Trial in Extensive-Disease Small Cell Lung Cancer (ED-SCLC) Subjects Comparing Ipilimumab Plus Etoposide and Platinum Therapy to Etoposide and Platinum Therapy Alone
- Conditions
- Small Cell Lung Carcinoma
- Interventions
- Biological: Placebo matching IpilimumabBiological: IpilimumabDrug: EtoposideDrug: CisplatinDrug: Carboplatin
- Registration Number
- NCT01450761
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of the study is to determine whether the addition of Ipilimumab to Etoposide and Platinum therapy will extend the lives of patients with Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC) more than Etoposide and Platinum therapy alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1351
- Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
- Prior systemic therapy for lung cancer
- Symptomatic Central Nervous System (CNS) metastases
- History of autoimmune disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin Placebo matching Ipilimumab Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Ipilimumab+Etoposide+Cisplatin/Carboplatin Cisplatin Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Ipilimumab+Etoposide+Cisplatin/Carboplatin Ipilimumab Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Ipilimumab+Etoposide+Cisplatin/Carboplatin Etoposide Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Ipilimumab+Etoposide+Cisplatin/Carboplatin Carboplatin Ipilimumab: IV solution, Intravenous (IV), 10 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin Etoposide Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin Carboplatin Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses Placebo matching Ipilimumab+Etoposide+Cisplatin/Carboplatin Cisplatin Placebo matching Ipilimumab: IV solution, IV, 0 mg/kg, Once every 3 weeks for 4 doses, then every 12 weeks, Until progression of disease or unacceptable toxicity, or until the maximum treatment period of 3 years is reached Etoposide: IV solution, IV, 100 mg/m2, Days 1-3 every 3 weeks, 4 cycles Cisplatin: IV solution, IV, 75 mg/m2, Once every 3 weeks, 4 doses Carboplatin: IV Solution, IV, Area Under the Curve (AUC) 5, Once every 3 weeks, 4 doses
- Primary Outcome Measures
Name Time Method Overall Survival (OS) in Participants Who Received at Least One Dose of Blinded Study Therapy Randomization until date of death, up to March 2015, approximately 38 months Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
- Secondary Outcome Measures
Name Time Method Overall Survival in All Randomized Participants From randomization until date of death, up to March 2015, approximately 38 months Overall Survival was defined as the time from the date of randomization until the date of death from any cause. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Progression Free Survival (PFS) Time in Participants Who Have Received at Least One Dose of Blinded Study Therapy From randomization until disease progression, up to March 2015, approximately 38 months Progression-Free Survival was defined as the time from the date of randomization to the date of progression per modified World Health Organization (mWHO) criteria or death, whichever occured first. A participant who died without reported progression per mWHO criteria was considered progressed on the date of death. For those participants who remained alive and did not progress, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Trial Locations
- Locations (43)
University Of Texas, M. D. Anderson Cancer Center
🇺🇸Houston, Texas, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Mary Babb Randolph Cancer Center
🇺🇸Morgantown, West Virginia, United States
The Jones Clinic, PC
🇺🇸Germantown, Tennessee, United States
Presence Medical Group Hematology Oncology
🇺🇸Skokie, Illinois, United States
Medical Oncology, LLC
🇺🇸Augusta, Georgia, United States
Tennessee Oncology, PLLC
🇺🇸Nashville, Tennessee, United States
Local Institution
🇬🇧Truro, United Kingdom
Chattanooga Oncology Hematology Associates
🇺🇸Chattanooga, Tennessee, United States
Tennessee Cancer Specialists
🇺🇸Knoxville, Tennessee, United States
Florida Cancer Specialists S.
🇺🇸Fort Myers, Florida, United States
Thompson Cancer Survival Center
🇺🇸Knoxville, Tennessee, United States
Sutter Medical Center
🇺🇸Auburn, California, United States
Lake City Cancer Care
🇺🇸Lake City, Florida, United States
St Joseph Mercy Hospital
🇺🇸Ypsilanti, Michigan, United States
Associated in Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
University Of Kentucky
🇺🇸Lexington, Kentucky, United States
UCSD Moores Cancer Center
🇺🇸La Jolla, California, United States
Genesis Cancer Center
🇺🇸Hot Springs, Arkansas, United States
Quincy Medical Group
🇺🇸Quincy, Illinois, United States
Cancer Center Of Kansas
🇺🇸Wichita, Kansas, United States
Oncology Hematology Care, Incorporated
🇺🇸Cincinnati, Ohio, United States
Henry-Joyce Cancer Center
🇺🇸Nashville, Tennessee, United States
Huntsman Cancer Hospital
🇺🇸Salt Lake City, Utah, United States
Southeast Nebraska Hematology & Oncology Consultants, P.C.
🇺🇸Lincoln, Nebraska, United States
Regional Cancer Care Associates, LLC/Cherry Hill Division
🇺🇸Cherry Hill, New Jersey, United States
Memorial Sloan Kettering Nassau
🇺🇸New York, New York, United States
Oklahoma Cancer Specialists and Research Institute, LLC
🇺🇸Tulsa, Oklahoma, United States
Cancer Specialists, LLC
🇺🇸Jacksonville, Florida, United States
Florida Cancer Specialists
🇺🇸Saint Petersburg, Florida, United States
SIU School Of Medicine
🇺🇸Springfield, Illinois, United States
St. Francis Medical Group Oncology And Hematology Specialist
🇺🇸Indianapolis, Indiana, United States
Montgomery Cancer Center
🇺🇸Mount Sterling, Kentucky, United States
Ashland Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Signal Point Clinical Research Center, Llc
🇺🇸Middletown, Ohio, United States
Joe Arrington Cancer Research And Treatment Center
🇺🇸Lubbock, Texas, United States
St. Luke'S Cancer Institute
🇺🇸Kansas City, Missouri, United States
University Of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Kaiser Permanente
🇺🇸Portland, Oregon, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States