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Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Samsung Medical Center.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center Identifier:
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013
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.

Condition Intervention
EGFR Mutation Positive Non-small Cell Lung Cancer
Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • detection of resistant gene [ Time Frame: 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

Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGFR positive arm
Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01776684

Contact: Myung-Ju Ahn, M.D., Ph.D.
Contact: Jong-Mu Sun, M.D., Ph.D.

Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, M.D., Ph.D.   
Sponsors and Collaborators
Samsung Medical Center
  More Information

Responsible Party: Myung-Ju Ahn, M.D., Professor, Samsung Medical Center Identifier: NCT01776684     History of Changes
Other Study ID Numbers: 2011-10-054
Study First Received: January 23, 2013
Last Updated: January 25, 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017