NCT06646276RecruitingPhase 3
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).
Bristol-Myers Squibb338 sites in 8 countries530 target enrollmentStarted: February 25, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 530
- Locations
- 338
- Primary Endpoint
- Overall Survival (OS)
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm A
Experimental
Intervention: BMS-986489 (Atigotatug+Nivolumab) (Biological)
Arm A
Experimental
Intervention: Carboplatin (Drug)
Arm B
Active Comparator
Intervention: Atezolizumab (Biological)
Arm A
Experimental
Intervention: Etoposide (Drug)
Arm B
Active Comparator
Intervention: Carboplatin (Drug)
Arm B
Active Comparator
Intervention: Etoposide (Drug)
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to 5 years
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).(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)
Investigators
Study Sites (338)
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