Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
18 Years
N/A
Both
Small Cell Lung Carcinoma
Trial Information
Randomized, Multicenter, Double-Blind, Phase 3 Trial Comparing the Efficacy of Ipilimumab Plus Etoposide/Platinum Versus Etoposide/Platinum in Subjects With Newly Diagnosed Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
Inclusion Criteria:
- Extensive-Stage Disease Small Cell Lung Cancer (ED-SCLC)
- Eastern Cooperative Oncology Group (ECOG) of 0 or 1
Exclusion Criteria:
- Prior systemic therapy for lung cancer
- Symptomatic Central Nervous System (CNS) metastases
- History of autoimmune disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
After 816 Death Events have been observed (Interim analysis after 612 death events)
Outcome Time Frame:
Approximately 40.8 months after the first subject is randomized
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CA184-156
NCT ID:
NCT01450761
Start Date:
January 2012
Completion Date:
March 2017
Related Keywords:
- Small Cell Lung Carcinoma
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| SIU School of Medicine | Springfield, Illinois 62702 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Genesis Cancer Center | Hot Springs, Arkansas 71913 |
| Tennessee Cancer Specialists | Knoxville, Tennessee 37920 |
| Cancer Care Associates | Tulsa, Oklahoma 74136 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| UCSD Moores Cancer Center | La Jolla, California 93093 |
| Vanderbilt Ingram Cancer Center | Nashville, Tennessee 37232 |
| Kaiser Permanente | Portland, Oregon 97227 |
| Peninsula Cancer Institute | Newport News, Virginia 23601 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
| St. Francis Medical Group Oncology And Hematology Specialist | Indianapolis, Indiana 46237 |
| Montgomery Cancer Center | Mt. Sterling, Kentucky 40353 |
| University of Kentucky Markey Cancer Center | Lexington, Kentucky 40536 |
| Mid-Ohio Oncology/Hematology, Inc. Dba | Columbus, Ohio 43219 |
| The Jones Clinic, Pc | Germantown, Tennessee 38138 |
| Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
| Quincy Medical Group | Quincy, Illinois 62301 |
| St. Luke's Cancer Institute | Kansas City, Missouri 64111 |
| Huntsman Cancer Institute At The Univ. Of Utah | Salt Lake City, Utah 84112 |
| Orchard Healthcare Research Inc. | Skokie, Illinois 60076 |
| Floyd Memorial Cancer Center of Indiana | New Albany, Indiana 47150 |
| Cancer Care Of North Florida, Pa | Lake City, Florida 32024 |
| Medical Oncology Associates Of Augusta,Pc | Augusta, Georgia 30901 |
| Ashland Bellefonte Cancer Center | Ashland, Kentucky 41101 |
| Mary Bird Perkins | Baton Rouge, Louisiana 70809 |
| Southeast Nebraska Hematology & Oncology Consultants, P.C. | Lincoln, Nebraska 68510 |
| The Center For Cancer & Hematologic Diseases | Cherry Hill, New Jersey 08003 |
| Cancer Specialists Of North Florida Beaches | Jacksonville, Florida 32256 |
| St Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
| Mercy Physicians Of Oklahoma Inc | Oklahoma City, Oklahoma 73120 |
| Wvu Hospitals | Morgantown, West Virginia 26506 |
