A Biomarker Study on Tumour Tissue in Patients with NSCLC
Research type
Research Study
Full title
A Non-interventional Biomarker Study on the Molecular Evaluation of Archival Tumor Tissue in Subjects with Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
273927
Contact name
Colin Lindsay
Contact email
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
AMG 510 is a novel investigational small molecule inhibitor of the KRAS G12C mutated protein. The KRAS G12C mutation is only present in small percentage of non-small cell lung cancer (NSCLC) patients and to date there are no approved targeted therapies for its treatment. This study is being done to identify patients with NSCLC with the KRAS G12C mutation status (positive or negative) using previously collected tumour tissue. In this non-interventional biomarker study, an archival tumour sample collected within 5 years of enrollment will be submitted for central laboratory testing with the therascreen KRAS RGQ PCR kit to identify the KRAS G12C mutation status of NSCLC patients. KRAS G12C mutation status may be considered by doctors to determine future treatment options for patients.
This KRAS testing is currently not routinely done at all centres for NSCLC.
This biomarker study is not associated with a per protocol defined prescription of a medicinal product and does not intend to decide on an assignment of the patient to a particular interventional strategy. This is a multi-center, non-interventional study evaluating detection of KRAS p.G12C in archival tumour tissue of patients with NSCLC.
The study will enroll approximately 5000 patients for approximately 3 years. Primary objective of this study is to test archival tumour tissue for KRAS p.G12C mutation from patients with non-small cell lung cancer and the endpoint is to confirm KRAS p.G12C mutation status by using a technique called the Therascreen KRAS RGQ PCR kit in patients with NSCLC.REC name
North West - Preston Research Ethics Committee
REC reference
20/NW/0101
Date of REC Opinion
13 May 2020
REC opinion
Further Information Favourable Opinion