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).

Description

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.

Conditions

Extensive-Stage Small Cell Lung Cancer

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Study Overview

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Study Details

Study overview

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.

A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (BMS-986012+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).

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).

Condition
Extensive-Stage Small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

Fort Myers

Local Institution - 0245, Fort Myers, Florida, United States, 33901

Orange City

Mid Florida Hematology and Oncology Center, Orange City, Florida, United States, 32763

Saint Petersburg

Local Institution - 0020, Saint Petersburg, Florida, United States, 33705

Marietta

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital, Marietta, Georgia, United States, 30060

Minneapolis

Local Institution - 0037, Minneapolis, Minnesota, United States, 55407

Albuquerque

Local Institution - 0033, Albuquerque, New Mexico, United States, 87106

Durham

Local Institution - 0029, Durham, North Carolina, United States, 27710

Cincinnati

Local Institution - 0284, Cincinnati, Ohio, United States, 45242

Sioux Falls

Local Institution - 0231, Sioux Falls, South Dakota, United States, 57104

Knoxville

Local Institution - 0307, Knoxville, Tennessee, United States, 37909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2031-09-05