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Beating Lung Cancer in Ohio Protocol for Stage IV Non-Small Cell Lung Cancer

This study, called the Beating Lung Cancer in Ohio Protocol, is looking at ways to improve survival for people with stage IV non-small cell lung cancer (NSCLC). It aims to understand how current care practices affect survival and quality of life. The study will also evaluate if advanced genomic and immunotherapy testing (AGIT), which looks for specific biomarkers like PD-L1 to guide treatment with immunotherapies and targeted therapies, can lead to better outcomes than usual care. Researchers will compare the cost-effectiveness and overall survival of these approaches. You may be eligible if you are an adult with stage IV NSCLC, including those who smoke or have smoked.

Study design
This study plans to enroll 3584 participants. It involves an initial observation period followed by a two-phase, cluster-randomized clinical trial where sites will either offer usual care or advanced genomic and immunotherapy testing.
What's involved
Participants may undergo collection of tumor tissue and blood samples, medical chart review, and receive usual care or advanced genomic and immunotherapy testing. The observation phase lasts 3 months, and the clinical trial phase lasts 21 months.
Compensation
Not stated in the trial record.
Follow-up
Overall survival will be measured for up to 3 years. Cost-effectiveness analysis will be measured for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03199651

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

Recruiting
NAAges 18+InterventionalHealth services
Ohio State University Comprehensive Cancer Center
~3,584 participants
Updated 2026-06-17 on ClinicalTrials.gov
What's tested:Best PracticeBiospecimen CollectionLaboratory Biomarker AnalysisMedical Chart ReviewQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cost-Effectiveness Analysis
Measured over Up to 24 months
+11 more outcomes measured

Conditions

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Peter Shields, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Eligibility criteria

Inclusion

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

Being treated with definitive chemoradiotherapy or surgery
Receiving treatment for advanced lung cancer for over one month before enrollment; OR

What this trial measures

  • Cost-Effectiveness AnalysisUp to 24 months

    Using the payer perspective, Incremental Cost-Effectiveness Ratio (ICER) will be calculated based on estimates of overall survival/health care resource costs associated with treatment and the EQ5D questionnaire.

  • Overall survival (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves) and Kaplan-Meier plots to display survival curves.

  • Percent of patients receiving first line targeted therapy (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves).

  • Percent of patients receiving genomic testing at diagnosis and type of genomic testing (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves).

  • Percent of patients receiving genomic testing later in treatment (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves).

  • Percent of patients receiving off label therapy (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves).

  • Percent of patients referred to clinical trials (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves) and Kaplan-Meier plots to display survival curves.

  • Percent of patients who enroll in therapeutic clinical trials (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves).

  • Progression free survival (Aim I observational phase)Up to 3 years

    Descriptive statistics (summaries, distributions, 95% confidence intervals) will be reported and compared with the two arms in the randomized trial phase. Graphical displays will be used to show distributions (boxplots, density curves) and Kaplan-Meier plots to display survival curves.

  • Quality of life assessed using European Organization for Research and Treatment-quality of life questionnaireUp to 24 months

    For aim II, a linear mixed model will be used to model change in quality of life as subjects are transitioned from one therapy to the next, with a main effect for treatment group and random effect for hospital and patient nested within hospital. To allow for possible changes in trajectories over time (e.g., a change-point analysis) the 'segmented' package in R will be used. Trajectories for each treatment will be modeled using a segmented mixed model with random change points as implemented in R. Variables associated with missing values will be evaluated and potentially included in the mixed m

  • Smoking cessation (Aim III centralized telephone counseling/decision support)Up to 6 months

    Primary analysis will focus on smoking cessation at six months follow-up using generalized linear mixed models with a random effect for practice. The odds ratio and 95% confidence interval between smoking cessation and intervention arm will be reported based on the generalized linear mixed models model. As an alternative, we will also fit competing risks regression models (e.g., using the R package 'cmprsk') with death and smoking cessation as competing events. Subdistribution function hazard ratios for smoking cessation based on the intervention will be reported.

  • Survival (Aim 2 advanced genomic and immunotherapy testing/decision support)Up to 3 years

    Overall differences in survival between the advanced genomic and immunotherapy testing and usual care arms will be assessed using the log-rank test. Cox proportional hazards model will be fit with a random effect for hospital and time to obtain the hazard ratio and 95% confidence interval for the treatment effect (advanced genomic and immunotherapy testing versus usual care). Interaction between treatment and time (e.g., via a time-dependent treatment effect) will be evaluated to assess possible evolution in usual care over time. To assess clinical decision making and clinical trial referral.