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Cigarette SmokerBLCIONCT03199651

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

A study testing Best Practice, Biospecimen Collection and Laboratory Biomarker Analysis in people with Cigarette Smoker and Current Smoker, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Best Practice, Biospecimen Collection and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,584 participants
Where
1 siteUnited States
Study dates
17 Jul 2017to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State University Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Sarah Reisinger contact

614-366-4542

Sarah.Reisinger@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Peter G. Shields, MD, 614-688-6563, peter.shields@osumc.edu

    Peter G. Shields, MD

    Recruiting

Other trials in United States

About this study

Official title: Beating Lung Cancer in Ohio (BLCIO) Protocol

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.

Read the detailed description

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.

  1. 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).

  1. 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).
  2. 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.

Being tested
Best Practice, Biospecimen Collection, Laboratory Biomarker Analysis, Medical Chart Review, Quality-of-Life Assessment
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual care

  • Biospecimen CollectionProcedure or surgery

    Undergo collection of tumor tissue and blood sample for repository

  • Biospecimen CollectionProcedure or surgery

    Undergo tumor tissue and blood sample for AGIT/DS

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Medical Chart ReviewOther

    Also called Chart Review

    Undergo medical record abstraction

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • Smoking Cessation InterventionBehavioural

    Also called Smoking and Tobacco Use Cessation Interventions

    Undergo usual care or NCCN-driven CTC/DS

Study groups in NCT03199651
Study groupRoleWhat they receive
Arm I (UC)Active comparatorPatients 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.
Receives: Other: Best Practice; Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention
Arm II (AGIT/DS)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Laboratory Biomarker Analysis; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost-Effectiveness Analysis

    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.

    Measured: Up to 24 months

  2. Overall survival (Aim I observational phase)

    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.

    Measured: Up to 3 years

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

    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).

    Measured: Up to 3 years

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

    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).

    Measured: Up to 3 years

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

    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).

    Measured: Up to 3 years

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

    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).

    Measured: Up to 3 years

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

    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.

    Measured: Up to 3 years

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

    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).

    Measured: Up to 3 years

  9. Progression free survival (Aim I observational phase)

    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.

    Measured: Up to 3 years

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

    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

    Measured: Up to 24 months

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

    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.

    Measured: Up to 6 months

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

    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.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2017
  2. Study start17 Jul 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,584 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03199651
Sponsor's protocol ID
OSU-17070
Other IDs
NCI-2017-00723
Acronym
BLCIO
Status last verified
Feb 2026
First submitted
26 May 2017
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Park KR, Shields PG, Myers JV, Reisinger SA, Andersen BL. Depression and Inflammation Predict Depression Trajectory of Non-Small Cell Lung Cancer Patients. Biopsychosoc Sci Med. 2025 Jul-Aug 01;87(6):397-404. doi: 10.1097/PSY.0000000000001379. Epub 2025 Jun 11.

    PubMed 40511978

  • Valentine TR, Park KR, Presley CJ, Shields PG, Andersen BL. Lung cancer patients' illness perceptions: Prognostic for psychological and physical health trajectories. Health Psychol. 2024 Dec;43(12):913-923. doi: 10.1037/hea0001416. Epub 2024 Sep 26.

    PubMed 39325429

  • Blevins TR, Lo SB, Coker CA, Arrato NA, Reisinger SA, Shields PG, Andersen BL. COVID-19 or Cancer Stress? Anxiety and Depressive Symptoms in Patients with Advanced Lung Cancer. Int J Behav Med. 2024 Apr;31(2):325-330. doi: 10.1007/s12529-023-10206-w. Epub 2023 Aug 18.

    PubMed 37594667

  • Andersen BL, Myers J, Blevins T, Park KR, Smith RM, Reisinger S, Carbone DP, Presley CJ, Shields PG, Carson WE. Depression in association with neutrophil-to-lymphocyte, platelet-to-lymphocyte, and advanced lung cancer inflammation index biomarkers predicting lung cancer survival. PLoS One. 2023 Feb 24;18(2):e0282206. doi: 10.1371/journal.pone.0282206. eCollection 2023.

    PubMed 36827396

  • Valentine TR, Presley CJ, Carbone DP, Shields PG, Andersen BL. Illness perception profiles and psychological and physical symptoms in newly diagnosed advanced non-small cell lung cancer. Health Psychol. 2022 Jun;41(6):379-388. doi: 10.1037/hea0001192.

    PubMed 35604701

  • Arrato NA, Lo SB, Coker CA, Covarrubias JJ, Blevins TR, Reisinger SA, Presley CJ, Shields PG, Andersen BL. Cancer Treatment During COVID-19: Resilience of Individuals With Advanced Non-Small Cell Lung Cancer Versus Community Controls. J Natl Compr Canc Netw. 2022 Feb;20(2):118-125. doi: 10.6004/jnccn.2021.7076.

    PubMed 35130505

  • Andersen BL, McElroy JP, Carbone DP, Presley CJ, Smith RM, Shields PG, Brock GN. Psychological Symptom Trajectories and Non-Small Cell Lung Cancer Survival: A Joint Model Analysis. Psychosom Med. 2022 Feb-Mar 01;84(2):215-223. doi: 10.1097/PSY.0000000000001027.

    PubMed 34629425

  • Andersen BL, Valentine TR, Lo SB, Carbone DP, Presley CJ, Shields PG. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. doi: 10.1016/j.lungcan.2019.11.015. Epub 2019 Nov 21.

    PubMed 31806360

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Biospecimen Collection and Laboratory Biomarker Analysis in people with Cigarette Smoker and Current Smoker, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost-Effectiveness Analysis (time frame: Up to 24 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03199651, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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