Cancer Panel From Blood of Lung Cancer Patients (CAPABLE)

Seoul National University

Status: Unknown

Conditions: Non Small Cell Lung Cancer Metastatic; Non Small Cell Lung Cancer Recurrent

Treatments: Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)

Study type: Observational

Funder types: Other

Identifiers

NCT03235765

SNUBH-17-01

Details and patient eligibility

About

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).

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Cohort A

Description:

Patients who are diagnosed with metastatic/recurrent non-small cell lung cancer and planned to receive first line chemotherapy

Treatment:

Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)

Cohort B

Description:

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.

Treatment:

Diagnostic Test: MACROGEN Pan Cancer Panel (Tier 2)