Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
N/A
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
EGFR Mutation Positive Non-small Cell Lung Cancer
Both
EGFR Mutation Positive Non-small Cell Lung Cancer
Trial Information
Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
detection of resistant gene
Outcome Description:
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
Outcome Time Frame:
24 months
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
2011-10-054
NCT ID:
NCT01776684
Start Date:
June 2012
Completion Date:
May 2015
Related Keywords:
- EGFR Mutation Positive Non-small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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