Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Samsung Medical Center200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer

Interventions

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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 Exclusion Criteria: * 1\. Active infection 2. Active bleeding

Locations (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

detection of resistant gene

To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs

Time frame: 24 months

Central Contacts

Myung-Ju Ahn, M.D., Ph.D.

CONTACT

silkahn@skku.edu

Jong-Mu Sun, M.D., Ph.D.

CONTACT

tntntn3@gmail.com

Data from ClinicalTrials.gov

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