Clinical trial 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).
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
EGFR mutations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 589
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Non Small Cell Lung Cancer

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity
timeFrame: Up to 2,5 years
measure: Clinico-pathological characteristics according to mutation status
timeFrame: Up to 2,5 years
Secondary outcomes:
measure: Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients
timeFrame: Up to 3,5 years
measure: Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients
timeFrame: Up to 2,5 years
measure: Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR)
timeFrame: Up to 3,5 years
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Research Site
city: Crete
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Kavala
country: Greece
facility: Research Site
city: Larisa
country: Greece
facility: Research Site
city: Patra
country: Greece
facility: Research Site
city: Ptolemaida
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Volos
country: Greece
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Panagiotis Pontikis
role: STUDY_DIRECTOR
References: