Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and Carboplatin
- Conditions
- Lung Cancer - Non Small Cell Squamous
- Interventions
- Registration Number
- NCT01285609
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1289
- Non small cell lung cancer (NSCLC) - squamous cell
- Stage IV or recurrent NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Brain Metastases
- Autoimmune diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ipilimumab + Paclitaxel and Carboplatin 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 Placebo + Paclitaxel and Carboplatin Placebo 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 Ipilimumab + Paclitaxel and Carboplatin Ipilimumab 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 + Paclitaxel and Carboplatin Paclitaxel 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 Placebo + Paclitaxel and Carboplatin Paclitaxel 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 and Carboplatin 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (34)
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
St. Francis Hospital & Health Centers
🇺🇸Indianapolis, Indiana, United States
Durham Va Medical Center (111g)
🇺🇸Durham, North Carolina, United States
Presence Medical Group Hematology Oncology
🇺🇸Skokie, Illinois, United States
Lynn Cancer Institute Center For Hematology-Oncology
🇺🇸Boca Raton, Florida, United States
University Of Illinois At Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Southern Illinois University School Of Medicine
🇺🇸Springfield, Illinois, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Kaiser Permanente Northwest Region
🇺🇸Portland, Oregon, United States
Va Connecticut Healthcare System
🇺🇸West Haven, Connecticut, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Floyd Memorial Cancer Center Of Indiana
🇺🇸New Albany, Indiana, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Montgomery Cancer Center
🇺🇸Mount Sterling, Kentucky, United States
Washington University School Of Medicine
🇺🇸Saint Louis, Missouri, United States
Clinical Research Alliance, Inc.
🇺🇸Lake Success, New York, United States
Carolina Biooncology Institute
🇺🇸Huntersville, North Carolina, United States
Oklahoma Oncology And Hematology, Pc Dba
🇺🇸Tulsa, Oklahoma, United States
Wjb Dorn Va Medical Center
🇺🇸Columbia, South Carolina, United States
Cancer Center Of The Carolinas
🇺🇸Greenville, South Carolina, United States
Guthrie Medical Group, P.C.
🇺🇸Sayre, Pennsylvania, United States
Thompson Oncology Group
🇺🇸Knoxville, Tennessee, United States
Blue Ridge Cancer Care
🇺🇸Blacksburg, Virginia, United States
Wisconsin Institutes for Medical Research
🇺🇸Madison, Wisconsin, United States
Integrated Community Oncology Network
🇺🇸Jacksonville, Florida, United States
Associated in Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
St Joseph Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States
Novant Health Oncology Specialists
🇺🇸Lexington, North Carolina, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Local Institution
🇬🇧Sheffield, United Kingdom
University Of Kansas Cancer Center
🇺🇸Kansas City, Missouri, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Texas Oncology, PA - South Austin Cancer Center
🇺🇸Austin, Texas, United States