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

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.

Study Overview

• Status: Unknown
• Conditions: Non-Small Cell Lung Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Denmark
  • 8000 Aarhus, Denmark
    • Recruiting
    • department of oncology, University Hospital of Aarhus, Nørrebrogade 44
    • Contact: Britta Weber, MD; Phone Number: +4589493333; Email: doctorweber@stofanet.dk
    • Contact: Peter meldgaard, PhD MD; Phone Number: +4589493333; Email: peter.meldgaard@dadlnet.dk
    • Principal Investigator: Peter meldgaard, PhD MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with non-small cell lung cancer who will start treatment with erlotinib

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
NSCLC; Patients with non-small cell lung cancer carcinoma treated with erlotinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	1 year after the last patient is enrolled

Secondary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Hoffmann-La Roche; University of Aarhus; The Ministry of Science, Technology and Innovation, Denmark
• Investigators: Principal Investigator: Peter Meldgaard, PhD MD, Aarhus University Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): May 1, 2011
• Study Completion (Anticipated): May 1, 2011

Study Registration Dates

• First Submitted: December 30, 2008
• First Submitted That Met QC Criteria: December 30, 2008
• First Posted (Estimate): December 31, 2008

Study Record Updates

• Last Update Posted (Estimate): December 31, 2008
• Last Update Submitted That Met QC Criteria: December 30, 2008
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: erlotinib; EGFR mutations; EGFR inhibitor
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: M-20080012 (ethics committee)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No