Clinical trial · Interventional
Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer
Beating Lung Cancer in Ohio (BLCIO) Protocol
NCT03199651CI-TRIAL-00114992BLCIOrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cigarette Smoker | — | UNRESOLVED | — |
| Current Smoker | — | UNRESOLVED | — |
| Lung Adenocarcinoma | Lung Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Squamous Cell Lung Carcinoma | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage IV Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Smoking Cessation Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (UC)
- description
- 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.
- interventionNames
- 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
- type
- EXPERIMENTAL
- label
- Arm II (AGIT/DS)
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- DERIVEDPark KR, Shields PG, Myers JV, Reisinger SA, Andersen BL. Depression and Inflammation Predict Depression Trajectory of Non-Small Cell Lung Cancer Patients. Biopsychosoc Sci Med. 2025 Jul-Aug 01;87(6):397-404. doi: 10.1097/PSY.0000000000001379. Epub 2025 Jun 11. PMID 40511978
- DERIVEDValentine TR, Park KR, Presley CJ, Shields PG, Andersen BL. Lung cancer patients' illness perceptions: Prognostic for psychological and physical health trajectories. Health Psychol. 2024 Dec;43(12):913-923. doi: 10.1037/hea0001416. Epub 2024 Sep 26. PMID 39325429
- DERIVEDBlevins TR, Lo SB, Coker CA, Arrato NA, Reisinger SA, Shields PG, Andersen BL. COVID-19 or Cancer Stress? Anxiety and Depressive Symptoms in Patients with Advanced Lung Cancer. Int J Behav Med. 2024 Apr;31(2):325-330. doi: 10.1007/s12529-023-10206-w. Epub 2023 Aug 18. PMID 37594667
- DERIVEDAndersen BL, Myers J, Blevins T, Park KR, Smith RM, Reisinger S, Carbone DP, Presley CJ, Shields PG, Carson WE. Depression in association with neutrophil-to-lymphocyte, platelet-to-lymphocyte, and advanced lung cancer inflammation index biomarkers predicting lung cancer survival. PLoS One. 2023 Feb 24;18(2):e0282206. doi: 10.1371/journal.pone.0282206. eCollection 2023. PMID 36827396
- DERIVEDValentine 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. PMID 35604701
- DERIVEDArrato 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. PMID 35130505