Overview

Conditions carcinoma, non-small-cell lung, bronchial neoplasms, carcinoma, bronchogenic, lung diseases, lung neoplasms
Sponsor Wenzhou Medical University
Start date May 2016
End date December 2017
Trial size 200 participants
Trial identifier NCT02804100, 4241616009G

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.

Recruiting in the following locations…

United States No locations recruiting
Other Countries China

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
dynamic changes of circulating tumor DNA in late stage NSCLC patients under Gefitinib treatment
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Multi-centre Observational Study on Dynamic Changes of Circulating Tumor DNA in Late Stage NSCLC Patients Under Gefitinib Treatment
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Wenzhou Medical University.