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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) logo

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment in 1 month
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

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

Trial contacts and locations

153

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Central trial contact

First line of the email MUST contain the NCT# and Site#; BMS Clinical Trials Contact Center www.BMSClinicaltrials.com

Data sourced from clinicaltrials.gov

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