Non Small Cell Lung Cancer Metastatic, Non Small Cell Lung Cancer Recurrent
Conditions
Keywords
NSCLC, Cancer panel, NGS, Actionable mutation, Immune checkpoint inhibitor
Brief summary
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
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
Interventions
DIAGNOSTIC_TESTMACROGEN Pan Cancer Panel (Tier 2)
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.
Sponsors
MACROGEN
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 : 1. Cohort A: Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance rate | an average of one year | Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | an average of one year | To evaluate prognostic role of ctDNA concentration in NSCLC |
| Frequency of actionable genomic change | an average of one year | To determine the frequency of actionable oncogenic genes in NSCLC |
| Overall survival by treatment | an average of one year | To evaluate the survival of patients treated with genotype-directed therapy in daily practice |
Countries
South Korea
Outcome results
None listed