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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)
Sponsor: Bristol-Myers Squibb
Summary
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%.
Official title: ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
750
Start Date
2026-03-12
Completion Date
2031-10-14
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Pumitamig
Specified dose on specified days
Pembrolizumab
Specified dose on specified days
Locations (283)
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
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
UCLA
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
Cincinnati Veterans Affairs Medical Center
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
Marshfield Medical Center - Marshfield
Marshfield, Wisconsin, United States
Investigaciones Oncologicas C Colon SA
Mar del Plata, Buenos Aires, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Sanatorio Plaza
Rosario, Santa Fe Province, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina
Clinica Adventista Belgrano
Buenos Aires, Argentina
Hospital Italiano De Cordoba
Córdoba, Argentina
Gosford Hospital
Gosford, New South Wales, Australia
Nepean Hospital
Penrith, New South Wales, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia
Grampians Health
Ballarat Central, Victoria, Australia
Local Institution - 0201
Epping, Victoria, Australia
Joondalup Health Campus
Joondalup, Western Australia, Australia
Kepler Universitaetsklinikum
Linz, Upper Austria, Austria
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Universitätsklinikum St. Pölten
Sankt Pölten, Austria
ZAS Augustinus
Wilrijk, Antwerpen, Belgium
CHIREC - site delta
Auderghem, Bruxelles-Capitale, Région de, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Algemeen Ziekenhuis klina
Brasschaat, Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital São Lucas da PUCRS - Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
A. C. Camargo Cancer Center
São Paulo, São Paulo, Brazil
Instituto do Cancer Brasil - Taubate
Taubaté, São Paulo, Brazil
Centro Paulista de Oncologia Clínica
São Paulo, Brazil
Complex Oncology Center - Ruse EOOD
Rousse, Bulgaria
"Sveta Ekaterina" Hospital
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna-ISUL" EAD
Sofia, Bulgaria
Diagnostic and Consultative Center Convex
Sofia, Bulgaria
Bc Cancer Agency
Prince George, British Columbia, Canada
Local Institution - 0002
Halifax, Nova Scotia, Canada
Local Institution - 0414
Oshawa, Ontario, Canada
Local Institution - 0178
Ottawa, Ontario, Canada
Local Institution - 0156
Toronto, Ontario, Canada
Bradford Hill Norte
Antofagasta, AN, Chile
Centro de Oncología de Precisión
Las Condes, Arica y Parinacota Region, Chile
Bradfordhill
Santiago, Santiago Metropolitan, Chile
Servicios Medicos e Investigacion Biocenter SpA
Concepción, Chile
Instituto Nacional del Cancer
Independencia, Chile
Local Institution - 0175
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Local Institution - 0141
Xiamen, Fujian, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
Local Institution - 0317
Harbin, Heilongjiang, China
Local Institution - 0046
Zhengzhou, Henan, China
Local Institution - 0430
Wuhan, Hubei, China
Local Institution - 0436
Xiangyang, Hubei, China
Local Institution - 0004
Changsha, Hunan, China
Local Institution - 0435
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Local Institution - 0177
Shenyang, Liaoning, China
Local Institution - 0014
Xi'an, Shaanxi, China
Local Institution - 0429
Jinan, Shandong, China