Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01776684

Enrollment

200

Registered

2013-01-28

Start date

2012-06-30

Completion date

2015-05-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR Mutation Positive Non-small Cell Lung Cancer

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.

Interventions

DRUGEGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactMyung-Ju Ahn, M.D., Ph.D.

silkahn@skku.edu

Backup ContactJong-Mu Sun, M.D., Ph.D.

tntntn3@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026