DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

Last updated: October 15, 2024
Sponsor: QIAGEN Gaithersburg, Inc
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

therascreen® KRAS RGQ PCR Kit

Clinical Study ID

NCT06645236
DHF-20-1839-2
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects who consent to participate in the eligibility screen for Protocol 20210081will have their tumor tissue tested for the presence of KRAS G12C mutation under theproposed performance study.

Exclusion

Exclusion Criteria:

  • There is no separate inclusion and exclusion criteria for the performance study.

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: therascreen® KRAS RGQ PCR Kit
Phase:
Study Start date:
December 22, 2023
Estimated Completion Date:
October 31, 2030

Study 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.

Connect with a study center

  • QIAGEN Gaithersburg, Inc

    Manchester, M130BH
    United Kingdom

    Active - Recruiting

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