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).

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Extensive-Stage Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Etoposide; Biological: Atezolizumab; Biological: BMS-986489 (BMS-986012+Nivolumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06646276

CA245-0001

Details and patient eligibility

About

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.

Enrollment: 530 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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530 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Biological: BMS-986489 (BMS-986012+Nivolumab)

Drug: Etoposide

Drug: Carboplatin

Arm B

Active Comparator group

Treatment:

Drug: Etoposide

Biological: Atezolizumab

Drug: Carboplatin