Europe-Japan Diagnostic Study for EGFR Testing (ASSESS)

AstraZeneca

Status: Completed

Conditions: EGFR Mutation Status in aNSCLC Patients (Locally Advanced and/or Metastatic Disease) With Adenocarcinoma and Non-adenocarcinoma Histologies.

Study type: Observational

Funder types: Industry

Identifiers

NCT01785888

D7913C00070

Details and patient eligibility

About

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.

Full description

A diagnostic Study of European and Japanese advanced NSCLC patients to evaluate suitable sample types for EGFR testing,

Enrollment: 1,311 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 18 years and older in Europe and aged 20 years and older in Japan
• Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC.
• Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naïve (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
• Provision of diagnostic cancer tissue or cytology sample upon inclusion
• Provision of a routine blood sample

Exclusion criteria

• Evidence of severe or uncontrolled systemic disease
• Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
• Pregnancy or breast-feeding

Trial design

1,311 participants in 1 patient group

Locally advanced/metastatic NSCLC pts.

Description:

Patients(pts.) with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)