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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Oral tablet
Objective Response Rate (OR)
OR is defined as the total of Complete Response (CR) and Partial Response (PR).
Time frame: Up to 6 years
Disease Control Rate
Time frame: Up to 6 years
Duration of Reponse (DOR)
Time frame: Up to 6 years
Time to Response (TTR)
Time frame: Up to 6 years
Progression-free Survival (PFS)
Time frame: Up to 6 years
Overall Survival (OS)
Time frame: Up to 6 years
Number of Participants with a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 up to Month 13
Number of Participants with a Treatment-related Adverse Event
Time frame: Day 1 up to Month 13
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
Time frame: 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)
Time frame: 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
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Alabama Oncology
Birmingham, Alabama, United States
Arizona Oncology Associates Professional Corporation
Tucson, Arizona, United States
City of Hope at Long Beach Elm
Duarte, California, United States
City of Hope National Medical Center
Duarte, California, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
Northwest Georgia Oncology Centers PC
Marietta, Georgia, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Frederick Memorial Hospital
Frederick, Maryland, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
...and 57 more locations
Time frame: Baseline (Screening; up to 28 days pre-dose) up to Month 13
Maximum Plasma Concentration (Cmax) of Sotorasib
Time frame: Day 1 up to Month 3
Time to Reach Maximum Plasma Concentration (tmax) of Sotorasib
Time frame: Day 1 up to Month 3
Area Under the Plasma Concentration-time Curve (AUC) of Sotorasib
Time frame: Day 1 up to Month 3