NCT05348187

Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

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).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 309 (actual)
• Sponsor: QIAGEN Gaithersburg, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	therascreen® KRAS RGQ PCR Kit	The primary objective is to utilize a clinical trial assay, the therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 2 of Amgen clinical trial, in order to identify patients (with NSCLC and CRC) with KRAS G12C mutation positive tumors

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-11-23
• Completion: 2020-11-23
• First posted: 2022-04-27
• Last updated: 2024-11-04

Locations

1 site across 1 country: United Kingdom