Genetics of EGFR Mutation Study (GEM): a Translational Study of the EORTC Lung Group.
Objective 1: To identify germline allelic DNA variation associated with somatic EGFR
mutation in NSCLC, Objective 2: Correlation between germline allelic variants and survival
in EGFR somatic mutant NSCLC.
Objective 3: Study germline allelic DNA variation associated with never /ex light smoking
Objective 4: Catalogue distribution of somatic EGFR mutant genotypes in 1,000 EGFR mutant
NSCLC cases and describe their relationship to clinical outcome.
- Histologically or cytologically diagnosed NSCLC, all histologies are acceptable.
- Patients can be included in the study with any disease stage and at any time during
the disease course.
- Any type (surgery, RadioTherapy, chemotherapy, targeted agents) of previous treatment
and any line of treatment are eligible.
- Age ≥18 years.
Absence of any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol; those conditions should be discussed with
the patient before registration in the trial.
Before patient registration, written informed consent must be given according to ICH/GCP
(International Conference on Harmonisation/Good Clinical Practice), and national/local
Type of Study:
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
For the second objective, the primary endpoint is Overall survival (OS)
Outcome Time Frame:
5 years from FPI
Sanjay Popat, MD
Royal Marsden Hospital, Chelsea, London, UK
Belgium: Federal Agency for Medicinal Products and Health Products
- EGFR Mutation Positive Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms