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).

Purpose

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.

Condition

  • Extensive-Stage Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Biological: BMS-986489 (BMS-986012+Nivolumab)
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Etoposide
    Specified dose on specified days
Active Comparator
Arm B
  • Biological: Atezolizumab
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days
  • Drug: Etoposide
    Specified dose on specified days

Recruiting Locations

Southern Cancer Center, PC
Daphne 4058219, Alabama 4829764 36526
Contact:
Michael Meshad, Site 0337
111-111-1111

Florida Cancer Specialists - South
Fort Myers 4155995, Florida 4155751 33901
Contact:
Alexander Glick, Site 0245
239-274-9930

Mid Florida Hematology and Oncology Center
Orange City 4167055, Florida 4155751 32763
Contact:
Santosh Nair, Site 0009
407-353-1915

Florida Cancer Specialists - North
St. Petersburg 4171563, Florida 4155751 33705
Contact:
Maen Hussein, Site 0020
727-216-1143

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta 4207783, Georgia 4197000 30060
Contact:
Walid Shaib, Site 0013
770-281-5124

Illinois Cancer Care
Peoria 4905687, Illinois 4896861 61615
Contact:
Gary MacVicar, Site 0019
309-243-3000

University of New Mexico Comprehensive Cancer Center
Albuquerque 5454711, New Mexico 5481136 87106
Contact:
Moises Harari-Turquie, Site 0033
505-570-5835

Duke Cancer Institute
Durham 4464368, North Carolina 4482348 27710
Contact:
Neal Ready, Site 0029
919-684-8239

Oncology Hematology Care
Cincinnati 4508722, Ohio 5165418 45242
Contact:
Patrick Ward, Site 0284
513-751-2273

Sanford Cancer Center
Sioux Falls 5231851, South Dakota 5769223 57104
Contact:
Allison Watson, Site 0231
605-209-4092

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Contact:
Melissa Johnson, Site 0008
615-329-7274

Texas Oncology - Central/South Texas
Austin 4671654, Texas 4736286 78705
Contact:
James Uyeki, Site 0001
512-427-9400

Texas Oncology - Northeast Texas
Tyler 4738214, Texas 4736286 75702
Contact:
Sarah Wang, Site 0281
903-579-9800

Oncology & Hematology Associates of Southwest Virginia, Inc.
Roanoke 4782167, Virginia 6254928 24014
Contact:
Jerome Goldschmidt, Site 0246
540-381-5291

Swedish Cancer Institute - Edmonds
Edmonds 5793427, Washington 5815135 98026
Contact:
Siddhartha Devarakonda, Site 0339
206-386-2457

Swedish Medical Center
Seattle 5809844, Washington 5815135 98104
Contact:
Siddhartha Devarakonda, Site 0026
206-386-2457

More Details

NCT ID
NCT06646276
Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicaltrials.com
855-907-3286
Clinical.Trials@BMS.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center