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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

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