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Pumitamig

Phase 3

Non-Small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 28, 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)Unlock trial analytics
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)Unlock trial analytics

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: 1A-1 Pumitamig + IpilimumabEXPERIMENTAL -
Part 1A: 1A-2 Pumitamig + IpilimumabEXPERIMENTAL -
Part 1B: 1B-1 Pumitamig + CabozantinibEXPERIMENTAL -
Part 1B: 1B-2 Pumitamig + CabozantinibEXPERIMENTAL -
Part 2A: 2A-1 Pumitamig + IpilimumabEXPERIMENTAL -
Part 2A: 2A-2 Pumitamig + IpilimumabEXPERIMENTAL -
Part 2B: 2B-1 Pumitamig + CabozantinibEXPERIMENTAL -
Part 2B: 2B-2 Pumitamig + CabozantinibEXPERIMENTAL -
Part 2C: 2C-1 PumitamigEXPERIMENTAL -
Part 2D: 2D-1 Pumitamig + CasdatifanEXPERIMENTAL -
Part 2E: 2E-1 Pumitamig + Ipilimumab + CasdatifanEXPERIMENTAL -
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
CasdatifanDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites258

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)

MEDIUMAug 28, 2026NCT07293351Enrollment: 254 → 474
MEDIUMAug 28, 2026NCT07293351Enrollment: 254 → 474
LOWAug 19, 2026NCT07291076lastUpdatePostDate: changed
LOWAug 19, 2026NCT07291076lastUpdatePostDate: changed
LOWAug 19, 2026NCT07291076lastUpdatePostDate: changed
LOWAug 17, 2026NCT07221357lastUpdatePostDate: changed
LOWAug 17, 2026NCT07221357lastUpdatePostDate: changed
LOWAug 12, 2026NCT07221149lastUpdatePostDate: changed
LOWAug 12, 2026NCT07221149lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361510lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361497lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361497lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361510lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361497lastUpdatePostDate: changed
LOWAug 11, 2026NCT07361510lastUpdatePostDate: changed
LOWJul 30, 2026NCT07293351lastUpdatePostDate: changed
LOWJul 30, 2026NCT07293351lastUpdatePostDate: changed
LOWJul 24, 2026NCT07680764Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 24, 2026NCT07291076lastUpdatePostDate: changed
LOWJul 24, 2026NCT07680764Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Pumitamig

What is Pumitamig used for?

Pumitamig is an investigational oncology drug being studied for untreated, unresectable, or metastatic colorectal cancer, advanced renal cell carcinoma (RCC), locally advanced non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), and untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. It is in Phase 1 and Phase 2 clinical trials.

Who makes Pumitamig?

Pumitamig is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting multiple clinical trials evaluating the drug in various solid tumor indications.

What phase is Pumitamig in?

Pumitamig is in Phase 1 and Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Active trials are recruiting participants for studies in colorectal cancer, hepatocellular carcinoma, renal cell carcinoma, and non-small cell lung cancer.

What clinical trials is Pumitamig in?

Pumitamig is being studied in several recruiting trials. NCT07221357 evaluates it with chemotherapy versus bevacizumab with chemotherapy in colorectal cancer. NCT07291076 tests it alone or with ipilimumab in HCC. NCT07293351 assesses it alone or with other agents in RCC. NCT07680764 studies it with imzokitug and chemotherapy in NSCLC.

How does Pumitamig work?

Pumitamig is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available clinical trial information. The ongoing studies are designed to evaluate its safety, tolerability, and efficacy in combination with other anticancer agents across multiple solid tumor types.

Is Pumitamig being studied in combination with other drugs?

Yes, Pumitamig is being evaluated both alone and in combination with other agents. Trials include combinations with chemotherapy, ipilimumab, and imzokitug. These studies are investigating its use in first-line and advanced settings for various solid tumors including colorectal cancer, HCC, RCC, and NSCLC.