Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

Samsung Medical Center

Status: Unknown

Conditions: EGFR Mutation Positive Non-small Cell Lung Cancer

Treatments: Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01776684

2011-10-054

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

EGFR positive arm

Experimental group

Description:

Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)

Treatment:

Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)