EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

A Diagnostic Study to Determine the Prevalence of Epidermal Growth Factor Receptor Mutations Assessed With Circulating Tumor DNA Samples in Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02623257
• Other study ID #: 20154701
• Status: Completed
• Phase: N/A
• First received: December 3, 2015
• Last updated: February 12, 2018
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1055
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III
• Non-Small-Cell Lung Cancer Metastatic

Intervention

Other:
• mutation detection

• ARMS

Genetic:
• ctDNA analysis

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	The investigators will describe the proportion of EGFR mutation on ctDNA detected by ARMS assay in patients with non-small cell lung cancer (NSCLC)	up to 2 years
Secondary	Distribution of EGFR mutation by ARMS assays among the different Clinical characteristics	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	up to 2 years
Secondary	Proportion of treatment-naive patients with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	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)	up to 2 years
Secondary	Proportion of patients after first-line chemotherapy failure with EGFR mutation detected by amplification refractory mutation system (ARMS) assay	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	up to 2 years