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

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

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Key information

Conditions

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

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Chonnam National University Hospital

Other

Collaborators

Roche Pharma AG

Registry information

Official study title

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

Acronym: MENTOR

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2017
First posted: Feb 1, 2012
Registry last updated: Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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