Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

• Conditions: Bronchial Neoplasms; Carcinoma, Bronchogenic; Lung Diseases; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

• Registration Number: NCT02804100
• Lead Sponsor: Wenzhou Medical University

Brief Summary

A multi-centre observational, non-interventional study is to dynamically monitor the changes of circulating tumor DNA (ctDNA) in late stage NSCLC patients under Gefitinib treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Provision of informed consent
• Histologically confirmed stage IIIB/IV NSCLC.
• Activating EGFR mutations (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q)
• Able to comply with the required protocol and followed-up procedures, and able to receive oral medications

Exclusion Criteria

• Histologically confirmed small cell lung cancer or other metastatic tumors
• Patient had received prior chemotherapy or EGFR-TKIs treatment
• Patients who harbor Exon20 T790M mutation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment	2 years

Trial Locations

Locations (1)

Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China