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)

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

  • Non-small Cell Lung Cancer (NSCLC)

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