Sotorasib, Panitumumab & SOC Vs SOC with/without MVASI (CodeBreaK 301)
Research type
Research Study
Full title
Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)
IRAS ID
1009278
Contact name
Matthew Rodaway
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2022-502352-31
Clinicaltrials.gov Identifier
Research summary
KRAS (Kirsten rat sarcoma) is a gene which, when mutated, sends signals to other cells that make them grow uncontrollably and often develop into cancer. KRAS mutations are common in many types of cancer including non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumours. Knowing that the KRAS p.G12C mutation is present in cancer allows the doctors to target the mutation.
The aim of this study is to compare progression free survival (defined as time from randomisation until disease progression or death from any cause) in patients with KRAS p.G12C mutated metastatic colorectal cancer (mCRC), receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without MVASI. The patients taking part will not have previously received treatment for mCRC. The study will be conducted at approximately 225 sites internationally. The study will consist of a screening period, a treatment period, a safety follow-up period and a long-term follow-up period. Approximately 450 subjects with mCRC with KRAS p.G12C mutation, who have not received treatment for this before will be enrolled and randomised (selected by chance) to receive either the experimental arm (Sotorasib, Panitumumab and FOLFIRI) or the control arm (FOLFIRI with or without MVASI). Investigator’s decision regarding use of MVASI will need to be declared prior to randomisation.
Tumour assessments will be conducted by contrast-enhanced computerised tomography (CT) and/or magnetic resonance imaging (MRI) at baseline and then every 8 weeks (+/- 7 days) from randomisation.
Subjects will be followed for up to 5 years after last subject randomised, or until withdrawal of consent, lost to follow-up, end of study, or subject death, whichever occurs first.
The final study analysis will be performed after all patients have ended the study.REC name
East Midlands - Derby Research Ethics Committee
REC reference
24/EM/0173
Date of REC Opinion
11 Sep 2024
REC opinion
Further Information Favourable Opinion