Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Cancer; Colorectal Cancer
• Interventions: Diagnostic Test: therascreen® KRAS RGQ PCR Kit

• Registration Number: NCT05348187
• Lead Sponsor: QIAGEN Gaithersburg, Inc

Brief Summary

An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer and Colorectal Cancer, screened in Amgen's clinical trial (Protocol No. 20170543).

Detailed Description

This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples (either core needle (NSCLC only) or excisional biopsies), obtained from patients with Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), using the therascreen® KRAS RGQ PCR Kit, (hereafter referred to as KRAS Kit).

Up to 280 patient tissue samples (from approximately 100 clinical study sites), obtained in the Amgen Clinical Protocol 20170543 study, will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing site, NeoGenomics Laboratories, Inc., 7256 S. Sam Houston Pkwy W., Suite 300, Houston, Texas, 77085, USA.

The primary objective of the Amgen Clinical Study is to evaluate tumor objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Trial Assay, therascreen® KRAS RGQ PCR Kit to assess whether to treat patients with KRAS G12C mutated advanced tumors (NSCLC and CRC).

The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-11-23
• Study Completion: 2020-11-23
• Study First Submitted: 2022-04-01
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-27
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

Inclusion Criteria

• All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.

Exclusion Criteria

• Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinical Performance Study Protocol for therascreen® KRAS RGQ PCR Kit	therascreen® KRAS RGQ PCR Kit	The therascreen KRAS RGQ PCR Kit is a real-time qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of somatic G12C mutations in the human KRAS oncogene using DNA extracted from formalin fixed paraffin-embedded (FFPE) Colorectal Cancer (CRC) and Non-small Cell Lung Cancer (NSCLC) tissue. The therascreen KRAS RGQ PCR Kit is intended to aid in the identification of cancer patients who may be eligible for treatment with AMG 510.

Primary Outcome Measures

Name	Time	Method
therascreen® KRAS RGQ PCR Kit	5 business days	therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 2 of clinical trial (Protocol 20170543), in order to identify patients (with NSCLC and CRC) with KRAS G12C mutation positive tumors for inclusion in study (Protocol 20170543)

Trial Locations

Locations (1)

QIAGEN Gaithersburg, Inc; 🇬🇧 Manchester, United Kingdom