A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
345
Progression-free Survival (PFS)
PFS was defined as the time from randomization (baseline) until disease progression or death from any cause, whichever occurred first for all participants. Progression was based on blinded independent central review (BICR) of disease response per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). As pre-specified in the statistical analysis plan, for participants who crossed over from docetaxel to AMG 510, the participant's response post first progression or post crossover was not used for the primary analyses. Data are presented per original treatment randomized.
Time frame: Baseline up to primary analysis data cut-off date (02 August 2022); max time on study as of primary analysis data cut off was 24.3 months
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Pacific Cancer Medical Center Inc
Anaheim, California, United States
City of Hope National Medical Center
Duarte, California, United States
Pacific Shores Medical Group Long Beach
Long Beach, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
Ridley Tree Cancer Center
Santa Barbara, California, United States
University of California San Francisco Mission Hall
Stanford, California, United States
Harbor University of California Los Angeles Medical Center
Torrance, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
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