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.

Inclusion Criteria:

- AIM 1-3

- Pathologically confirmed stage IV NSCLC (with any Eastern Cooperative Oncology Group
[ECOG] performance status, and any NSCLC - adenocarcinoma, squamous cell, etc.) with
available imaging OR patients who do not yet have their staging completed, but in the
judgment of the physician are likely to be stage IV;

- Patients may be enrolled if the recruiter cannot reach the patient by the first
office visit, preferably prior to starting therapy and no later than one month
after starting therapy; (NCCN guidelines allow for a switch to targeted therapy
from chemotherapy if testing comes back positive after starting chemotherapy)

- English speaking; and

- Willing to provide access to medical records, insurance and billing data, biospecimens
and respond to questionnaires, typically by phone, but possibly to include online or
in-person surveys

- AIM 3 ONLY

- Patients must be current smokers who smoke at least one cigarette most days per week,
or recent quitters who smoked at least one cigarette most days per week (< 3 months);
and

- Household members must be current smokers, defined as smoking at least one cigarette
most days per week

- Hearing and vision impairments that would prevent ability to complete consent,
interviews, or sample collection

Exclusion Criteria:

- Being treated with definitive chemoradiotherapy or surgery

- Receiving treatment for advanced lung cancer for over one month before enrollment; OR