Recruiting

Phase 3

BMS-986489 & AtezolizumabA 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).

Sponsor:

Bristol-Myers Squibb

Code:

NCT06646276

Conditions

Extensive-Stage Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986489 (BMS-986012+Nivolumab)

Atezolizumab

Carboplatin

Etoposide

Study Details

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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Study ID

NCT06646276

Start date

Feb 25, 2025

Status verified date

Aug, 2026

Completion date

Sep 5, 2031

Anticipated

Primary completion date

Apr 6, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

530 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

active comparator: Arm B

Interventions

BMS-986489 (BMS-986012+Nivolumab)

Specified dose on specified days

Atezolizumab

Specified dose on specified days

Carboplatin

Specified dose on specified days

Etoposide

Specified dose on specified days

Primary outcome measure

Overall Survival (OS) [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286 Clinical.Trials@bms.com

Locations

Southern Cancer Center, PC

Recruiting

Daphne, Alabama, United States, 36526

Contacts

Michael Meshad, Site 0337

111-111-1111

Florida Cancer Specialists - South

Recruiting

Fort Myers, Florida, United States, 33901

Contacts

Alexander Glick, Site 0245

239-274-9930

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Contacts

Santosh Nair, Site 0009

407-353-1915

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33705

Contacts

Maen Hussein, Site 0020

727-216-1143

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Walid Shaib, Site 0013

770-281-5124

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Gary MacVicar, Site 0019

309-243-3000

University of New Mexico Comprehensive Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Moises Harari-Turquie, Site 0033

505-570-5835

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Neal Ready, Site 0029

919-684-8239

Sanford Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Thandiwe Gray, Site 0232

701-323-5741

Sanford Fargo Medical Center

Recruiting

Fargo, North Dakota, United States, 58102

Contacts

Mark Gitau, Site 0010

000-000-0000

Oncology Hematology Care

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Patrick Ward, Site 0284

513-751-2273

Sanford Cancer Center

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Allison Watson, Site 0231

605-209-4092

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Johnson, Site 0008

615-329-7274

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Contacts

James Uyeki, Site 0001

512-427-9400

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Contacts

Sarah Wang, Site 0281

903-579-9800

Oncology & Hematology Associates of Southwest Virginia, Inc.

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Jerome Goldschmidt, Site 0246

540-381-5291

Swedish Cancer Institute - Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Siddhartha Devarakonda, Site 0339

206-386-2457

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98104

Contacts

Siddhartha Devarakonda, Site 0026

206-386-2457

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-31.