Clinical trial NCT06645236: DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: Metastatic Colorectal Cancer
therascreen
KRAS G12C
sotorasib
Clinical Performance Study
Companion Diagnostic
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2024-10-16
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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.

Primary outcomes:
measure: Detection of KRAS G12C mutation status
timeFrame: 6 years; due to end 2030
measure: Progression Free Survival (PFS)
timeFrame: 6 years; due to end 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc
Study officials:
affiliation: Qiagen Manchester Limited
name: Sarah Johnson, Dr.
role: STUDY_DIRECTOR
References: