About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale.
Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system
Disqualifiers
Participants have already received certain types of treatment for extensive stage small cell lung cancer
Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy
Other protocol-defined Inclusion/Exclusion criteria apply.
Trial design
Parallel
Treatments tested in this trial
BMS-986489 (Atigotatug+Nivolumab)
Biological/VaccineSpecified dose on specified days
Atezolizumab
Biological/VaccineSpecified dose on specified days
Carboplatin
DrugSpecified dose on specified days
Etoposide
DrugSpecified dose on specified days
Treatment groups
Trial outcomes
Primary outcomes
Overall Survival (OS)
Secondary outcomes
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).
Number of participants with Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Adverse Events (AEs) leading to discontinuation and death
Sponsors and contacts
Click on the lead sponsor to view all of their trials.