NCT06646276

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).

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).

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 530 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BMS-986489 (BMS-986012+Nivolumab)	Specified dose on specified days
BIOLOGICAL	Atezolizumab	Specified dose on specified days
DRUG	Carboplatin	Specified dose on specified days
DRUG	Etoposide	Specified dose on specified days

Timeline

• Start date: 2025-02-25
• Primary completion: 2028-04-06
• Completion: 2031-09-05
• First posted: 2024-10-17
• Last updated: 2026-04-03

Locations

184 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, India, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study