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

Study Description

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Brief Summary:

The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the lives of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.

Condition or disease	Intervention/treatment	Phase
Lung Cancer - Non Small Cell Squamous	Drug: Ipilimumab; Drug: Placebo; Drug: Paclitaxel; Drug: Carboplatin	Phase 3

Detailed Description:

The primary objective is to compare Overall Survival (OS) of participants with Stage IV/recurrent NSCLC of squamous histology who have been randomized to ipilimumab in addition to paclitaxel and carboplatin versus placebo in addition to paclitaxel and carboplatin, and have received at least one dose of blinded study therapy (ipilimumab or placebo).

Study Design

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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

Arms and Interventions

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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®

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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  Show 285 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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Additional Information:

BMS Clinical Trial Information 

FDA Safety Alerts and Recalls 

BMS Clinical Trial Patient Recruiting 

Investigator Inquiry Form 

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
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