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

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06410300
• Lead Sponsor: Bo Lu

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.

Study Timeline

• Study Start: 2024-04-19
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2028-04-19
• Study Completion: 2030-04-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical cardiopulmonary toxicities	25 months	To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0

Secondary Outcome Measures

Name	Time	Method
subclinical/asymptomatic cardiopulmonary events	25 months	Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing

Trial Locations

Locations (3)

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