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Clinical Trials in India / NCT07361497
Recruiting Phase 3

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)

NCT07361497 · tracked via the Priya Life Science India tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2026-03-16
Last updated
2026-09-08

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

PumitamigDurvalumab

Pumitamig: Specified dose on specified days

Durvalumab: Specified dose on specified days

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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.

Primary outcome measure(s)

Trial sites (259)

FacilityCityRegionStatus
Southern Cancer Center Pc Daphne Alabama Recruiting
Local Institution - 0780 Chandler Arizona Not Yet Recruiting
Intermountain Health Cancer Center Lutheran Hospital Golden Colorado Recruiting
Medical Oncology Hematology Consultants, PA Newark Delaware Recruiting
Local Institution - 0711 Ocala Florida Not Yet Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
Local Institution - 0850 Evanston Illinois Not Yet Recruiting
Illinois Cancer Care Peoria Illinois Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Recruiting
Local Institution - 0603 Boston Massachusetts Not Yet Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Minnesota Oncology Hematology Maple Grove Minnesota Recruiting
Local Institution - 0142 Saint Paul Minnesota Not Yet Recruiting
Missouri Cancer Associates Columbia Missouri Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Local Institution - 0339 Westbury New York Withdrawn
Optum Medical Care, PC Westbury New York Recruiting
Local Institution - 0493 Winston-Salem North Carolina Not Yet Recruiting
Local Institution - 0923 Akron Ohio Not Yet Recruiting
The Christ Hospital Cincinnati Ohio Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
Cleveland Clinic - Hillcrest Hospital Mayfield Heights Ohio Recruiting
Oncology Associates Of Oregon, Pc Eugene Oregon Recruiting
Northwest Cancer Specialists, P.C. Happy Valley Oregon Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
Texas Oncology - Amarillo Cancer Center Amarillo Texas Recruiting
Texas Oncology-Austin Central Austin Texas Recruiting
Texas Oncology Denton Texas Recruiting
The Center For Cancer And Blood Disorders Fort Worth Texas Recruiting
The University of Texas-MD Anderson Cancer Center Houston Texas Recruiting
Texas Oncology - San Antonio Medical Center San Antonio Texas Recruiting
Texas Oncology - Northeast Texas Tyler Texas Recruiting
Blue Ridge Cancer Care Christiansburg Virginia Recruiting
Virginia Oncology Associates Norfolk Virginia Recruiting
Instituto Argentino De Diagnostico Y Tratamiento IADT Buenas Aires Buenos Aires Recruiting
Local Institution - 0082 Mar del Plata Buenos Aires Not Yet Recruiting

+ 219 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

More Bristol-Myers Squibb trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07361497 on ClinicalTrials.gov ↗ ← All trials in India