A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ 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 (TIGOS).
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT06646276
This clinical trial evaluates the efficacy and safety of BMS-986489 combined with carboplatin and etoposide versus atezolizumab with the same drugs in treating extensive-stage small cell lung cancer. Eligible participants must have measurable tumors outside the brain and be able to perform daily activities independently. Interventions include specified doses of biologicals and drugs.
Patient Parameters
| Parameter | Options |
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Program Overview
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
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Genesis Cancer and Blood Institute | 71913 | Hot Springs | Arkansas |
| Florida Cancer Specialists - South | 33901 | Fort Myers | Florida |
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Florida Cancer Specialists - North | 33705 | Saint Petersburg | Florida |
| Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | 30060 | Marietta | Georgia |
| Illinois Cancer Care | 61615 | Peoria | Illinois |
| Local Institution - 0037 | 55407 | Minneapolis | Minnesota |
| Local Institution - 0033 | 87106 | Albuquerque | New Mexico |
| Local Institution - 0029 | 27710 | Durham | North Carolina |
| Local Institution - 0284 | 45242 | Cincinnati | Ohio |
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