A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)
Recruiting · NCT07361510 · 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
The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.
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 diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB/IIIC or Stage IV disease.
- Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.
- Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
- Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Exclusion criteria
- Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.
- Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.
- Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.
- Participants must not an active autoimmune disease.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 19 US states.
- Southern Cancer Center Pc - Daphne, Alabama, United States
- Mohtaseb Cancer Center & Blood Disorders - Bullhead City, Arizona, United States
- Palo Verde Hematology Oncology - Glendale, Arizona, United States
- Beverly Hills Cancer Center - Beverly Hills, California, United States
- Orange Coast Memorial Medical Center - Fountain Valley, California, United States
- Local Institution - 0027 - Los Alamitos, California, United States
- Local Institution - 0422 - Los Angeles, California, United States
- Pacific Cancer Care - Monterey, California, United States
- Local Institution - 0403 - Oakland, California, United States
- Local Institution - 0208 - Pleasant Hill, California, United States
- BASS Cancer Center - Walnut Creek, California, United States
- Local Institution - 0340 - Lakewood, Colorado, United States
- Clermont Oncology Center - Clermont, Florida, United States
- Advanced Research - Coral Springs, Florida, United States
- BRP- Hialeah Hospital - Hialeah, Florida, United States
- Florida Clinical Trials Group - Tamarac, Florida, United States
- University Cancer & Blood Center, LLC - Athens, Georgia, United States
- Local Institution - 0412 - Augusta, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Marietta, Georgia, United States
- Local Institution - 0423 - Urbana, Illinois, United States
- Northwest Cancer Centers, P.C. - Dyer, Indiana, United States
- Missouri Cancer Associates - Columbia, Missouri, United States
- Local Institution - 0224 - Laurelton, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Optum Medical Care, PC - Westbury, New York, United States
- Novant Health Pharmacy Oncology Specialists - Winston-Salem, North Carolina, United States
- Local Institution - 0383 - Cincinnati, Ohio, United States
- Local Institution - 0418 - Oklahoma City, Oklahoma, United States
- Lancaster General Hospital - Lancaster, Pennsylvania, United States
- Local Institution - 0028 - Pittsburgh, Pennsylvania, United States
- WellSpan Oncology Research - York, Pennsylvania, United States
- University Of Texas Medical Branch At Galveston - Galveston, Texas, United States
- Kelsey-Seybold Clinic Main Campus - Houston, Texas, United States
- Texas Oncology - San Antonio - San Antonio, Texas, United States
- Local Institution - 0381 - San Antonio, Texas, United States
- Local Institution - 0337 - Richmond, Virginia, United States
- Shenandoah Oncology, P.C. - Winchester, Virginia, United States
- Local Institution - 0384 - Spokane, Washington, United States
- Charleston Area Medical Center (CAMC) - Charleston, West Virginia, United States
- HSHS St. Vincent Hospital Regional Cancer Center - Green Bay, Wisconsin, United States
- Local Institution - 0421 - Marshfield, Wisconsin, United States
- Local Institution - 0100 - 's-Hertogenbosch, Netherlands
- Local Institution - 0242 - Adana, Turkey (Türkiye)
- Local Institution - 0091 - Adana, Turkey (Türkiye)
- Meander Medisch Centrum - Amersfoort, Netherlands
- Local Institution - 0415 - Ankara, Turkey (Türkiye)
- Local Institution - 0118 - Antalya, Turkey (Türkiye)
- Aomori Prefectural Central Hospital - Aomori, Japan
- Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu - Baloteşti, Romania
- Local Institution - 0272 - Bangkok, Thailand
- Local Institution - 0113 - Beijing, China
- Local Institution - 0231 - Berlin, Germany
- Local Institution - 0218 - Bogotá, Colombia
- Unidade Local de Saúde de Braga - Braga, Portugal
- Algemeen Ziekenhuis klina - Brasschaat, Belgium
- Local Institution - 0158 - Braunschweig, Germany
- Spitalul Clinic Colțea - Bucharest, Romania
- Spitalul Universitar de Urgență București - Bucharest, Romania
- Local Institution - 0240 - Budapest, Hungary
- Clinica Adventista Belgrano - Buenos Aires, Argentina
Showing 60 of 279 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →