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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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00815971
Enrollment
300
Registered
2008-12-31
Start date
2008-05-31
Completion date
2011-05-31
Last updated
2008-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Keywords

EGFR mutations, EGFR inhibitor, erlotinib

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

University of Aarhus
CollaboratorOTHER
The Ministry of Science, Technology and Innovation, Denmark
CollaboratorOTHER_GOV
Hoffmann-La Roche
CollaboratorINDUSTRY
Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
overall survival1 year after the last patient is enrolled

Secondary

MeasureTime frame
response( according to RECIST)3 month after the last patient is enrolled
quality of live ( measured by EORTC PAL 15)3 month after the last patient is enrolled

Countries

Denmark

Contacts

Primary ContactBritta Weber, MD
doctorweber@stofanet.dk+4589493333
Backup ContactPeter Meldgaard, PhD MD
peter.meldgaard@dadnnet.dk+4589493333

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026