Recruiting

Lung Cancer

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT03199651

Conditions

Cigarette Smoker

Current Smoker

Lung Adenocarcinoma

Squamous Cell Lung Carcinoma

Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Biospecimen Collection

Biospecimen Collection

Laboratory Biomarker Analysis

Medical Chart Review

Study Details

Brief 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 than conventional chemotherapy and impact quality of life.

Conditions

Cigarette Smoker

Current Smoker

Lung Adenocarcinoma

Squamous Cell Lung Carcinoma

Stage IV Non-Small Cell Lung Cancer

Study ID

NCT03199651

Start date

Jul 17, 2017

Status verified date

Feb, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3584 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

Best Practice

Receive usual care

Biospecimen Collection

Undergo collection of tumor tissue and blood sample for repository

Biospecimen Collection

Undergo tumor tissue and blood sample for AGIT/DS

Laboratory Biomarker Analysis

Correlative studies

Medical Chart Review

Undergo medical record abstraction

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Smoking Cessation Intervention

Undergo usual care or NCCN-driven CTC/DS

Primary outcome measure

  • Cost-Effectiveness Analysis [ Time Frame: Up to 24 months ]
  • Overall survival (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients receiving first line targeted therapy (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients receiving genomic testing at diagnosis and type of genomic testing (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients receiving genomic testing later in treatment (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients receiving off label therapy (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients referred to clinical trials (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Percent of patients who enroll in therapeutic clinical trials (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Progression free survival (Aim I observational phase) [ Time Frame: Up to 3 years ]
  • Quality of life assessed using European Organization for Research and Treatment-quality of life questionnaire [ Time Frame: Up to 24 months ]
  • Smoking cessation (Aim III centralized telephone counseling/decision support) [ Time Frame: Up to 6 months ]
  • Survival (Aim 2 advanced genomic and immunotherapy testing/decision support) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Sarah Reisinger

614-366-4542Sarah.Reisinger@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Peter G. Shields, MD

614-688-6563peter.shields@osumc.edu

Principal Investigator:

Peter G. Shields, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-17.