Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
Not Applicable
- Conditions
- EGFR Mutation Positive Non-small Cell Lung Cancer
- Interventions
- Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
- Registration Number
- NCT01776684
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
-
- 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
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Exclusion Criteria
-
- Active infection 2. Active bleeding
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EGFR positive arm EGFR TKIs (gefitinib, erlotinib, afatinib, et al) Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
- Primary Outcome Measures
Name Time Method detection of resistant gene 24 months 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of