A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07063745
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Eligibility Criteria

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

Interventions

  • BMS-986504 — DRUG
    Specified dose on specified days
  • Pembrolizumab — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Paclitaxel — DRUG
    Specified dose on specified days
  • Nab-paclitaxel — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

Key Dates

Start date
Jan 2, 2026
Status verified
Jun 2026
Primary completion
Aug 12, 2031
Completion
Aug 12, 2031

Study Design

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

Arms

  • Active Comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy
  • Active Comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy
  • Placebo Comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy
  • Placebo Comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy
  • Active Comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy
  • Placebo Comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy

Primary Outcome Measure

Progression-free survival (PFS) by RECIST v1.1 [ Time Frame: Up to 2 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 (42)

FacilityCityStateZIPSite coordinators
Alaska Oncology and HematologyAnchorageAlaska99508
Steven Liu, Site 0119
907-257-9851
Mayo Clinic in Arizona - PhoenixPhoenixArizona85054
Vinicius Ernani, Site 0388
480-342-4800
University of Arizona Cancer CenterTucsonArizona85724
Ricklie Julian, Site 0120
850-557-2723
Highlands Oncology GroupSpringdaleArkansas72762
Eric Schaefer, Site 0135
479-872-8130
Local Institution - 0497Los AlamitosCalifornia90720
Site 0497
Local Institution - 0444Los AngelesCalifornia90067-
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Robert Hsu, Site 0407
323-865-3000
Local Institution - 0606NewarkDelaware19713
Site 0606
Helios Clinical Research - Fort LauderdaleFort LauderdaleFlorida33316
Edgardo Santos, Site 0152
239-938-9315
Mayo Clinic in FloridaJacksonvilleFlorida32224
Shenduo Li, Site 0389
904-953-0315
Local Institution - 0430St. PetersburgFlorida33709-
St. Luke's Cancer Institute: BoiseBoiseIdaho83712
Sri Harsha Tella, Site 0124
Local Institution - 0605DecaturIllinois62526
Site 0605
Baptist Health LexingtonLexingtonKentucky40503
Firas Badin, Site 0333
859-260-6100
University of Kentucky Chandler Medical CenterLexingtonKentucky40536
John Villano, Site 0125
859-323-6522
Local Institution - 0127ScarboroughMaine04074
Site 0127
Dana-Farber Cancer InstituteBostonMassachusetts02215
Pasi Janne, Site 0158
617-632-6036
Local Institution - 0418Ann ArborMichigan48109
Site 0418
Local Institution - 0405DetroitMichigan48201
Site 0405
Local Institution - 0420Traverse CityMichigan49684
Site 0420
Mayo Clinic in Rochester, MinnesotaRochesterMinnesota55905
Konstantinos Leventakos, Site 0182
507-284-2511
Oncology Hematology West P.C. dba Nebraska Cancer SpecialistsOmahaNebraska68130
Geetha Palaniappan, Site 0160
402-593-3141
Local Institution - 0467LebanonNew Hampshire03756
Site 0467
Local Institution - 0600ManchesterNew Hampshire03103
Site 0600
WMCHealth Advanced Physician ServicesHawthorneNew York10532
Marjorie Zauderer, Site 0179
914-493-8375
Local Institution - 0128RochesterNew York14642
Site 0128
Local Institution - 0518SchenectadyNew York12308
Site 0518
Local Institution - 0514Winston-SalemNorth Carolina27157
Site 0514
Local Institution - 0163ClevelandOhio44195-
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Timothy Burns, Site 0129
412-864-7859
Kaiser Permanente Interstate Medical Office CentralPortlandOregon97227
Sandeep Mashru, Site 0348
503-249-3315
Providence Portland Medical CenterPortlandOregon97213
Rachel Sanborn, Site 0164
503-215-5696
Local Institution - 0608GreenvilleSouth Carolina29607
Site 0608
Local Institution - 0515KnoxvilleTennessee37920
Site 0515
Local Institution - 0433DallasTexas75390
Site 0433
Renovatio Clinical - El PasoEl PasoTexas79915
Mary Crow, Site 0374
713-703-2398
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Natalie Vokes, Site 0132
000-000-0000
Local Institution - 0377The WoodlandsTexas77380-
Huntsman Cancer InstituteSalt Lake CityUtah84112
Matthew Gumbleton, Site 0354
801-587-4557
Local Institution - 0131FairfaxVirginia22031-
Virginia Commonwealth UniversityRichmondVirginia23219
Renato Martins, Site 0186
804-828-7999
Fred Hutchinson Cancer CenterSeattleWashington98109
Lei Deng, Site 0145
206-606-4801

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Alaska Oncology and Hematology· Anchorage, AKMayo Clinic in Arizona - Phoenix· Phoenix, AZUniversity of Arizona Cancer Center· Tucson, AZHighlands Oncology Group· Springdale, ARLocal Institution - 0497· Los Alamitos, CALocal Institution - 0444· Los Angeles, CA