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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00815971
• Other study ID #: M-20080012 (ethics committee)
• Status: Recruiting
• Phase: N/A
• First received: December 30, 2008
• Last updated: December 30, 2008
• Start date: May 2008
• Est. completion date: May 2011

Study information

• Verified date: December 2008
• Source: Aarhus University Hospital
• Contact: Britta Weber, MD
• Phone: +4589493333
• Email: doctorweber[@]stofanet.dk
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Observational

Clinical Trial Summary

Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.

The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.

In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.

The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Locations

Country	Name	City	State
Denmark	department of oncology, University Hospital of Aarhus, Nørrebrogade 44	8000 Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
Aarhus University Hospital	Hoffmann-La Roche, The Ministry of Science, Technology and Innovation, Denmark, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		1 year after the last patient is enrolled	No
Secondary	response( according to RECIST)		3 month after the last patient is enrolled	No
Secondary	quality of live ( measured by EORTC PAL 15)		3 month after the last patient is enrolled	No