Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
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ClinicalTrials.gov Identifier: NCT01285609 |
Recruitment Status
:
Completed
First Posted
: January 28, 2011
Results First Posted
: June 23, 2016
Last Update Posted
: December 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Cancer - Non Small Cell Squamous | Drug: Ipilimumab Drug: Placebo Drug: Paclitaxel Drug: Carboplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1289 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non Small Cell Lung Cancer (NSCLC) |
Actual Study Start Date : | January 16, 2011 |
Actual Primary Completion Date : | June 9, 2015 |
Actual Study Completion Date : | August 22, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Ipilimumab + Paclitaxel and Carboplatin
Ipilimumab + Active Chemo Backbone Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
Drug: Ipilimumab
Other Name: BMS-734016
Drug: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®
|
Placebo Comparator: Placebo + Paclitaxel and Carboplatin
Placebo + Active Chemo Backbone Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose) Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses |
Drug: Placebo
Drug: Paclitaxel
Other Name: Taxol®
Drug: Carboplatin
Other Name: Paraplatin®
|
- Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy at Primary Endpoint [ Time Frame: Randomization until 518 deaths, 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. Interim 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.
- Overall Survival (OS) in All Randomized Participants at Primary Endpoint [ Time Frame: Randomization until 705 deaths, 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. Interim 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.
- 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 [ Time Frame: Randomization until 518 deaths, 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion Criteria:
- Brain Metastases
- Autoimmune diseases

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285609

Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01285609 History of Changes |
Other Study ID Numbers: |
CA184-104 2009-017396-19 ( EudraCT Number ) |
First Posted: | January 28, 2011 Key Record Dates |
Results First Posted: | June 23, 2016 |
Last Update Posted: | December 13, 2017 |
Last Verified: | November 2017 |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel |
Albumin-Bound Paclitaxel Carboplatin Antibodies, Monoclonal Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |