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 (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Blinded Independent Central Review (BICR)
Objective response was defined as best overall response (BOR) of complete response (CR) or partial response (PR), as defined by RECIST 1.1. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. Progressive disease (PD) was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Responses were assessed based on BICR.
Time frame: From the first dose of trial drug until min (last dose + 30 days, end of trial [EOT]); median [min, max] duration was 5.32 [0.8, 30.9] months
Disease Control Rate (DCR) Per RECIST Version 1.1 as Assessed by BICR
DCR was defined as the percentage of participants with an OR or stable disease (SD) per RECIST v1.1. CR: disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \<10 mm. PR: at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study).
Time frame: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months
Duration of Response (DOR) Per RECIST Version 1.1 as Assessed by BICR
DOR was defined as time from the first documentation of OR subsequently confirmed until the first documentation of PD or death due to any cause, whichever comes first. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
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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: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months
Time to Response (TTR) Per RECIST Version 1.1 as Assessed by BICR
TTR was defined as time from first dose date to the first documentation of PR or CR subsequently confirmed. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Time frame: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months
Progression-free Survival (PFS) as Assessed by BICR
PFS by BICR was defined as the time from first dose date to disease progression or death due to any cause (whichever comes first). PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions.
Time frame: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months
Overall Survival (OS)
OS was defined as the time from first dose date until event of death due to any cause.
Time frame: From randomization until EOT; median [min, max] time on trial was 9.72 [0.8, 38.0] months
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-related TEAEs
TEAEs are AEs starting on or after the first dose of sotorasib as determined by the flag indicating if the AE started prior to the first dose on the Events case report form (CRF) and up to and including 30 days after the last dose of sotorasib or the EOT date, whichever is earlier. A treatment-related TEAE is any TEAE with the relationship flag on the events CRF indicating there is a reasonable possibility that the event may have been caused by investigational medicinal product. Clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests were included as TEAEs.
Time frame: From the first dose of trial drug until min (last dose + 30 days, EOT); median [min, max] duration was 5.32 [0.8, 30.9] months
Plasma Concentration of Sotorasib
Blood samples were collected at specified timepoints.
Time frame: Cycles 1 and 2: Day 1 pre-dose and 1 hour post-dose; Cycles 3, 4 and, 5: Day 1 pre-dose (cycle length = 21 days)