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

Beating Lung Cancer in Ohio (BLCIO) Protocol

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 9 months, 12 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Phase 1: Over 9 months, sites will be randomized to offer patients either UC (70% of sites) or free advanced genomic and immunotherapy testing (AGIT) (next generation sequencing tumor or blood circulating tumor DNA and PD-L1 testing immunohistochemistry staining, 30% of sites), followed by medical record review and recontacting of patients, (n=900)."
  • "Phase 2: Over 12 months, sites will be randomized to offer patients AGIT or AGIT with decision support (DS) through a genomics board, followed by medical record review and recontacting of patients, (n=1200). 3\."
  • "ARM I (UC): Patients receive usual care and undergo collection of tumor tissue and blood sample for the repository."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (1)

OH