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

August 1, 2021 updated by: Young-Chul Kim, Chonnam National University Hospital

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

  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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Hwasun, Korea, Republic of, 58128
        • Chonnam National University Hwasun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Erlotinib treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chonnam National University Hospital

Collaborators

Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 28, 2012

First Posted (ESTIMATE)

February 1, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MENTOR_2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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