EGFR Mutations on ctDNA in Patients With Advanced NSCLC

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Other: mutation detection
* Other: ARMS
* Genetic: ctDNA analysis


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: mutation detection|nan|
|Other: ARMS|nan|
|Genetic: ctDNA analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer, circulating tumor DNA, amplification refractory mutation system