Recruiting
Phase 3

Pumitamig vs. Durvalumab

Sponsor:

Bristol-Myers Squibb

Code:

NCT07361497

Conditions

Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pumitamig

Durvalumab

Study Details

Brief summary:

A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study ID

NCT07361497

Start date

Mar 16, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Sep 18, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 of at least 54 Gy).
  • Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.

Exclusion Criteria

  • Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.
  • Participants must not have an active autoimmune disease.
  • Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.
  • Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.
  • Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

active comparator: Arm B

Interventions

Pumitamig

Specified dose on specified days

Durvalumab

Specified dose on specified days

Primary outcome measure

  • Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Southern Cancer Center Pc

Recruiting

Daphne, Alabama, United States, 36526

Contacts

Michael Meshad, Site 0898

111-111-1111

Intermountain Health Cancer Center Lutheran Hospital

Recruiting

Golden, Colorado, United States, 80401

Contacts

Karng Log, Site 0585

303-403-7333

Medical Oncology Hematology Consultants, PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Jamal Misleh, Site 0896

302-366-1200

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Walid Shaib, Site 0756

770-281-5124

Illinois Cancer Care

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Srinivas Jujjavarapu, Site 0897

309-243-3000

Fort Wayne Medical Oncology and Hematology

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Ahad Sadiq, Site 0317

260-436-0800

University of Kentucky Chandler Medical Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Zhonglin Hao, Site 0656

859-218-6704

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Minnesota Oncology Hematology

Recruiting

Maple Grove, Minnesota, United States, 55369

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Optum Medical Care, PC

Recruiting

Westbury, New York, United States, 11590

Contacts

Jonathan Goldberg, Site 0909

914-242-2991

Oncology Associates Of Oregon, Pc

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Bo Wang, Site 0895

541-683-5001

Northwest Cancer Specialists, P.C.

Recruiting

Happy Valley, Oregon, United States, 97015

Contacts

Anthony Van Ho, Site 0302

503-885-5411

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Melissa Johnson, Site 0240

615-329-7274

Tennessee Oncology

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Wade Iams, Site 0480

615-322-4967

Texas Oncology - Amarillo Cancer Center

Recruiting

Amarillo, Texas, United States, 79124

Contacts

Pankaj Khandelwal, Site 0908

000-000-0000

Texas Oncology-Austin Central

Recruiting

Austin, Texas, United States, 78731

Contacts

James Uyeki, Site 0857

512-427-9400

Texas Oncology

Recruiting

Denton, Texas, United States, 76210

Contacts

Kartik Konduri, Site 0894

214-370-1000

The Center For Cancer And Blood Disorders

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Ray Page, Site 0811

817-759-7000

The University of Texas-MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Tina Cascone, Site 0596

713-792-6363

Texas Oncology - San Antonio Medical Center

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Krishna Alluri, Site 0902

210-656-7177

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Contacts

Sarah Wang, Site 0899

903-579-9800

Blue Ridge Cancer Care

Recruiting

Christiansburg, Virginia, United States, 24073

Contacts

Jerome Goldschmidt, Site 0133

540-381-5291

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Paul Wheatley-Price, Site 0337

613737770070175

St. Marys Hospital Center

Recruiting

Montreal, Quebec, Canada, H3T 1M5

Contacts

Adrian Langleben, Site 0644

514-345-3511-3793

IUCPQ

Recruiting

Québec, Canada, G1V 4G5

Contacts

Maude Dubé-Pelletier, Site 0682

418-656-8711

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Pumitamig
  • Locally advanced
  • Unresectable
  • Stage 3 Non-small Cell Lung Cancer (NSCLC)
  • CA2660001

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-10.