The study is an double blind, randomized, multicenter phase 3 trial. The efficacy analyses
are based on 570 Chinese patients with RAS wt mCRC treated with mFOLFOX-6 ± cetuximab. Study
treatment continues until disease progression or unacceptable toxicity (ie, not for a fixed
number of courses). The primary endpoint of the study is progression-free survival (PFS) time
according to RECIST 1.0; key secondary endpoints include overall survival (OS) time, overall
response rate (ORR), and safety/tolerability.
Phase:
Phase 3
Details
Lead Sponsor:
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.