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

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ClinicalTrials.gov Identifier: NCT01523340
Recruitment Status : Unknown
Verified January 2013 by Young-Chul Kim, Chonnam National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 1, 2012
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Young-Chul Kim, 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

Condition or disease
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer Recurrent

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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
Study Start Date : December 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Erlotinib treatment



Primary Outcome Measures :
  1. 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



Biospecimen Retention:   Samples Without DNA
NSCLC tumor tissue for c-MET expression by immuohistochemistry c-MET amplification by silver in situ hybridization EGFR mutation by realtime PCR


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01523340


Contacts
Contact: Young-Chul Kim, MD, PhD +82-61-379-7614 kyc0923@chonnam.ac.kr
Contact: In-Jae Oh, MD, PhD +82-61-379-7617 droij@chonnam.ac.kr

Locations
Korea, Republic of
Chonnam National University Hwasun Hospital Recruiting
Jeonnam, Korea, Republic of, 519-763
Contact: Young-Chul Kim, MD, PhD    +82-61-379-7614    kyc0923@chonnam.ac.kr   
Contact: In-Jae Oh, MD, PhD    +82-61-379-7617    droij@chonnam.ac.kr   
Principal Investigator: Young-Chul Kim, MD, PhD         
Sub-Investigator: In-Jae Oh, MD, PhD         
Sub-Investigator: Yoo-Duk Choi, MD, PhD         
Sub-Investigator: Hee-Jung Ban, MD, PhD         
Sponsors and Collaborators
Chonnam National University Hospital
Roche Pharma AG
Investigators
Principal Investigator: Young-Chul Kim, MD, PhD Chonnam National University Hospital

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01523340     History of Changes
Other Study ID Numbers: MENTOR_2011
First Posted: February 1, 2012    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action