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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Chonnam National University Hospital
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Young-Chul Kim, Chonnam National University Hospital
ClinicalTrials.gov Identifier:
NCT01523340
First received: January 5, 2012
Last updated: January 30, 2013
Last verified: January 2013
  Purpose
  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
Non-small Cell Lung Cancer Metastatic
Non-small Cell Lung Cancer Recurrent

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Chonnam National University Hospital:

Primary Outcome Measures:
  • The rates of C-met expression/amplification and EGFR gene mutations [ Time Frame: Average of 1 year ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Erlotinib treatment

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Young-Chul Kim, Professor, Chonnam National University Hospital
ClinicalTrials.gov Identifier: NCT01523340     History of Changes
Other Study ID Numbers: MENTOR_2011
Study First Received: January 5, 2012
Last Updated: January 30, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on November 25, 2014