Clinical Trials in France / 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 France tracker
Condition(s) studied
Non-small Cell Lung Cancer (NSCLC)
Investigational drug(s) / intervention(s)
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
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)
- Progression-free survival (PFS) by blinded independent central review (BICR) (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) — Up to 3 years
Trial sites (260)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center Pc | Daphne | Alabama | 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 |
| Local Institution - 0935 | Plantation | 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 |
| Endeavor Health | Evanston | Illinois | 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 |
| Allina Health Cancer Institute - Abbott Northwestern Hospital | Minneapolis | Minnesota | 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 |
| Novant Health Pharmacy Oncology Specialists | Winston-Salem | North Carolina | Recruiting |
| Akron General Medical Center | Akron | Ohio | 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 |
| Investigaciones Oncologicas C Colon SA | Mar del Plata | Buenos Aires | Recruiting |
+ 220 more sites — see the full list on the official registry below.
On this site
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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 France