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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
Active Comparator
Arm B
  • Drug: Durvalumab
    Specified dose on specified days

Recruiting Locations

Southern Cancer Center Pc
Daphne, Alabama 36526
Contact:
Michael Meshad, Site 0898
111-111-1111

Medical Oncology Hematology Consultants, PA
Newark, Delaware 19713
Contact:
Jamal Misleh, Site 0896
302-366-1200

Illinois Cancer Care
Peoria, Illinois 61615
Contact:
Srinivas Jujjavarapu, Site 0897
309-243-3000

Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana 46804
Contact:
Ahad Sadiq, Site 0317
260-436-0800

Minnesota Oncology Hematology
Maple Grove, Minnesota 55369
Contact:
Daniel Mundt, Site 0322

Missouri Cancer Associates
Columbia, Missouri 65201
Contact:
Caleb Smith, Site 0900

Memorial Sloan Kettering Cancer Center
New York, New York 10065
Contact:
Mark Awad, Site 0606

Oncology Associates Of Oregon, Pc
Eugene, Oregon 97401
Contact:
Bo Wang, Site 0895
541-683-5001

Northwest Cancer Specialists, P.C.
Happy Valley, Oregon 97015
Contact:
Anthony Van Ho, Site 0302
503-885-5411

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Melissa Johnson, Site 0240
615-329-7274

Tennessee Oncology
Nashville, Tennessee 37203
Contact:
Wade Iams, Site 0480
615-322-4967

Texas Oncology - Amarillo Cancer Center
Amarillo, Texas 79124
Contact:
Pankaj Khandelwal, Site 0908
000-000-0000

Texas Oncology-Austin Central
Austin, Texas 78731
Contact:
James Uyeki, Site 0857
512-427-9400

Texas Oncology
Denton, Texas 76210
Contact:
Kartik Konduri, Site 0894
214-370-1000

The University of Texas-MD Anderson Cancer Center
Houston, Texas 77030
Contact:
Tina Cascone, Site 0596
713-792-6363

Texas Oncology - San Antonio Medical Center
San Antonio, Texas 78229
Contact:
Krishna Alluri, Site 0902
210-656-7177

Texas Oncology - Northeast Texas
Tyler, Texas 75702
Contact:
Sarah Wang, Site 0899
903-579-9800

Blue Ridge Cancer Care
Christiansburg, Virginia 24073
Contact:
Jerome Goldschmidt, Site 0133
540-381-5291

Virginia Oncology Associates
Norfolk, Virginia 23502
Contact:
John Paschold, Site 0250

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.