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NCT Number: NCT01153399

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).

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).

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Athens, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity

    Time frame: Up to 2,5 years

  2. Clinico-pathological characteristics according to mutation status

    Time frame: Up to 2,5 years

Secondary outcomes

  1. Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients

    Time frame: Up to 3,5 years

  2. Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients

    Time frame: Up to 2,5 years

  3. Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR)

    Time frame: Up to 3,5 years

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)-REASON STUDY.

Acronym: REASON

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 30, 2010
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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