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

This study is currently recruiting participants.
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

January 5, 2012
January 30, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01523340 on ClinicalTrials.gov Archive Site
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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
  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
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

NSCLC tumor tissue for c-MET expression by immuohistochemistry c-MET amplification by silver in situ hybridization EGFR mutation by realtime PCR

Non-Probability Sample

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

  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Recurrent
Not Provided
Erlotinib treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
19 Years to 80 Years
No
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
Korea, Republic of
 
NCT01523340
MENTOR_2011
Yes
Young-Chul Kim, Chonnam National University Hospital
Chonnam National University Hospital
Roche Pharma AG
Principal Investigator: Young-Chul Kim, MD, PhD Chonnam National University Hospital
Chonnam National University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP