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.
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
Being treated with definitive chemoradiotherapy or surgery
Receiving treatment for advanced lung cancer for over one month before enrollment; OR
Parallel
Best Practice
Other interventionReceive usual care
Biospecimen Collection
Procedure/SurgeryUndergo collection of tumor tissue and blood sample for repository
Biospecimen Collection
Procedure/SurgeryUndergo tumor tissue and blood sample for AGIT/DS
Laboratory Biomarker Analysis
Other interventionCorrelative studies
Medical Chart Review
Other interventionUndergo medical record abstraction
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Smoking Cessation Intervention
BehavioralUndergo usual care or NCCN-driven CTC/DS
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.
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.
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).
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).
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