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).

Phase 3

Recruiting

• Conditions: Extensive-Stage Small Cell Lung Cancer
• Interventions: Biological: BMS-986489 (BMS-986012+Nivolumab); Biological: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

• Registration Number: NCT06646276
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-16
• Study First Submitted QC: 2024-10-16
• Study First Posted: 2024-10-17
• Study Start: 2025-02-25
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-03
• Last Update Posted: 2025-09-04
• Primary Completion: 2028-04-06
• Study Completion: 2031-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	BMS-986489 (BMS-986012+Nivolumab)	-
Arm A	Carboplatin	-
Arm A	Etoposide	-
Arm B	Atezolizumab	-
Arm B	Carboplatin	-
Arm B	Etoposide	-

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
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).	Up to 5 years
Number of participants with Adverse Events (AEs)	Up to 135 days after last treatment
Number of Participants with Serious Adverse Events (SAEs)	Up to 135 days after last treatment
Number of Participants with Adverse Events (AEs) leading to discontinuation and death	Up to 135 days after last treatment
Objective Response (OR)	Up to 5 years
Duration of Response (DOR)	Up to 5 years
Progression Free Survival (PFS)	Up to 5 years

Trial Locations

Locations (191)

Hospital São Lucas da PUCRS; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

Tongji Hospital Tongji Medical,Science & Technology; 🇨🇳 Wuhan, Hubei, China

Sarawak General Hospital; 🇲🇾 Kuching, Sarawak, Malaysia

Southern Cancer Center, PC; 🇺🇸 Daphne, Alabama, United States

Local Institution - 0283; 🇺🇸 Hot Springs, Arkansas, United States

Florida Cancer Specialists - South; 🇺🇸 Fort Myers, Florida, United States

Mid Florida Hematology and Oncology Center; 🇺🇸 Orange City, Florida, United States

Florida Cancer Specialists - North; 🇺🇸 St. Petersburg, Florida, United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital; 🇺🇸 Marietta, Georgia, United States

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