Clinical trial NCT00815971: 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
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Small Cell Lung Cancer
Keywords: EGFR mutations
EGFR inhibitor
erlotinib
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: The Ministry of Science, Technology and Innovation, Denmark
name: Hoffmann-La Roche
First posted: 2008-12-31
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-small cell lung cancer who will start treatment with 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: overall survival
timeFrame: 1 year after the last patient is enrolled
Secondary outcomes:
measure: response( according to RECIST)
timeFrame: 3 month after the last patient is enrolled
measure: quality of live ( measured by EORTC PAL 15)
timeFrame: 3 month after the last patient is enrolled
Other outcomes:
Locations:
city: 8000 Aarhus
country: Denmark
facility: department of oncology, University Hospital of Aarhus, Nørrebrogade 44
Study officials:
affiliation: Aarhus University Hospital
name: Peter Meldgaard, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sorensen BS, Wu L, Wei W, Tsai J, Weber B, Nexo E, Meldgaard P. Monitoring of epidermal growth factor receptor tyrosine kinase inhibitor-sensitizing and resistance mutations in the plasma DNA of patients with advanced non-small cell lung cancer during treatment with erlotinib. Cancer. 2014 Dec 15;120(24):3896-901. doi: 10.1002/cncr.28964. Epub 2014 Aug 7.
citation: Weber B, Meldgaard P, Hager H, Wu L, Wei W, Tsai J, Khalil A, Nexo E, Sorensen BS. Detection of EGFR mutations in plasma and biopsies from non-small cell lung cancer patients by allele-specific PCR assays. BMC Cancer. 2014 Apr 28;14:294. doi: 10.1186/1471-2407-14-294.