A Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer). (REASON)

AstraZeneca

Status: Completed

Conditions: Non Small Cell Lung Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01153399

NIS-OGR-DUM-2010/1

Details and patient eligibility

About

The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

Enrollment: 589 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed written informed consent.
2. Female or male aged 18 years or above.
3. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
4. Patients receiving 1st-line treatment for IIIB/IV NSCLC.
5. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
6. Tumour not amenable to curative surgery or radiotherapy.

Exclusion criteria

1. Mixed histology of small cell and non-small cell lung cancer.

Trial design

589 participants in 1 patient group

1

Description:

Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics