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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)

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: June 25, 2010
Last updated: November 19, 2015
Last verified: November 2015
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).

Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity [ Time Frame: Up to 2,5 years ]
  • Clinico-pathological characteristics according to mutation status [ Time Frame: Up to 2,5 years ]

Secondary Outcome Measures:
  • Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients [ Time Frame: Up to 3,5 years ]
  • 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 ]
  • 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 ]

Enrollment: 589
Study Start Date: October 2010
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Non Small Cell Lung Cancer

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01153399

Research Site
Athens, Greece
Research Site
Crete, Greece
Research Site
Ioannina, Greece
Research Site
Kavala, Greece
Research Site
Larisa, Greece
Research Site
Patra, Greece
Research Site
Ptolemaida, Greece
Research Site
Thessaloniki, Greece
Research Site
Volos, Greece
Sponsors and Collaborators
Study Director: Panagiotis Pontikis AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01153399     History of Changes
Other Study ID Numbers: NIS-OGR-DUM-2010/1
Study First Received: June 25, 2010
Last Updated: November 19, 2015

Keywords provided by AstraZeneca:
Non Small Cell Lung Cancer
EGFR mutations

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on May 25, 2017