EGFR Mutation Detection From Advanced NSCLC Patient Tissue and Plasma in EGFR-TKI Treatment

GenoSaber100 enrolled

Overview

This study has been designed in order to detect EGFR mutation abundance of tissue and concentration of plasma from Advanced Non-small Cell Lung Cancer during treatment with Tyrosine Kinase Inhibitor (TKI) .Through this experiment the investigators aim to evaluate the feasibility of plasma EGFR detection and evaluate the correlation of EGFR mutations and prognosis.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Non-small Cell Lung Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age older than 18 years and under 75 years * Histologically and cytologically proven non-small Cell Lung Cancer * Clinical stages Ⅲ \~ Ⅳ * Not receive any anti-tumor treatment * Eastern cooperative oncology group performance status (ECOG PS) =1\~2 * Estimated survival time more than 3 months * EGFR-TKI treatment for first-line or second-line * Voluntary to participate in this clinical trial and sign the consent form Exclusion Criteria: * Patients have received EGFR-TKI therapy before the study * With other malignancy history in the recent 5 years before the study * Pregnancy or breast feeding phase * Inadequate samples for testing * Follow-up compliance is poor

Outcomes

Primary Outcomes

EGFR Mutation Detection of FFPE and plasma samples

To evaluate the feasibility of plasma EGFR detection from non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs and evaluate the correlation of EGFR mutations and prognosis.

Time frame: baseline

EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.

In order to monitor the change of plasma EGFR mutation copy number.

Time frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.