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

Completed

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

• Registration Number: NCT01523340
• Lead Sponsor: Chonnam National University Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-28
• Study First Posted: 2012-02-01
• Primary Completion: 2014-09
• Study Completion: 2017-11
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rates of C-met expression/amplification and EGFR gene mutations	Average of 1 year	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

Trial Locations

Locations (1)

Chonnam National University Hwasun Hospital; 🇰🇷 Hwasun, Korea, Republic of