Lung Cancer
Conditions
Brief 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.
Interventions
RADIATIONCurative Radiotherapy
Radiation dose of 45 Gy or higher
DRUGImmunotherapy
checkpoint inhibitor per PI discretion
Sponsors
National Cancer Institute (NCI)
Bo Lu
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical cardiopulmonary toxicities | 25 months | To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| subclinical/asymptomatic cardiopulmonary events | 25 months | Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing |
Countries
United States
Contacts
Primary ContactHilary Elom, MD
Outcome results
None listed