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

Non-small Cell Lung Cancer Clinical Trial

Official title:

Epidermal Growth Factor Receptor (EGFR) Mutation Detection From Advanced Non-small Cell Lung Cancer Tissue and Plasma in Tyrosine Kinase Inhibitor (TKI) Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02644889
• Other study ID #: EGFR2015-02
• Status: Not yet recruiting
• Phase: N/A
• First received: December 28, 2015
• Last updated: January 6, 2016
• Start date: January 2016

Study information

• Verified date: November 2015
• Source: GenoSaber
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age older than 18 years and under 75 years

• Histologically and cytologically proven non-small Cell Lung Cancer

• Clinical stages ? ~ ?

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GenoSaber

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline	No
Primary	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.	From start of treatment to time of progression or death, whichever occurs first, assessed up to 3 years	No