious adverse events	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/NCT01285609

GET https://conductscience.org/api/trials/v1/NCT01285609/events?page=2

API reference For AI assistants