Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial

Summary

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.

Timeline

Start

2018-03-18

Primary completion

2021-11-27

Completion

2021-11-27

Outcome

Outcome not reported

Stopped (Business): “Due to adjustments in our R\&D strategy, we are discontinuing the 140-III-01 study and initiating the 140-III-02 study.”

Drugs

Indications