Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients

Overview

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.

Full Title of Study: “A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2017

Clinical Trial Outcome Measures

Primary Measures

  • dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Wenzhou Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chunming Ding, Professor – Wenzhou Medical University
  • Overall Official(s)
    • Wenfeng Li, Ph.D, Study Chair, First Affiliated Hospital of Wenzhou Medical University
  • Overall Contact(s)
    • Chunming Ding, Ph.D, 86-755-86690871, cmdingchina@qq.com

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