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.
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer
Both
Non Small Cell Lung Cancer
Trial Information
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity
Outcome Time Frame:
Up to 2,5 years
Safety Issue:
No
Principal Investigator
Panagiotis Pontikis
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Greece: National Organization of Medicines
Study ID:
NIS-OGR-DUM-2010/1
NCT ID:
NCT01153399
Start Date:
October 2010
Completion Date:
March 2014
Related Keywords:
- Non Small Cell Lung Cancer
- Non Small Cell Lung Cancer
- EGFR mutations
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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