Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- GenoSaber
- Enrollment
- 100
- Primary Endpoint
- EGFR Mutation Detection of plasma samples for the following-up patients who take TKI.
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 plasma samples for the following-up patients who take TKI.
Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years
In order to monitor the change of plasma EGFR mutation copy number.
EGFR Mutation Detection of FFPE and plasma samples
Time Frame: baseline
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.