A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)

Part of paid clinical trials in Daphne, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07361510
Phase
PHASE3
Status
Recruiting
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Conditions

  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • Pumitamig — DRUG
    Specified dose on specified days
  • Pembrolizumab — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.

Key Dates

Start date
Mar 12, 2026
Status verified
Jun 2026
Primary completion
Oct 14, 2031
Completion
Oct 14, 2031

Study Design

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

Arms

  • Experimental: Arm A: Pumitamig
  • Active Comparator: Arm B: Pembrolizumab

Primary Outcome Measure

Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to approximately 3 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 (40)

FacilityCityStateZIPSite coordinators
Southern Cancer Center PcDaphneAlabama36526
Michael Meshad, Site 0348
111-111-1111
Local Institution - 0424Bullhead CityArizona86442
Site 0424
Local Institution - 0391GlendaleArizona85304
Site 0391
Local Institution - 0407AnaheimCalifornia92801
Site 0407
Local Institution - 0352Beverly HillsCalifornia90211
Site 0352
Orange Coast Memorial Medical CenterFountain ValleyCalifornia92708
Amol Rao, Site 0299
510673-1293
Local Institution - 0027Los AlamitosCalifornia90720
Site 0027
Local Institution - 0422Los AngelesCalifornia90095
Site 0422
Local Institution - 0403OaklandCalifornia94611
Site 0403
Local Institution - 0208Pleasant HillCalifornia94523
Site 0208
Local Institution - 0416Walnut CreekCalifornia94598
Site 0416
Local Institution - 0340LakewoodColorado80401
Site 0340
Clermont Oncology CenterClermontFlorida34711
Gopal Kunta, Site 0192
352-242-1366
Advanced ResearchCoral SpringsFlorida33321
Sumit Sawhney, Site 0406
954-302-3120
BRP- Hialeah HospitalHialeahFlorida33013
Luis Rangel, Site 0395
833-489-4968
University Cancer & Blood Center, LLCAthensGeorgia30607
Frederick Flynt Jr, Site 0396
706-353-2990
Local Institution - 0412AugustaGeorgia30912
Site 0412
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb HospitalMariettaGeorgia30060
Walid Shaib, Site 0284
770-281-5124
Local Institution - 0423UrbanaIllinois61801
Site 0423
Northwest Cancer Centers, P.C.DyerIndiana46311
Shruti Singh, Site 0409
219-924-8178
Missouri Cancer AssociatesColumbiaMissouri65201
Caleb Smith, Site 0350
Local Institution - 0224LaureltonNew York11413
Site 0224
Local Institution - 0026New YorkNew York10065
Site 0026
Local Institution - 0214WestburyNew York11590
Site 0214
Local Institution - 0283Winston-SalemNorth Carolina27103
Site 0283
Local Institution - 0383CincinnatiOhio45220
Site 0383
Local Institution - 0418Oklahoma CityOklahoma73109
Site 0418
Local Institution - 0288LancasterPennsylvania17601
Site 0288
Local Institution - 0028PittsburghPennsylvania15212
Site 0028
WellSpan Oncology ResearchYorkPennsylvania17403
Ikechukwu Akunyili, Site 0344
717-339-2560
Local Institution - 0376GalvestonTexas77555
Site 0376
Kelsey-Seybold Clinic Main CampusHoustonTexas77025
Sunil Patel, Site 0353
713-442-1700
Local Institution - 0381San AntonioTexas78260
Site 0381
Texas Oncology - San AntonioSan AntonioTexas78217
Krishna Alluri, Site 0351
210-656-7177
Local Institution - 0337RichmondVirginia23298
Site 0337
Shenandoah Oncology, P.C.WinchesterVirginia22601
Michael McCusker Jr., Site 0349
Local Institution - 0384SpokaneWashington99218
Site 0384
Local Institution - 0339CharlestonWest Virginia25304
Site 0339
Local Institution - 0380Green BayWisconsin54301
Site 0380
Local Institution - 0421MarshfieldWisconsin54449
Site 0421

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Southern Cancer Center Pc· Daphne, ALLocal Institution - 0424· Bullhead City, AZLocal Institution - 0391· Glendale, AZLocal Institution - 0407· Anaheim, CALocal Institution - 0352· Beverly Hills, CAOrange Coast Memorial Medical Center· Fountain Valley, CA

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