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).

Non Small Cell Lung Cancer Clinical Trial

— REASON  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01153399
• Other study ID #: NIS-OGR-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: November 19, 2015
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 589
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
Greece	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity		Up to 2,5 years	No
Primary	Clinico-pathological characteristics according to mutation status		Up to 2,5 years	No
Secondary	Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients		Up to 3,5 years	No
Secondary	Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients		Up to 2,5 years	No
Secondary	Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR)		Up to 3,5 years	No

External Links

•   CSR_Synopsis_NIS-OGR-DUM-2010_1.pdf