DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: therascreen® KRAS RGQ PCR Kit.
- Who it may be relevant to
- Registry conditions: Metastatic Colorectal Cancer (mCRC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device therascreen® KRAS RGQ PCR Kit
The investigational device, therascreen® KRAS RGQ PCR Kit, will be used to determine the KRAS G12C mutation status of patients during the screening period of Amgen's clinical trial (20210081)
Primary outcome measures
- Detection of KRAS G12C mutation status [Time frame: 6 years; due to end 2030]
- Progression Free Survival (PFS) [Time frame: 6 years; due to end 2030]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 1 center
- QIAGEN Gaithersburg, Inc — Manchester
Identifiers
NCT: NCT06645236 · DHF-20-1839-2