Official Title
Beating Lung Cancer in Ohio (BLCIO) Protocol
Brief Title
Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer
Protocol ID
NCT03199651
Lead Sponsor
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.
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.
2. 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).
3. 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).
4. 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.
Study Period
-
Enrollment Count
3,584 participants
Eligibility 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
Filters
Cigarette Smoker
Current Smoker
Lung Adenocarcinoma
Squamous Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
NA
RECRUITING
ADULT
OLDER_ADULT