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Trial Title:
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
NCT ID:
NCT01776684
Condition:
EGFR Mutation Positive Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Erlotinib Hydrochloride
Gefitinib
Afatinib
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
Arm group label:
EGFR positive arm
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Myung-Ju Ahn, M.D., Ph.D.
Email:
silkahn@skku.edu
Start date:
June 2012
Completion date:
May 2015
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01776684