DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Registration Number
- NCT06645236
- Lead Sponsor
- QIAGEN Gaithersburg, Inc
- Brief Summary
To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.
- Detailed Description
The proposed device clinical performance study and the medicinal clinical trial will be conducted simultaneously as a combined trial according to MDCG 2022-10. The clinical trial 20210081 is a 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). It is estimated that approximately 450 patients from 31 countries will be enroled based on the presence of tumor KRAS G12C mutation, detected using therascreen KRAS RGQ PCR Kit, along with other clinical trial inclusion criteria, into the Phase III clinical trial. Results from the Phase 3 Amgen Study 20210081 will be used to evaluate the clinical performance of therascreen® KRAS RGQ PCR Kit as a CDx device for identification of patients with mCRC who may benefit from treatment with sotorasib in treatment-naïve patients with metastatic colorectal cancer.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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.
- There is no separate inclusion and exclusion criteria for the performance study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Detection of KRAS G12C mutation status 6 years; due to end 2030 Detection of the KRAS G12C mutation status in DNA extracted from Formalin-Fixed Paraffin-Embedded (FFPE), CRC tissue using the therascreen KRAS RGQ PCR Kit to enrol approximately 450 KRAS G12C positive patients for clinical study protocol 20210081.
Progression Free Survival (PFS) 6 years; due to end 2030 The primary efficacy endpoint is progression free survival (PFS), defined as time from randomization until disease progression or death from any cause, whichever occur first as per the sotorasib clinical trial (Protocol 2021008).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
QIAGEN Gaithersburg, Inc
🇬🇧Manchester, United Kingdom