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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QIAGEN Gaithersburg, Inc

Manchester, M130BH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

therascreen® KRAS RGQ PCR Kit

Diagnostic Test

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

Primary outcomes

therascreen® KRAS RGQ PCR Kit

Time frame: 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)

Sponsors and collaborators

Lead sponsor

QIAGEN Gaithersburg, Inc

Industry

Collaborators

Amgen

Registry information

Official study title

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).

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Apr 27, 2022
Registry last updated: Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed