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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01523340

Acronym

MENTOR

Enrollment

196

Registered

2012-02-01

Start date

2011-09-30

Completion date

2017-11-30

Last updated

2021-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The rates of C-met expression/amplification and EGFR gene mutations	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

Countries

South Korea

Outcome results