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).

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06646276
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Extensive-Stage Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986489 (BMS-986012+Nivolumab) — BIOLOGICAL
    Specified dose on specified days
  • Atezolizumab — BIOLOGICAL
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Etoposide — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
May 2026
Primary completion
Apr 6, 2028
Completion
Sep 5, 2031

Study Design

Enrollment
530 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

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

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (20)

FacilityCityStateZIPSite coordinators
Southern Cancer Center, PCDaphneAlabama36526
Michael Meshad, Site 0337
111-111-1111
Local Institution - 0283Hot SpringsArkansas71913-
Florida Cancer Specialists - SouthFort MyersFlorida33901
Alexander Glick, Site 0245
239-274-9930
Mid Florida Hematology and Oncology CenterOrange CityFlorida32763
Santosh Nair, Site 0009
407-353-1915
Florida Cancer Specialists - NorthSt. PetersburgFlorida33705
Maen Hussein, Site 0020
727-216-1143
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMariettaGeorgia30060
Walid Shaib, Site 0013
770-281-5124
Illinois Cancer CarePeoriaIllinois61615
Gary MacVicar, Site 0019
309-243-3000
Local Institution - 0037MinneapolisMinnesota55407-
University of New Mexico Comprehensive Cancer CenterAlbuquerqueNew Mexico87106
Moises Harari-Turquie, Site 0033
505-570-5835
Duke Cancer InstituteDurhamNorth Carolina27710
Neal Ready, Site 0029
919-684-8239
Sanford Medical CenterBismarckNorth Dakota58501
Thandiwe Gray, Site 0232
701-323-5741
Sanford Fargo Medical CenterFargoNorth Dakota58102
Mark Gitau, Site 0010
000-000-0000
Oncology Hematology CareCincinnatiOhio45242
Patrick Ward, Site 0284
513-751-2273
Sanford Cancer CenterSioux FallsSouth Dakota57104
Allison Watson, Site 0231
605-209-4092
SCRI Oncology PartnersNashvilleTennessee37203
Melissa Johnson, Site 0008
615-329-7274
Texas Oncology - Central/South TexasAustinTexas78705
James Uyeki, Site 0001
512-427-9400
Texas Oncology - Northeast TexasTylerTexas75702
Sarah Wang, Site 0281
903-579-9800
Oncology & Hematology Associates of Southwest Virginia, Inc.RoanokeVirginia24014
Jerome Goldschmidt, Site 0246
540-381-5291
Swedish Cancer Institute - EdmondsEdmondsWashington98026
Siddhartha Devarakonda, Site 0339
206-386-2457
Swedish Medical CenterSeattleWashington98104
Siddhartha Devarakonda, Site 0026
206-386-2457

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Southern Cancer Center, PC· Daphne, ALLocal Institution - 0283· Hot Springs, ARFlorida Cancer Specialists - South· Fort Myers, FLMid Florida Hematology and Oncology Center· Orange City, FLFlorida Cancer Specialists - North· St. Petersburg, FLNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital· Marietta, GA

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