Screening for KRAS G12C mutations in metastatic colorectal cancer
Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen® KRAS RGQ PCR Kit
This study is testing a new kit to find out if people with metastatic colorectal cancer have a specific mutation so they can join a trial looking at a new treatment combination.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | QIAGEN Gaithersburg, Inc Industry-sponsored |
| Drugs / interventions | Panitumumab, Bevacizumab |
| Locations | 1 site (Manchester, Manchester) |
| Trial ID | NCT06645236 on ClinicalTrials.gov |
What this trial studies
This study utilizes the therascreen KRAS RGQ PCR Kit to identify patients with metastatic colorectal cancer (mCRC) who have KRAS G12C mutation positive tumors. The results will be used to enroll eligible patients in Amgen's Phase 3 clinical trial evaluating the efficacy of sotorasib in combination with other treatments. Approximately 450 patients from 31 countries will participate, and the study aims to establish the clinical performance of the therascreen kit as a companion diagnostic for mCRC. The trial will be conducted in conjunction with the Phase 3 study to streamline patient identification and enrollment.
Who should consider this trial
Good fit: Ideal candidates are treatment-naïve patients with metastatic colorectal cancer who have a KRAS G12C mutation.
Not a fit: Patients without the KRAS G12C mutation or those who have previously received treatment for mCRC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for identifying mCRC patients who may benefit from targeted treatment with sotorasib.
How similar studies have performed: Other studies have shown success with similar companion diagnostic approaches, indicating potential for this method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study. Exclusion Criteria: * There is no separate inclusion and exclusion criteria for the performance study.
Where this trial is running
Manchester, Manchester
- QIAGEN Gaithersburg, Inc — Manchester, Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Sarah Johnson, Dr.
- Email: sarah.johnson@qiagen.com
- Phone: 0044 07825866041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.