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Pumitamig

Phase 3

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 22, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,600
FDA Designations
No designations recorded
Clinical trial landscape

Pumitamig · 7 trials · 7 indications

Phase 3 2Phase 2 3Phase 1 2
NCT07361497A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)Non-small Cell Lung Cancer (NSCLC)
RECRUITING850 Analytics
NCT07361510A 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)Non-Small Cell Lung Cancer (NSCLC)
RECRUITING750 Analytics
PHASE3RECRUITING
A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
Non-small Cell Lung Cancer (NSCLC)
NCT07361497850
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PHASE3RECRUITING
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)
Non-Small Cell Lung Cancer (NSCLC)
NCT07361510750
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Study Endpoints
Primary Endpoints
Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Up to 3 years
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to approximately 3 years
Overall survival (OS)
Up to approximately 5 years
Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
Up to approximately 4 years
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Up to 2 years after the last participant is randomized

Phase 2

Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR)
Up to approximately 33 months

Phase 3

Number of participants with adverse events (AEs)
Up to approximately 2 years from end of treatment

Phase 1

Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))
Up to approximately 2 years from end of treatment

Phase 1

Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Up to day 21 from first dose

Phase 1

Number of participants with AEs leading to discontinuation
Up to approximately 2 years from end of treatment

Phase 1

Number of participants with AEs leading to death
Up to approximately 2 years from end of treatment

Phase 1

Objective response rate (ORR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment
Up to approximately 2 years from end of treatment

Phase 2

Secondary Endpoints
Overall survival (OS)
Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Up to 3 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm A: PumitamigEXPERIMENTAL -
Arm B: PembrolizumabACTIVE_COMPARATOR -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Arm A1EXPERIMENTAL -
Arm A2EXPERIMENTAL -
Part 1A: Arm AEXPERIMENTAL -
Part 1A: Arm BEXPERIMENTAL -
Part 1B: Arm GEXPERIMENTAL -
Part 1B: Arm HEXPERIMENTAL -
Part 2A: Arm CEXPERIMENTAL -
Part 2A: Arm DEXPERIMENTAL -
Part 2B: Arm IEXPERIMENTAL -
Part 2B: Arm JEXPERIMENTAL -
Part 2C: Arm MEXPERIMENTAL -
Cohort 1AEXPERIMENTAL -
Cohort 1BEXPERIMENTAL -
Cohort 2AEXPERIMENTAL -
Cohort 2BEXPERIMENTAL -
Cohort 2CEXPERIMENTAL -
Cohort 1A2EXPERIMENTAL -
Cohort 1B2EXPERIMENTAL -
Interventions
NameTypeDescription
PumitamigDRUGSpecified dose on specified days
DurvalumabDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
ImzokitugDRUGSpecified dose on specified days
FolfoxDRUGSpecified dose on specified days
CapoxDRUGSpecified dose on specified days
NivolumabDRUGSpecified dose on specified days
FOLFIRIDRUGSpecified dose on specified days
BevacizumabDRUGSpecified dose on specified days
IpilimumabDRUGSpecified dose on specified days
CabozantinibDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites256

Inclusion Criteria * Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease. * Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaFranceGermanyGreeceHong KongHungaryIndiaIrelandItalyJapanMexicoNetherlandsPolandRomaniaSingaporeSouth KoreaSpainSwedenSwitzerlandTaiwanThailandTurkey (Türkiye)United KingdomColombiaCzechiaFinlandMalaysiaNorwayPeruPortugal
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Recent Changes (Last 90 Days)
LOWJul 22, 2026NCT07221357lastUpdatePostDate: changed
LOWJul 22, 2026NCT07221357lastUpdatePostDate: changed
LOWJul 20, 2026NCT07361510lastUpdatePostDate: changed
LOWJul 20, 2026NCT07221149lastUpdatePostDate: changed
LOWJul 20, 2026NCT07361497lastUpdatePostDate: changed
LOWJul 20, 2026NCT07293351lastUpdatePostDate: changed
LOWJul 20, 2026NCT07221149lastUpdatePostDate: changed
LOWJul 20, 2026NCT07361497lastUpdatePostDate: changed
LOWJul 20, 2026NCT07293351lastUpdatePostDate: changed
LOWJul 20, 2026NCT07361510lastUpdatePostDate: changed
LOWJul 2, 2026NCT07680764NEW_TRIAL: changed
LOWJul 2, 2026NCT07680764NEW_TRIAL: changed
LOWJun 26, 2026NCT07291076lastUpdatePostDate: changed
LOWJun 26, 2026NCT07361510lastUpdatePostDate: changed
LOWJun 26, 2026NCT07221149lastUpdatePostDate: changed
LOWJun 26, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 26, 2026NCT07293351lastUpdatePostDate: changed
LOWJun 26, 2026NCT07291076lastUpdatePostDate: changed
LOWJun 26, 2026NCT07361497lastUpdatePostDate: changed
LOWJun 26, 2026NCT07293351lastUpdatePostDate: changed