Cancer Panel From Blood of Lung Cancer Patients

• Conditions: Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Recurrent
• Interventions: Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)

• Registration Number: NCT03235765
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2017-03-10
• Study First Submitted: 2017-07-28
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22
• Primary Completion: 2019-03-10
• Study Completion: 2020-03-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort B	MACROGEN Pan Cancer Panel (Tier 2)	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.
Cohort A	MACROGEN Pan Cancer Panel (Tier 2)	Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy

Primary Outcome Measures

Name	Time	Method
Concordance rate	an average of one year	Concordance rate of genomic change between tumor tissue (FFPE) and ctDNA

Secondary Outcome Measures

Name	Time	Method
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
Overall survival	an average of one year	To evaluate prognostic role of ctDNA concentration in NSCLC

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of