RECRUITING

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).

Conditions

Extensive-Stage Small Cell Lung Cancer BMS-986489 BMS-986012 Etoposide Carboplatin Nivolumab TIGOS fucGM1 SCLC ES-SCLC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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).

Quick Facts

Study Start:2025-01-31

Study Completion:2031-09-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06646276

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicaltrials.com

CONTACT

855-907-3286

Clinical.Trials@BMS.com

First line of the email MUST contain the NCT# and Site#

CONTACT

Principal Investigator

Bristol-Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0245

Fort Myers, Florida, 33901

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763

United States

Local Institution - 0020

Saint Petersburg, Florida, 33705

United States

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, 30060

United States

Local Institution - 0037

Minneapolis, Minnesota, 55407

United States

Local Institution - 0033

Albuquerque, New Mexico, 87106

United States

Local Institution - 0029

Durham, North Carolina, 27710

United States

Local Institution - 0284

Cincinnati, Ohio, 45242

United States

Local Institution - 0231

Sioux Falls, South Dakota, 57104

United States

Local Institution - 0307

Knoxville, Tennessee, 37909

United States

Local Institution - 0008

Nashville, Tennessee, 37203

United States

Local Institution - 0001

Austin, Texas, 78731

United States

Local Institution - 0281

Tyler, Texas, 75702

United States

Local Institution - 0246

Roanoke, Virginia, 24014

United States

Local Institution - 0026

Seattle, Washington, 98104

United States

Local Institution - 0007

Tacoma, Washington, 98405

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-31

Study Completion Date2031-09-05

Study Record Updates

Study Start Date2025-01-31

Study Completion Date2031-09-05

Terms related to this study

Keywords Provided by Researchers

BMS-986489
BMS-986012
Extensive-Stage Small Cell Lung Cancer
Etoposide
Carboplatin
Nivolumab
TIGOS
fucGM1
SCLC
ES-SCLC

Additional Relevant MeSH Terms

Extensive-Stage Small Cell Lung Cancer