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%.
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%.
Arms & interventions
- DrugPumitamig
Specified dose on specified days
- DrugPembrolizumab
Specified dose on specified days
Outcome measures
Primary
Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: Up to approximately 3 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Secondary
PFS by investigator according to RECIST v1.1
Time frame: Up to approximately 3 years
Objective Response (OR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Duration of response (DOR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Disease control rate (DCR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Time to Response (TTR) by BICR according to RECIST v1.1
Time frame: Up to approximately 3 years
Time to definitive deterioration (TTDD) based on the Non-Small Cell Lung Cancer-Symptom Assessment Questionnaire (NSCLC-SAQ) defined as the time from randomization until a definitive clinically meaningful worsening in symptoms or in NSCLC-SAQ total score
Time frame: Up to approximately 3 years
Eligibility criteria
Study locations (40)
Southern Cancer Center Pc
Daphne, Alabama, 36526
Local Institution - 0424
Bullhead City, Arizona, 86442
Local Institution - 0391
Glendale, Arizona, 85304
Local Institution - 0407
Anaheim, California, 92801
Local Institution - 0352
Beverly Hills, California, 90211
Orange Coast Memorial Medical Center
Fountain Valley, California, 92708
Local Institution - 0027
Los Alamitos, California, 90720
Local Institution - 0422
Los Angeles, California, 90095
Local Institution - 0403
Oakland, California, 94611
Local Institution - 0208
Pleasant Hill, California, 94523
Local Institution - 0416
Walnut Creek, California, 94598
Local Institution - 0340
Lakewood, Colorado, 80401
Clermont Oncology Center
Clermont, Florida, 34711
Advanced Research
Coral Springs, Florida, 33321
BRP- Hialeah Hospital
Hialeah, Florida, 33013
University Cancer & Blood Center, LLC
Athens, Georgia, 30607
Local Institution - 0412
Augusta, Georgia, 30912
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
Local Institution - 0423
Urbana, Illinois, 61801
Northwest Cancer Centers, P.C.
Dyer, Indiana, 46311
Missouri Cancer Associates
Columbia, Missouri, 65201
Local Institution - 0224
Laurelton, New York, 11413
Local Institution - 0026
New York, New York, 10065
Local Institution - 0214
Westbury, New York, 11590
Local Institution - 0283
Winston-Salem, North Carolina, 27103
Local Institution - 0383
Cincinnati, Ohio, 45220
Local Institution - 0418
Oklahoma City, Oklahoma, 73109
Local Institution - 0288
Lancaster, Pennsylvania, 17601
Local Institution - 0028
Pittsburgh, Pennsylvania, 15212
WellSpan Oncology Research
York, Pennsylvania, 17403
Local Institution - 0376
Galveston, Texas, 77555
Kelsey-Seybold Clinic Main Campus
Houston, Texas, 77025
Texas Oncology - San Antonio
San Antonio, Texas, 78217
Local Institution - 0381
San Antonio, Texas, 78260
Local Institution - 0337
Richmond, Virginia, 23298
Shenandoah Oncology, P.C.
Winchester, Virginia, 22601
Local Institution - 0384
Spokane, Washington, 99218
Local Institution - 0339
Charleston, West Virginia, 25304
Local Institution - 0380
Green Bay, Wisconsin, 54301
Local Institution - 0421
Marshfield, Wisconsin, 54449