Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer

Summary: This randomized clinical trial studies the Beating Lung Cancer in Ohio protocol in improving survival in patients with stage IV non-small cell lung cancer. The Beating Lung Cancer in Ohio protocol may help in evaluating immunotherapies and targeted therapies that prolong survival, have more favorable toxicity profiles than conventional chemotherapy and impact quality of life.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant