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NCT Number: NCT03199651

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

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.

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Key information

Conditions

Cigarette Smoker Adenocarcinoma Adenocarcinoma of Lung Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Current Smoker Lung Adenocarcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Squamous Cell Lung Carcinoma Stage IV Non-small Cell Lung Cancer Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Peter G. Shields, MD

CONTACT

[email protected]

614-688-6563

Peter G. Shields, MD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

1a. Establish a 3 month observation period for newly diagnosed stage IV non-small cell lung cancer patients (NSCLC)(n=300), using the statewide research network, documenting usual care (UC) practices, survival and quality of life and patients previously diagnosed with stage IV NSCLC within one year prior to initiating the study, (n=300).

1b. Establish a cohort of newly diagnosed stage IV non-small cell lung cancer patients (NSCLC), documenting usual care (UC) practices, survival and quality of life and patients previously diagnosed with stage IV NSCLC within one year prior to initiating the study, (n=800). This cohort will be limited to subjects directly recruited from Ohio State University for the duration of the study.

  • Following the 3 month observation period, conduct a two-phase, cluster-randomized 21 month clinical trial in stage IV NSCLC patients (n=2100).

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).

  • Following the Aim 1 three month observation period, for subjects enrolled in Aim 2 (both phases) who smoke or have recently quit smoking (n=336), and their household members who smoke (n=84), to conduct a 1 year smoking cessation intervention trial where subjects are randomized by site to receive UC or National Cancer Center Network (NCCN)-driven centralized telephone counseling and decision support (CTC/DS).
  • Separately, we will identify epigenetic biomarkers as prognostic and predictive biomarkers and analyze immune profile as biomarkers for immune-related adverse events. Assays will be performed using samples and data from subjects who consent to the repository.

4a. We will identify tumor epigenetic biomarkers (DNA methylation by Illumina methylation profiling) for immunotherapy (IOT) response in stage IV NSCLC (n=50 participants each with PD-L1 expression <1% and >50%) and extend the results to the study of blood cell-free DNA (cfDNA).

4b. We will identify immune profile using blood transcriptomics as biomarkers for IOT Immune-Related Adverse Events (irAE) (n=50).

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Biospecimen Collection

Procedure

Undergo collection of tumor tissue and blood sample for repository

laboratory biomarker analysis

Other

Correlative studies

medical chart review

Other

Undergo medical record abstraction

Other names: Chart Review

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Ancillary studies

Smoking Cessation Intervention

Behavioral

Undergo usual care or NCCN-driven CTC/DS

Other names: Smoking and Tobacco Use Cessation Interventions

Primary outcomes

  1. Cost-Effectiveness Analysis

    Time frame: Up 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.

  2. Overall survival (Aim I observational phase)

    Time frame: 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.

  3. Percent of patients receiving first line targeted therapy (Aim I observational phase)

    Time frame: 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).

  4. Percent of patients receiving genomic testing at diagnosis and type of genomic testing (Aim I observational phase)

    Time frame: 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).

  5. Percent of patients receiving genomic testing later in treatment (Aim I observational phase)

    Time frame: 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).

  6. Percent of patients receiving off label therapy (Aim I observational phase)

    Time frame: 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).

  7. Percent of patients referred to clinical trials (Aim I observational phase)

    Time frame: 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.

  8. Percent of patients who enroll in therapeutic clinical trials (Aim I observational phase)

    Time frame: 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).

  9. Progression free survival (Aim I observational phase)

    Time frame: 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.

  10. Quality of life assessed using European Organization for Research and Treatment-quality of life questionnaire

    Time frame: Up 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

  11. Smoking cessation (Aim III centralized telephone counseling/decision support)

    Time frame: 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.

  12. Survival (Aim 2 advanced genomic and immunotherapy testing/decision support)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Reisinger

CONTACT

[email protected]

614-366-4542

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Beating Lung Cancer in Ohio (BLCIO) Protocol

Acronym: BLCIO

Important dates

Study start
2017
Primary completion
2026
Study completion
2028
First posted
Jun 27, 2017
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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