A Phase 3 Study of MRTX849 with Cetuximab vs Chemotherapy in Advanced Colorectal Cancer
Research type
Research Study
Full title
A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First- Line Therapy
IRAS ID
1003772
Contact name
Hirak Der-Torossian
Contact email
Sponsor organisation
Mirati Therapeutics, Inc.
Eudract number
2020-004048-27
Clinicaltrials.gov Identifier
Research summary
Study 849-010 is an open label, randomised, Phase 3 clinical trial comparing the effectiveness of the investigational (experimental) medication MRTX849 administered in combination with the cancer therapy cetuximab (investigational arm) versus standard of care second-line treatment consisting of either FOLFIRI or mFOLFOX6 chemotherapy (comparator arm) in patients with advanced colorectal cancer (CRC) who have a specific change in tumour genes (KRAS G12C mutation) and who are experiencing progression on or after first-line chemotherapy.
Eligible participants will be randomly assigned to one of two treatment groups (investigational or comparator arms). Treatment on the comparator arm with either FOLFIRI or mFOLFOX6 is determined by the patient’s first-line treatment regimen. Patients who received prior irinotecan as part of a chemotherapy regimen will receive mFOLFOX6; patients who received prior oxaliplatin as part of a chemotherapy regimen will receive FOLFIRI.
Study treatment for both the investigational and comparator will be administered in 4-week (28-day) cycles until one of the indications for stopping treatment are identified.
This study is expected to be conducted at approximately 300 study sites globally and enroll approximately 420 patients.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0222
Date of REC Opinion
21 Sep 2021
REC opinion
Further Information Favourable Opinion