A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Summary
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
Arms & interventions
- BiologicalBMS-986489 (BMS-986012+Nivolumab)
Specified dose on specified days
- BiologicalAtezolizumab
Specified dose on specified days
- DrugCarboplatin
Specified dose on specified days
- DrugEtoposide
Specified dose on specified days
Outcome measures
Primary
Overall Survival (OS)
Time frame: Up to 5 years
Secondary
Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score).
Time frame: Up to 5 years
Number of participants with Adverse Events (AEs)
Time frame: Up to 135 days after last treatment
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 135 days after last treatment
Number of Participants with Adverse Events (AEs) leading to discontinuation and death
Time frame: Up to 135 days after last treatment
Objective Response (OR)
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Progression Free Survival (PFS)
Time frame: Up to 5 years
Eligibility criteria
Study locations (20)
Southern Cancer Center, PC
Daphne, Alabama, 36526
Local Institution - 0283
Hot Springs, Arkansas, 71913
Florida Cancer Specialists - South
Fort Myers, Florida, 33901
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Florida Cancer Specialists - North
St. Petersburg, Florida, 33705
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Illinois Cancer Care
Peoria, Illinois, 61615
Local Institution - 0037
Minneapolis, Minnesota, 55407
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, 87106
Duke Cancer Institute
Durham, North Carolina, 27710
Sanford Medical Center
Bismarck, North Dakota, 58501
Sanford Fargo Medical Center
Fargo, North Dakota, 58102
Oncology Hematology Care
Cincinnati, Ohio, 45242
Sanford Cancer Center
Sioux Falls, South Dakota, 57104
SCRI Oncology Partners
Nashville, Tennessee, 37203
Texas Oncology - Central/South Texas
Austin, Texas, 78705
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98026
Swedish Medical Center
Seattle, Washington, 98104