A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Summary
The overall purpose of this study is to evaluate cardiopulmonary toxicity in patients with lung cancer (NSCLC or SCLC) undergoing combined thoracic radiotherapy ± chemotherapy and immunotherapy through timed monitoring and blood sample collection and to identify correlative biomarkers for predicting cardiopulmonary adverse events.
Detailed description
This aims to collect observational data that describe clinical (primary endpoint) and subclinical (secondary endpoint) cardiopulmonary toxicities from combined thoracic radiotherapy and immunotherapy up to 25 months after thoracic radiotherapy and 12 months after consolidation immunotherapy among patients with locally advanced lung cancer.
Arms & interventions
- RadiationCurative Radiotherapy
Radiation dose of 45 Gy or higher
- DrugImmunotherapy
checkpoint inhibitor per PI discretion
Outcome measures
Primary
Clinical cardiopulmonary toxicities
To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0
Time frame: 25 months
Secondary
subclinical/asymptomatic cardiopulmonary events
Time frame: 25 months
Eligibility criteria
Study locations (3)
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
University of Rochester Medical Center
Rochester, New York, 14642