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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2017-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Erlotinib treatment

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No