Clinical Trial: NCT06646276
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ 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).
Status:
RECRUITINGPhase:
Phase 3| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-10-13 |
Study Overview
Brief 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.
Official Title
A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+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).
Conditions
Extensive-Stage Small Cell Lung Cancer
Intervention / Treatment
- Biological: BMS-986489 (Atigotatug+Nivolumab)
- Biological: Atezolizumab
- Drug: Carboplatin
- Drug: Etoposide
Other Study ID Numbers
- CA245-0001
- 2024-515740-23
- U1111-1308-1151
Start Date (Actual)
2025-02-25
Primary Completion Date (Estimated)
2027-08-17
Study Completion Date (Estimated)
2031-07-14
Enrollment (Estimated)
530
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | Bristol-Myers Squibb |
| Information Provided By: | Bristol-Myers Squibb |
| Last Update Posted: | 2026-10-13 |
Study Overview
Brief 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.
Official Title
A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+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).
Conditions
Extensive-Stage Small Cell Lung Cancer
Intervention / Treatment
- Biological: BMS-986489 (Atigotatug+Nivolumab)
- Biological: Atezolizumab
- Drug: Carboplatin
- Drug: Etoposide
Other Study ID Numbers
- CA245-0001
- 2024-515740-23
- U1111-1308-1151
Start Date (Actual)
2025-02-25
Primary Completion Date (Estimated)
2027-08-17
Study Completion Date (Estimated)
2031-07-14
Enrollment (Estimated)
530
Study Type
Interventional
Phase
Phase 3