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).

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01153399

Acronym

REASON

Enrollment

589

Registered

2010-06-30

Start date

2010-10-31

Completion date

2014-12-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer, EGFR mutations

Brief 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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity	Up to 2,5 years
Clinico-pathological characteristics according to mutation status	Up to 2,5 years

Secondary

Measure	Time frame
Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients	Up to 3,5 years
Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients	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)	Up to 3,5 years

Countries

Greece

Outcome results