A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response
Conditions
Non-small Cell Lung Cancer Metastatic - Non-small Cell Lung Cancer Recurrent
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
Summary
1. Trial design: Prospective observational study

2. Target population: 200 NSCLC patients with histologically or cytologically confirmed stage IV or recurrent NSCLC who have progressive disease after 1st line chemotherapy who consent for study participation and meet the study selection criteria

3. Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib

- C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR

4. We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )

5. Duration of Trial Recruitment: 2 years
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- Informed consent

- 19~80 year old male or female

- Histologically proven advanced or metastatic NSCLC

- Failed to 1st line chemotherapy

- Tumor tissue for genetic analysis

- Evaluable target lesion by RECIST v1.1

- ECOG performance from 0 to 3

- Expected survival more than 12 weeks

Exclusion Criteria:

- Previous treatment of EGFR-tyrosine kinase inhibitors

- Severe hypersensitivity to erlotinib

- Residual toxicities (above grade 2) after previous chemotherapy

- Total bilirubin more than 1.5x of upper normal limit Liver function tests more than 2.5x of upper normal limits
Location
Chonnam National University Hwasun Hospital
Jeonnam, Korea, Republic of
Status: Recruiting
Contact: Young-Chul Kim, MD, PhD - +82-61-379-7614 - kyc0923@chonnam.ac.kr
Start Date
December 2011
Completion Date
December 2015
Sponsors
Chonnam National University Hospital
Source
Chonnam National University Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page