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

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ClinicalTrials.gov Identifier: NCT03199651
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Peter Shields, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Cigarette Smoker Current Smoker Lung Adenocarcinoma Squamous Cell Lung Carcinoma Stage IV Non-Small Cell Lung Cancer 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 Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Establish a 6 month observation period for stage IV non-small cell lung cancer patients (NSCLC) (n=400), using the statewide research network, documenting usual care (UC) practices, survival and quality of life.

II. Following the 6 month observation period, conduct a 3 year clinical trial in stage IV NSCLC patients (n=2500) randomized to either UC or free advanced genomic and immunotherapy testing (AGIT) (next generation sequencing tumor or blood circulating tumor deoxyribonucleic acid (DNA) and PD-L1 testing immunohistochemistry staining) with decision support (DS) through a genomics board, followed by medical record review and recontacting of patients.

III. Following the aim 1 six month observation period, for subjects in aim 2 (n=375) who smoke or have recently quit smoking, and their household members who smoke (n=94), to conduct a 1 year smoking cessation intervention trial where subjects are randomized to UC or National Cancer Center Network (NCCN)-driven centralized telephone counseling and decision support (CTC/DS).

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.

After completion of study, patients are followed up every month for 9 months and every 2 months for up to 3 years.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2994 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Beating Lung Cancer in Ohio (BLCIO) Protocol
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy

Procedure: Biospecimen Collection
Undergo collection of tumor tissue and blood sample for repository

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Medical Chart Review
Undergo medical record abstraction
Other Name: Chart Review

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Behavioral: Smoking Cessation Intervention
Undergo usual care or NCCN-driven CTC/DS
Other Name: Smoking and Tobacco Use Cessation Interventions

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.
Procedure: Biospecimen Collection
Undergo tumor tissue and blood sample for AGIT/DS

Other: Laboratory Biomarker Analysis
Correlative studies

Other: Medical Chart Review
Undergo medical record abstraction
Other Name: Chart Review

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Behavioral: Smoking Cessation Intervention
Undergo usual care or NCCN-driven CTC/DS
Other Name: Smoking and Tobacco Use Cessation Interventions




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199651


Contacts
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Contact: The Ohio State University Comprehensive Cancer Center 800-293-5066 OSUCCCClinicaltrials@osumc.edu
Contact: Sarah Reisinger 614-366-4542 Sarah.Reisinger@osumc.edu

Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Peter G. Shields, MD    614-688-6563    peter.shields@osumc.edu   
Principal Investigator: Peter G. Shields, MD         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Peter Shields, MD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Peter Shields, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03199651     History of Changes
Other Study ID Numbers: OSU-17070
NCI-2017-00723 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Adenocarcinoma of Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type