Sotorasib and Panitumumab Versus Investigator’s Choice for Subjects with KRAS p.G12C Mutation
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ABSTRACT: Main Objective: •To compare progression free survival (PFS) in previously treated subjects with KRAS p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator’s choice (trifluridine and tipiracil or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator’s choice (trifluridine and tipiracil or regorafenib)
Primary end point(s): •Progression Free Survival (PFS) – defined as time from randomization
until disease progression or death from any cause, whichever occurs
first, for all subjects. Progression will be assessed using, use Response
Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per Blinded
Independent Central Review (BICR)
DISEASE(S): Previously Treated Metastatic Colorectal Cancer Subjects With Kras P.g12c Mutation,Metastatic Colorectal Cancer
PROVIDER: 2541579 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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