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)
Recruiting · NCT07361497 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 20 US states.
- Southern Cancer Center Pc - Daphne, Alabama, United States
- Local Institution - 0780 - Chandler, Arizona, United States
- Intermountain Health Cancer Center Lutheran Hospital - Golden, Colorado, United States
- Medical Oncology Hematology Consultants, PA - Newark, Delaware, United States
- Local Institution - 0711 - Ocala, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Marietta, Georgia, United States
- University of Chicago Medical Center - Chicago, Illinois, United States
- Local Institution - 0850 - Evanston, Illinois, United States
- Illinois Cancer Care - Peoria, Illinois, United States
- Fort Wayne Medical Oncology and Hematology - Fort Wayne, Indiana, United States
- University of Kentucky Chandler Medical Center - Lexington, Kentucky, United States
- Local Institution - 0603 - Boston, Massachusetts, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Minnesota Oncology Hematology - Maple Grove, Minnesota, United States
- Local Institution - 0142 - Saint Paul, Minnesota, United States
- Missouri Cancer Associates - Columbia, Missouri, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Local Institution - 0339 - Westbury, New York, United States
- Optum Medical Care, PC - Westbury, New York, United States
- Local Institution - 0493 - Winston-Salem, North Carolina, United States
- Local Institution - 0923 - Akron, Ohio, United States
- The Christ Hospital - Cincinnati, Ohio, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Cleveland Clinic - Hillcrest Hospital - Mayfield Heights, Ohio, United States
- Oncology Associates Of Oregon, Pc - Eugene, Oregon, United States
- Northwest Cancer Specialists, P.C. - Happy Valley, Oregon, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- Texas Oncology - Amarillo Cancer Center - Amarillo, Texas, United States
- Texas Oncology-Austin Central - Austin, Texas, United States
- Texas Oncology - Denton, Texas, United States
- The Center For Cancer And Blood Disorders - Fort Worth, Texas, United States
- The University of Texas-MD Anderson Cancer Center - Houston, Texas, United States
- Texas Oncology - San Antonio Medical Center - San Antonio, Texas, United States
- Texas Oncology - Northeast Texas - Tyler, Texas, United States
- Blue Ridge Cancer Care - Christiansburg, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Local Institution - 0099 - Adana, Turkey (Türkiye)
- Local Institution - 0113 - Adana, Turkey (Türkiye)
- Local Institution - 0198 - Antalya, Turkey (Türkiye)
- Errikos Dunant Hospital Center - Athens, Greece
- Local Institution - 0733 - Bangkok, Thailand
- OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces - Barakaldo, Spain
- Parc de Salut Mar - Hospital del Mar - Barcelona, Spain
- Universitaetsspital Basel - Basel, Switzerland
- Ospedale Regionale Bellinzona e Valli - Bellinzona, Switzerland
- Local Institution - 0217 - Berlin, Germany
- Local Institution - 0215 - Berlin, Germany
- Algemeen Ziekenhuis klina - Brasschaat, Belgium
- Spitalul Universitar de Urgență București - Bucharest, Romania
- Local Institution - 0138 - Budapest, Hungary
- Instituto Medico Especializado Alexander Fleming - Buenos Aires, Argentina
- Clinica Adventista Belgrano - Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires - Buenos Aires, Argentina
- Addenbrooke's Hospital - Cambridge, United Kingdom
- Velindre Cancer Centre - Cardiff, United Kingdom
- Local Institution - 0917 - Chiang Mai, Thailand
- Institutul Oncologic Cluj - Cluj-Napoca, Romania
- Local Institution - 0276 - Cork, Ireland
Showing 60 of 259 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →