Screening for KRAS G12C mutations in metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• QIAGEN Gaithersburg, Inc
  Manchester, Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Sarah Johnson, Dr.
• Email: sarah.johnson@qiagen.com
• Phone: 0044 07825866041

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.