A Prospective Observational Study Evaluating c-MET Expression and EGFR Gene Mutation Correlation With Erlotinib Response

Chonnam National University Hospital196 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

196

Conditions

Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Recurrent

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The rates of C-met expression/amplification and EGFR gene mutations

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

Time frame: Average of 1 year