Cancer Panel From Blood of Lung Cancer Patients

Study Overview
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Brief Summary
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Molecular profiling of lung cancers using circulating tumor DNA (ctDNA) in the blood of patients is rapidly becoming established as a useful source of information to aid clinical decision-making. This study is aimed to to compare concordance rate between tissue based cancer panel analysis and blood based cancer panel analysis in lung cancer patients (both by NGS technique).

Detailed Description
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This study is comprised of two cohorts as below: Cohort A: inoperable, untreated, non-small cell lung cancer patients Cohort B: non-small cell lung cancer patients who are in the treatment with targeted agents including immune checkpoint inhibitors

Official Title
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Clinical Validity of Oncogenic Driver Genes Detected From Circulating Tumor DNA in Blood of Lung Cancer Patients

Conditions
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Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent

Intervention / Treatment
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* Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures, sampling, and analyses Pathologically confirmed non-small cell lung cancer Male or female, aged at least 20 years Matches one of two criteria : Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy Cohort B: Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent. Exclusion Criteria: Any concurrent and/or other active malignancy that has required treatment within 3 years Patients with mixed small cell histology Life expectancy less than 3 months Insufficient tissue for NGS test

Ages Eligible for Study
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Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy | Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)<br>* This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.<br>|
| Cohort B<br>Patients with recurrent/metastatic non-small cell lung cancer who have been receiving molecular targeted therapy, including immune checkpoint inhibitor, and have tumor shrinkage with the agent. | Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)<br>* This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance rate | Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA | an average of one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | To evaluate prognostic role of ctDNA concentration in NSCLC | an average of one year | 
| Frequency of actionable genomic change | To determine the frequency of actionable oncogenic genes in NSCLC | an average of one year | 
| Overall survival by treatment | To evaluate the survival of patients treated with genotype-directed therapy in daily practice | an average of one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Cancer panel, NGS, Actionable mutation, Immune checkpoint inhibitor