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Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib


Aim:

1. To establish a method for identifying the mutations in the EGFR gene in small clinical
samples from lung cancer patients.

2. In a retrospective study(n=500) relate survival to the frequency and types of mutations
in the EGFR gene in a Danish population of patients with advanced, inoperable non small
cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed
towards EGFR.

3. In a prospective study (n=300), to identify the mutations in the EGFR gene in patients
treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of
mutations will be related to the expression of other parts of the EGF system, to
mutations in the gene coding for K-RAS and to treatment response.


Inclusion Criteria:



- Patients who are starting treatment with erlotinib and who has who has signed the
informed consent.

Exclusion Criteria:

- None

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

overall survival

Outcome Time Frame:

1 year after the last patient is enrolled

Safety Issue:

No

Principal Investigator

Peter Meldgaard, PhD MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Aarhus University Hospital

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

M-20080012 (ethics committee)

NCT ID:

NCT00815971

Start Date:

May 2008

Completion Date:

May 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • EGFR mutations
  • EGFR inhibitor
  • erlotinib
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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