Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Recruiting · NCT06410300 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Curative RadiotherapyImmunotherapy
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 it is running
3 locations listed across 3 US states.
- University of Missouri - Ellis Fischel Cancer Center - Columbia, Missouri, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- University of Rochester Medical Center - Rochester, New York, United States