EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Completed

• Conditions: Non-small Cell Lung Cancer Stage III; Non-Small-Cell Lung Cancer Metastatic

• Registration Number: NCT02623257
• Lead Sponsor: First People's Hospital of Hangzhou

Brief Summary

The study aims to explore the prevalence of EGFR mutations assessed with ctDNA samples in advanced NSCLC, who had received ≤ 1 prior systemic chemotherapy regimens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-04
• Study First Posted: 2015-12-07
• Study Start: 2016-01
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-02-12
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1055

Inclusion Criteria

• Histologically confirmed stage IIIB/IV NSCLC;
• Patient had received ≤ 1 prior systemic chemotherapy regimens;
• Provision of blood (plasma) sample for ctDNA testing;
• Patient must be able to comply with the protocol;

Exclusion Criteria

• Prior received ≥2 systemic chemotherapy regimens;
• As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease);
• Histologically confirmed small cell lung cancer or other metastatic tumors;
• Patient with no histologic or cytological diagnosis;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	up to 2 years	The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)

Secondary Outcome Measures

Name	Time	Method
Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics	up to 2 years	The investigators will employ chi-square test to analyze the distribution of EGFR mutation by ARMS in NSCLC patients among the different characteristics including smoking status, gender, age, PS score, and tumor stage
Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	up to 2 years	The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in non-small cell lung cancer (NSCLC) patients after first-line chemotherapy failure
Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	up to 2 years	The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in treatment-naive patients with non-small cell lung cancer (NSCLC)

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China