Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-05-31

Brief Summary

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To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.

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Detailed Description

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Conditions

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EGFR Mutation Positive Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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EGFR positive arm

Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)

Group Type EXPERIMENTAL

EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Intervention Type DRUG

Interventions

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EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent