Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

Bo Lu

Status: Enrolling

Conditions: Lung Cancer

Treatments: Drug: Immunotherapy; Radiation: Curative Radiotherapy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06410300

2093626

Details and patient eligibility

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.

Full 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.

Enrollment: 125 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.