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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
530
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Southern Cancer Center, PC
Daphne, Alabama, United States
RECRUITINGLocal Institution - 0283
Hot Springs, Arkansas, United States
COMPLETEDFlorida Cancer Specialists - South
Fort Myers, Florida, United States
RECRUITINGMid Florida Hematology and Oncology Center
Orange City, Florida, United States
Overall Survival (OS)
Time frame: Up to 5 years
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
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Florida Cancer Specialists - North
St. Petersburg, Florida, United States
RECRUITINGNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
RECRUITINGIllinois Cancer Care
Peoria, Illinois, United States
RECRUITINGLocal Institution - 0037
Minneapolis, Minnesota, United States
WITHDRAWNUniversity of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
RECRUITINGDuke Cancer Institute
Durham, North Carolina, United States
RECRUITING...and 173 more locations