EGFR Mutations on ctDNA in Patients With Advanced NSCLC

First People's Hospital of Hangzhou1,055 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,055

Conditions

Non-small Cell Lung Cancer Stage III Non-Small-Cell Lung Cancer Metastatic

Interventions

mutation detectionOTHER

ARMSOTHER

ctDNA analysisGENETIC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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;

Locations (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

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)

Time frame: up to 2 years

Secondary Outcomes

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

Time frame: up to 2 years

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)

Time frame: up to 2 years

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

Time frame: up to 2 years

Data from ClinicalTrials.gov

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