A Study of Sotorasib (AMG 510) in Participants with Stage IV NSCLC Whose Tumors Harbor a KRAS p.G12C Mutation in Need of First-line TreatmentCodeBreaK201
Study Details
The main objective of this study is to evaluate the tumor objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in participants who receive sotorasib at either 960 mg daily or 240 mg daily whose tumors are programmed death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) < 1% and/or harbor a serine/threonine kinase 11 (STK11) co-mutation, in a subgroup of participants with PD-L1 < 1% and in a subgroup of participants with STK11 co-mutation.
Protocol Summary
Objective Response Rate (OR)
Timeframe: Up to 6 years
Disease Control Rate
Timeframe: Up to 6 years
Duration of Reponse (DOR)
Timeframe: Up to 6 years
Time to Response (TTR)
Timeframe: Up to 6 years
Progression-free Survival (PFS)
Timeframe: Up to 6 years
Overall Survival (OS)
Timeframe: Up to 6 years
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 up to Month 13
Number of Participants with a Treatment-related Adverse Event
Timeframe: Day 1 up to Month 13
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Timeframe: Baseline (Screening; up to 28 days pre-dose) up to Month 13
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiograms (ECGs)
Timeframe: Baseline (Screening; up to 28 days pre-dose) up to Month 13
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Timeframe: Baseline (Screening; up to 28 days pre-dose) up to Month 13
Maximum Plasma Concentration (Cmax) of Sotorasib
Timeframe: Day 1 up to Month 3
Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib
Timeframe: Day 1 up to Month 3
Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
Timeframe: Day 1 up to Month 3