Overview

This trial is active, not recruiting.

Condition lung cancer - non small cell
Treatments ipilimumab, placebo, paclitaxel, carboplatin
Phase phase 3
Target CTLA-4
Sponsor Bristol-Myers Squibb
Start date January 2011
End date June 2015
Trial size 920 participants
Trial identifier NCT01285609, 2009-017396-19, CA184-104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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
ipilimumab BMS-734016
paclitaxel Taxol®
carboplatin Paraplatin®
(Placebo Comparator)
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
placebo
paclitaxel Taxol®
carboplatin Paraplatin®

Primary Outcomes

Measure
Overall Survival (OS) in Subjects who have received at least one dose of blinded study therapy
time frame: Approximately 48 months post study start

Secondary Outcomes

Measure
Overall Survival in all Randomized Subjects
time frame: Approximately 42 months post study start
Progression Free Survival per mWHO in subjects who have received at least one dose of blinded study therapy
time frame: Approximately 42 months post study start

Eligibility Criteria

Male or female participants at least 18 years old.

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) of 0 or 1 Exclusion Criteria: - Brain Metastases - Autoimmune diseases

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.