A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)
Summary
The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Arms & interventions
- DrugSotorasib
Oral administration
- DrugPembrolizumab
Intravenous administration
Outcome measures
Primary
Progression-free Survival (PFS)
PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR).
Time frame: Approximately 2.5 years
Overall Survival (OS)
OS is defined as the time from randomization until death due to any cause.
Time frame: Approximately 2.5 years
Secondary
Objective Response Rate (ORR)
Time frame: From Baseline up to end of study (EOS) (approximately 5.5 years)
Change in Quality-of-Life Questionnaire Core 30 (QLQ-C30) Dyspnea Domain Score
Time frame: From Baseline to Week 12
Change in Quality-of-Life Questionnaire Lung Cancer 13 (QLQ-LC13) Symptoms of Dyspnea Subscale
Time frame: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Cough Subscale
Time frame: From Baseline to Week 12
Change in QLQ-LC13 Symptoms of Chest Pain Subscale
Time frame: From Baseline to Week 12
Change in Physical Function as Measured by QLQ-C30
Time frame: From Baseline to Week 12
Change in Global Health Status as Measured by QLQ-C30
Time frame: From Baseline to Week 12
Progression-free Survival 2 (PFS2)
Time frame: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-LC13 Subscale Scores
Time frame: From Baseline up to EOS (approximately 5.5 years)
Change in QLQ-C30 Subscale Scores
Time frame: From Baseline up to EOS (approximately 5.5 years)
Time to Deterioration in QLC-LC13 Subscale Scores
Time frame: From Baseline to Week 12
Time to Deterioration in QLC-C30 Subscale Scores
Time frame: From Baseline to Week 12
Change in Summary Scores and Visual Analogue Scale (VAS) Scores
Time frame: From Baseline up to EOS (approximately 5.5 years)
Duration of Response
Time frame: From Baseline up to EOS (approximately 5.5 years)
Time to Response
Time frame: From Baseline up to EOS (approximately 5.5 years)
Disease Control
Time frame: From Baseline up to EOS (approximately 5.5 years)
PFS
Time frame: From Baseline up to EOS (approximately 5.5 years)
Objective Response
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: From Baseline up to EOS (approximately 5.5 years)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests
Time frame: From Baseline up to EOS (approximately 5.5 years)
Maximum Plasma Concentration (Cmax) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
Minimum Plasma Concentration (Cmin) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
Area Under The Curve (AUC) of Sotorasib
Time frame: Pre-dose Day 1 up to Day 64
Eligibility criteria
Study locations (21)
Sansum Clinic
Santa Barbara, California, 93105
Medical Oncology Hematology Consultants Helen F Graham Cancer Center
Newark, Delaware, 19713
University of Illinois Chicago
Chicago, Illinois, 60612
Illinois Cancer Specialists
Niles, Illinois, 60714
Norton Cancer Institute - Brownsboro
Louisville, Kentucky, 40241
Reliant Medical Group Inc
Worcester, Massachusetts, 01606
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Messino Cancer Centers Asheville
Asheville, North Carolina, 28806
Duke University Medical Center
Durham, North Carolina, 27710
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
Alliance Cancer Specialists - Media
Media, Pennsylvania, 19063
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Regional One Health
Memphis, Tennessee, 38103
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
Oncology Consultants PA
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
US Oncology Research Investigational Products Center
Irving, Texas, 75063
Vista Oncology Inc PS
Olympia, Washington, 98506
Mercyhealth
Janesville, Wisconsin, 53548