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

Non-small Cell Lung Cancer Metastatic Clinical Trial

— MENTOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01523340
• Other study ID #: MENTOR_2011
• Status: Completed
• Start date: September 2011
• Est. completion date: November 2017

Study information

• Verified date: August 2021
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: November 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Metastatic
• Non-small Cell Lung Cancer Recurrent

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Roche Pharma AG

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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