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

NCT01523340 | Completed DMC

• 1 other identifier: MENTOR_2011
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Trial design: Prospective observational study
2. 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. 3.Primary objective: To investigate C-met expression/amplification and EGFR gene mutations in NSCLC patients treated with Erlotinib
4. 4.C-met expression by IHC C-met amplification by SISH EGFR mutation by real time PCR
5. 5.We will also assess the correlation of EGFR mutations and c-MET with clinical outcome (Overall Response Rate, Progression Free survival )
6. 6.Duration of Trial Recruitment: 2 years

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Erlotinib treatment

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Informed consent
• \~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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

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

Study Officials

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: February 1, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2017
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

KR (1)