RecruitingInterventionalPhase 3

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.

NCT ID: NCT07361497Sponsor: Bristol-Myers SquibbLast updated: 2026-06-03

Summary

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

Arms & interventions

DrugPumitamig
Specified dose on specified days
DrugDurvalumab
Specified dose on specified days

Outcome measures

Primary

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

Secondary

Overall survival (OS)
Time frame: Up to approximately 9 years
PFS by investigator (per RECIST v1.1)
Time frame: Up to 3 years
Objective response (OR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Disease control rate (DCR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Duration of response (DOR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years
Time to Response (TTR) by BICR (per RECIST v1.1)
Time frame: Up to 3 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (38)

Southern Cancer Center Pc

Daphne, Alabama, 36526

Recruiting

Michael Meshad, Site 0898 · Contact

111-111-1111

Local Institution - 0780

Chandler, Arizona, 85224

Not Yet Recruiting

Site 0780 · Contact

Local Institution - 0585

Golden, Colorado, 80401

Not Yet Recruiting

Site 0585 · Contact

Medical Oncology Hematology Consultants, PA

Newark, Delaware, 19713

Recruiting

Jamal Misleh, Site 0896 · Contact

302-366-1200

Local Institution - 0711

Ocala, Florida, 34474

Not Yet Recruiting

Site 0711 · Contact

Local Institution - 0756

Marietta, Georgia, 30060

Not Yet Recruiting

Site 0756 · Contact

Local Institution - 0398

Chicago, Illinois, 60637

Not Yet Recruiting

Site 0398 · Contact

Local Institution - 0850

Evanston, Illinois, 60201

Not Yet Recruiting

Site 0850 · Contact

Illinois Cancer Care

Peoria, Illinois, 61615

Recruiting

Srinivas Jujjavarapu, Site 0897 · Contact

309-243-3000

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, 46804

Recruiting

Ahad Sadiq, Site 0317 · Contact

260-436-0800

Local Institution - 0656

Lexington, Kentucky, 40536-0284

Not Yet Recruiting

Site 0656 · Contact

Local Institution - 0603

Boston, Massachusetts, 02114-2621

Not Yet Recruiting

Site 0603 · Contact

Local Institution - 0419

Detroit, Michigan, 48201

Not Yet Recruiting

Site 0419 · Contact

Minnesota Oncology Hematology

Maple Grove, Minnesota, 55369

Recruiting

Daniel Mundt, Site 0322 · Contact

Local Institution - 0142

Saint Paul, Minnesota, 55102

Not Yet Recruiting

Site 0142 · Contact

Missouri Cancer Associates

Columbia, Missouri, 65201

Recruiting

Caleb Smith, Site 0900 · Contact

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

Mark Awad, Site 0606 · Contact

Local Institution - 0339

Westbury, New York, 11590

Withdrawn

Local Institution - 0909

Westbury, New York, 11590

Not Yet Recruiting

Site 0909 · Contact

Local Institution - 0493

Winston-Salem, North Carolina, 27103

Not Yet Recruiting

Site 0493 · Contact

Local Institution - 0923

Akron, Ohio, 44302

Not Yet Recruiting

Site 0923 · Contact

Local Institution - 0412

Cincinnati, Ohio, 45219

Not Yet Recruiting

Site 0412 · Contact

Local Institution - 0359

Cleveland, Ohio, 44106-5066

Not Yet Recruiting

Site 0359 · Contact

Local Institution - 0597

Cleveland, Ohio, 44195

Not Yet Recruiting

Site 0597 · Contact

Local Institution - 0924

Mayfield Heights, Ohio, 44124

Not Yet Recruiting

Site 0924 · Contact

Oncology Associates Of Oregon, Pc

Eugene, Oregon, 97401

Recruiting

Bo Wang, Site 0895 · Contact

541-683-5001

Northwest Cancer Specialists, P.C.

Happy Valley, Oregon, 97015

Recruiting

Anthony Van Ho, Site 0302 · Contact

503-885-5411

Local Institution - 0480

Nashville, Tennessee, 37203

Not Yet Recruiting

Site 0480 · Contact

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

Melissa Johnson, Site 0240 · Contact

615-329-7274

Texas Oncology - Amarillo Cancer Center

Amarillo, Texas, 79124

Recruiting

Pankaj Khandelwal, Site 0908 · Contact

000-000-0000

Texas Oncology-Austin Central

Austin, Texas, 78731

Recruiting

James Uyeki, Site 0857 · Contact

512-427-9400

Texas Oncology

Denton, Texas, 76210

Recruiting

Kartik Konduri, Site 0894 · Contact

214-370-1000

Local Institution - 0811

Fort Worth, Texas, 76104

Not Yet Recruiting

Site 0811 · Contact

Local Institution - 0596

Houston, Texas, 77030

Not Yet Recruiting

Site 0596 · Contact

Texas Oncology - San Antonio Medical Center

San Antonio, Texas, 78229

Recruiting

Krishna Alluri, Site 0902 · Contact

210-656-7177

Texas Oncology - Northeast Texas

Tyler, Texas, 75702

Recruiting

Sarah Wang, Site 0899 · Contact

903-579-9800

Blue Ridge Cancer Care

Christiansburg, Virginia, 24073

Recruiting

Jerome Goldschmidt, Site 0133 · Contact

540-381-5291

Virginia Oncology Associates

Norfolk, Virginia, 23502

Recruiting

John Paschold, Site 0250 · Contact