Non Small Cell Lung Cancer Clinical Trial
— REASONOfficial 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.
Verified date | November 2015 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
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).
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. |
Observational Model: Case-Only, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Greece,
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 |
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