What this study is
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.
What's being tested
- Best Practice
Intervention · OTHER
Receive usual care
- Biospecimen Collection
Intervention · PROCEDURE
Undergo collection of tumor tissue and blood sample for repository
- Biospecimen Collection
Intervention · PROCEDURE
Undergo tumor tissue and blood sample for AGIT/DS
- Laboratory Biomarker Analysis
Intervention · OTHER
Correlative studies
- Medical Chart Review
Intervention · OTHER
Undergo medical record abstraction
- Quality-of-Life Assessment
Intervention · OTHER
- Questionnaire Administration
Intervention · OTHER
- Smoking Cessation Intervention
Intervention · BEHAVIORAL
Undergo usual care or NCCN-driven CTC/DS
Both Quality-of-Life Assessment and Questionnaire Administration
Ancillary studies
Study details
- Official title
- Beating Lung Cancer in Ohio (BLCIO) Protocol
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Conditions
- Cigarette Smoker · Current Smoker · Lung Adenocarcinoma · Squamous Cell Lung Carcinoma · Stage IV Non-Small Cell Lung Cancer
- Enrolling
- 3,584 people
- Starts
- 2017-07-17
- Est. completion
- 2028-12-31
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Being treated with definitive chemoradiotherapy or surgery
- Receiving treatment for advanced lung cancer for over one month before enrollment; OR
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOhio State University Comprehensive Cancer Center
Columbus, Ohio, United States
- Peter G. Shields, MD · Contact614-688-6563peter.shields@osumc.edu
- Peter G. Shields, MD · Principal investigator
Recruiting
Study team
Sponsor
Ohio State University Comprehensive Cancer Center
Study ID OSU-17070
Principal investigator
Peter Shields, MD
Ohio State University Comprehensive Cancer Center
CONTACT
The Ohio State University Comprehensive Cancer Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.