Monitoring heart and lung health in lung cancer patients receiving radiation and immunotherapy
A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
This study is testing how radiation and immunotherapy for lung cancer affect heart and lung health over time in patients with advanced lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Columbia, Missouri and 2 other locations) |
| Trial ID | NCT06410300 on ClinicalTrials.gov |
What this trial studies
This study evaluates cardiopulmonary toxicity in lung cancer patients undergoing combined thoracic radiotherapy and immunotherapy. It involves timed monitoring and blood sample collection to assess both clinical and subclinical cardiopulmonary toxicities. The research aims to identify biomarkers that can predict adverse cardiopulmonary events over a period of up to 25 months after radiotherapy and 12 months after immunotherapy. The study focuses on patients with locally advanced lung cancer, specifically non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with locally advanced lung cancer who are scheduled for curative thoracic radiotherapy and immunotherapy.
Not a fit: Patients who are not candidates for curative thoracic radiotherapy or immunotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiopulmonary side effects in lung cancer patients undergoing treatment.
How similar studies have performed: Other studies have explored cardiopulmonary toxicity in cancer treatments, but this specific approach of combined monitoring and biomarker identification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient older than 18 years age * Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curative radiotherapy (45Gy and above) and planned consolidation immunotherapy. * Patients who are not receiving concurrent chemotherapy and radiotherapy are eligible. * Patients on a clinical trial that includes thoracic radiotherapy and immunotherapy are eligible and may be co-enrolled to this study. * ECOG performance status of 0-2 * Life expectancy of 6 months or longer * Patient able to provide a written informed consent prior to study entry Exclusion Criteria: * Prior thoracic radiotherapy to chest. * Patients are excluded if they are not candidates for curative thoracic radiotherapy or immunotherapy. * Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation, and in the judgment of the investigator would make the subject inappropriate for entry into this study.
Where this trial is running
Columbia, Missouri and 2 other locations
- University of Missouri - Ellis Fischel Cancer Center — Columbia, Missouri, United States (Recruiting)
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (Not_yet_recruiting)
- University of Rochester Medical Center — Rochester, New York, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Bo Lu, MD — Chair, Department of Radiation Oncology
- Study coordinator: Hilary Elom, MD
- Email: hebcq@health.missouri.edu
- Phone: 318-816-3582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.