* Sotorasib and Panitumumab vs Investigator’s Choice in CRC Patients
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib and Panitumumab Versus Investigator’s Choice (Trifluridine and Tipiracil, or Regorafenib) for the Treatment of Previously Treated Metastatic Colorectal Cancer Subjects with KRAS p.G12C Mutation
IRAS ID
305777
Contact name
Janet Graham
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2021-004008-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 14 days
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 main objective of the study is to compare progression free survival (defined as time from randomisation until disease progression or death from any cause) in previously treated participants with KRAS p.G12C mutated colorectal cancer receiving sotorasib and panitumumab vs investigator’s choice (trifluridine and tipiracil or regorafenib). The study will be conducted at approximately 100 sites. The study will consist of a screening period, a treatment period, a safety follow-up and long-term follow-up period. Approximately 153 previously treated metastatic CRC participants with KRAS p.G12C mutation will be enrolled and randomised 1:1:1 to receive either sotorasib 240 mg once daily and panitumumab or sotorasib 960 mg once daily and panitumumab or investigator’s choice (trifluridine and tipiracil, or regorafenib).
Tumour assessment will be conducted by magnetic resonance imaging (MRI) and/or contrast-enhanced computerised tomography (CT) at baseline, at 8 week intervals until blinded independent central review (BICR) confirmed progression, start of another anti cancer therapy, withdrawal of consent, loss to follow-up, or death, whichever occurs earliest.
An independent (external to Amgen) data monitoring committee (DMC) is planned for this study to review safety data as per DMC charter.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0155
Date of REC Opinion
25 Jan 2022
REC opinion
Further Information Favourable Opinion