NCT05347797

Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit

Phase 3 Multicentre, Prospective, Interventional Clinical Study Testing DNA Extracted From Tumour Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer, Screened in Clinical Study (Protocol No. 20190009).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 495 (actual)
• Sponsor: QIAGEN Gaithersburg, Inc · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

An interventional, prospective study. It is estimated that up to 800 patient tissue samples (from approximately 650 patients enrolled at approximately 300 clinical trial sites), will be obtained as part of enrolment into Phase 3 of Clinical Study (Protocol No. 20190009), for testing using the therascreen® KRAS RGQ PCR Kit (KRAS Kit).

Detailed description

This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\]) tumour tissue ) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit. Up to 800 patient tissue samples (from approximately 300 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190009), will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China. The primary objective of the Clinical Study (Protocol No. 20190009) is to evaluate tumour objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Study Assay, KRAS Kit to assess whether to treat patients with KRAS G12Cmutated advanced tumours (NSCLC). 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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	therascreen® KRAS RGQ PCR Kit	To utilize a Clinical Study assay, the therascreen® KRAS RGQ PCR Kit, as a screening test in Phase 3 of Clinical Study (Protocol No. 20190009), in order to identify patients with NSCLC with KRAS G12C mutation positive tumours.

Timeline

• Start date: 2020-03-13
• Primary completion: 2021-04-22
• Completion: 2021-04-22
• First posted: 2022-04-26
• Last updated: 2024-11-04

Locations

1 site across 1 country: United Kingdom