A Diagnostic Study of European and Japanese Advanced NSCLC Patients to Evaluate Suitable Sample Types for EGFR Testing,

This is a non-interventional diagnostic, international, multicenter and non-comparative study
of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with
adenocarcinoma and non-adenocarcinoma histologies. This study will be conducted in Japan and
Europe and will assess the concordance of EGFR mutation status derived from tumour samples
and blood based circulating free DNA. The data generated will inform the use of less-invasive
sample types in diagnostic practice. The study also aims to assess the current status of EGFR
mutation testing across Japan and Europe and gaps in currently available data including EGFR
mutation frequency in particular populations and demographic subgroups, EGFR mutation
frequency in histological subtypes of NSCLC, EGFR mutation test process and methodology,
utility of multiple sample types in the assessment of EGFR mutation status, and impact of
EGFR mutation status on therapy choice. The data may be used to drive improvements to the
EGFR mutation testing process, ensuring that patients have access to testing and are treated
appropriately on the basis of the molecular features of their disease.