Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit

• Sponsor: QIAGEN Gaithersburg, Inc (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05348187
• Collaborator: Amgen (Industry)
• Enrollment: 309
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 8.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer; Colorectal Cancer	Diagnostic Test: therascreen® KRAS RGQ PCR Kit	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 309 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Specimens from advanced NSCLC and CRC patient tumor samples, will be extracted and tested with the therascreen® KRAS RGQ PCR Kit. The sample KRAS G12C mutation status, if known by a previous testing method, will be blinded to device investigation site personnel at NeoGenomics.
• Primary Purpose: Diagnostic
• Official 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).
• Actual Study Start Date: Jul 1, 2019
• Actual Primary Completion Date: Jan 26, 2021
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

Other: Clinical Performance Study Protocol for 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.

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

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	QIAGEN Gaithersburg, Inc	Manchester		United Kingdom	M130BH

Sponsors and Collaborators

• QIAGEN Gaithersburg, Inc
• Amgen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: QIAGEN Gaithersburg, Inc
• ClinicalTrials.gov Identifier: NCT05348187
• Other Study ID Numbers: QMAN-18-0181-1-001
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Study Results

No Results Posted as of Apr 27, 2022