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

Chonnam National University

Status: Completed

Conditions: Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Recurrent

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01523340

MENTOR_2011

Details and patient eligibility

About

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

Enrollment: 196 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

196 participants in 1 patient group

Erlotinib treatment