Clinical trial NCT03199651: Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients with Stage IV Non-Small Cell Lung Cancer
Official title: Beating Lung Cancer in Ohio (BLCIO) Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cigarette Smoker
Current Smoker
Lung Adenocarcinoma
Squamous Cell Lung Carcinoma
Stage IV Non-Small Cell Lung Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-06-27
Enrollment: 3584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Cost-Effectiveness Analysis
timeFrame: Up to 24 months
measure: Overall survival (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients receiving first line targeted therapy (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients receiving genomic testing at diagnosis and type of genomic testing (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients receiving genomic testing later in treatment (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients receiving off label therapy (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients referred to clinical trials (Aim I observational phase)
timeFrame: Up to 3 years
measure: Percent of patients who enroll in therapeutic clinical trials (Aim I observational phase)
timeFrame: Up to 3 years
measure: Progression free survival (Aim I observational phase)
timeFrame: Up to 3 years
measure: Quality of life assessed using European Organization for Research and Treatment-quality of life questionnaire
timeFrame: Up to 24 months
measure: Smoking cessation (Aim III centralized telephone counseling/decision support)
timeFrame: Up to 6 months
measure: Survival (Aim 2 advanced genomic and immunotherapy testing/decision support)
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Peter Shields, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Valentine TR, Presley CJ, Carbone DP, Shields PG, Andersen BL. Illness perception profiles and psychological and physical symptoms in newly diagnosed advanced non-small cell lung cancer. Health Psychol. 2022 Jun;41(6):379-388. doi: 10.1037/hea0001192.
citation: Arrato NA, Lo SB, Coker CA, Covarrubias JJ, Blevins TR, Reisinger SA, Presley CJ, Shields PG, Andersen BL. Cancer Treatment During COVID-19: Resilience of Individuals With Advanced Non-Small Cell Lung Cancer Versus Community Controls. J Natl Compr Canc Netw. 2022 Feb;20(2):118-125. doi: 10.6004/jnccn.2021.7076.
citation: Andersen BL, McElroy JP, Carbone DP, Presley CJ, Smith RM, Shields PG, Brock GN. Psychological Symptom Trajectories and Non-Small Cell Lung Cancer Survival: A Joint Model Analysis. Psychosom Med. 2022 Feb-Mar 01;84(2):215-223. doi: 10.1097/PSY.0000000000001027.
citation: Andersen BL, Valentine TR, Lo SB, Carbone DP, Presley CJ, Shields PG. Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms. Lung Cancer. 2020 Jul;145:195-204. doi: 10.1016/j.lungcan.2019.11.015. Epub 2019 Nov 21.