Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients with Stage IV Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. Establish a 6 month observation period for stage IV non-small cell lung cancer patients (NSCLC) (n=400), using the statewide research network, documenting usual care (UC) practices, survival and quality of life.

II. Following the 6 month observation period, conduct a 3 year clinical trial in stage IV NSCLC patients (n=2500) randomized to either UC or free advanced genomic and immunotherapy testing (AGIT) (next generation sequencing tumor or blood circulating tumor deoxyribonucleic acid (DNA) and PD-L1 testing immunohistochemistry staining) with decision support (DS) through a genomics board, followed by medical record review and recontacting of patients.

III. Following the aim 1 six month observation period, for subjects in aim 2 (n=375) who smoke or have recently quit smoking, and their household members who smoke (n=94), to conduct a 1 year smoking cessation intervention trial where subjects are randomized to UC or National Cancer Center Network (NCCN)-driven centralized telephone counseling and decision support (CTC/DS).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (UC): Patients receive usual care and undergo collection of tumor tissue and blood sample for the repository. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

ARM II (AGIT/DS): Patients undergo collection of tumor tissue for analysis using FoundationOne assay and blood sample for analysis using FoundationACT blood circulating tumor DNA assay. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

After completion of study, patients are followed up every month for 9 months and every 2 months for up to 3 years.