NCT01523340

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

Phase 4 Study of Response to EGFR-TKI and Correlation With C-met Expression and EGFR Gene Mutation in NSCLC Patients Treated With Erlotinib

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Chonnam National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2017-11-01
• First posted: 2012-02-01
• Last updated: 2021-08-03

Locations

1 site across 1 country: South Korea