Back to resultsEvaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
Primary Purpose
EGFR Mutation Positive Non-small Cell Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
Sponsored by
About this trial
This is an interventional diagnostic trial for EGFR Mutation Positive Non-small Cell Lung Cancer
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EGFR positive arm
Arm Description
Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01776684
First Posted
January 23, 2013
Last Updated
January 25, 2013
Sponsor
Samsung Medical Center
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01776684
Brief Title
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EGFR Mutation Positive Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EGFR positive arm
Arm Type
Experimental
Arm Description
Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
Intervention Type
Drug
Intervention Name(s)
EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
Primary Outcome Measure Information:
Title
detection of resistant gene
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
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, M.D., Ph.D.
Email
silkahn@skku.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jong-Mu Sun, M.D., Ph.D.
Email
tntntn3@gmail.com
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, M.D., Ph.D.
Email
silkahn@skku.edu
12. IPD Sharing Statement
Learn more about this trial
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
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