PRIMARY OBJECTIVES:
I. To determine if CSF-ctDNA positivity in patients with locally advanced lung cancer can predict the presence of brain metastases within a one year period.
II. To prospectively confirm that cerebrospinal fluid (CSF) circulating tumor DNA (ctDNA) can be detected in patients diagnosed with metastatic non-small cell lung cancer (NSCLC) to the brain utilizing next generation sequencing (NGS) and single gene quantitative/biomarker analyses through the CNSide (trademark) platform.
SECONDARY OBJECTIVES:
I. To use the CNSide (trademark) platform to assess for the presence of circulating tumor cells in both CSF and peripheral blood.
II. To compare the NGS profile of the ct-DNA in the CSF with matched peripheral blood samples.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1 (STAGE III/IV NSCLC WITHOUT BRAIN METASTASES): Patients undergo lumbar puncture (LP) for collection of CSF and blood sample collection after completion of chemoradiotherapy (stage III) or after diagnosis (stage IV) on study. Patients also undergo magnetic resonance imaging (MRI) during screening and 12 month follow-up.
COHORT 2 (STAGE IV NSCLC WITH BRAIN METASTASES): Patients undergo LP for collection of CSF and blood sample collection on study. Patients also undergo MRI during screening.
Patients with CSF negative for ctDNA at the first LP draw, undergo an additional LP draw at 6 months. Patients with CSF positive for ctDNA at the first LP draw, may not undergo an additional LP at 6 months.
Patients without brain metastases are followed for 12 months. Patients with brain metastases are followed for 6 months.
