Improving survival in patients with advanced lung cancer in Ohio

Beating Lung Cancer in Ohio (BLCIO) Protocol

This study is testing a new approach to help people with advanced lung cancer in Ohio live longer and feel better by using advanced genetic and immune system tests to guide their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 3584 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ohio State University Comprehensive Cancer Center (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Columbus, Ohio)
• Trial ID: NCT03199651 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the Beating Lung Cancer in Ohio protocol aimed at improving survival rates for patients with stage IV non-small cell lung cancer (NSCLC). It involves a three-month observation period for newly diagnosed patients, followed by a two-phase, cluster-randomized trial assessing the impact of advanced genomic and immunotherapy testing on treatment outcomes. The study will document usual care practices, survival rates, and quality of life for participants, with a focus on providing decision support through a genomics board. The trial aims to recruit a total of 2100 patients across various sites in Ohio.

Who should consider this trial

Good fit: Ideal candidates include English-speaking patients with pathologically confirmed stage IV NSCLC who are current smokers or recent quitters.

Not a fit: Patients with early-stage lung cancer or those who do not meet the smoking criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and quality of life for patients with stage IV non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise in using genomic and immunotherapy approaches for lung cancer, suggesting potential success for this trial.

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

Where this trial is running

Columbus, Ohio

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Peter Shields, MD — Ohio State University Comprehensive Cancer Center
• Study coordinator: The Ohio State University Comprehensive Cancer Center

Conditions: Cigarette Smoker, Current Smoker, Lung Adenocarcinoma, Squamous Cell Lung Carcinoma, Stage IV Non-Small Cell Lung Cancer