Clinical trial NCT06410300: Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Official title: A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-05-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 125 patients (MU: 25 patients, UR: 50 patients, Rutgers: 50 patients) who are 18 year of age or older, diagnosed with locally advanced lung cancer (defined as above) will be accrued in the study.

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.

Eligibility 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.

Primary outcomes:
measure: Clinical cardiopulmonary toxicities
timeFrame: 25 months
Secondary outcomes:
measure: subclinical/asymptomatic cardiopulmonary events
timeFrame: 25 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri - Ellis Fischel Cancer Center
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: Chair, Department of Radiation Oncology
name: Bo Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: