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

Lung Cancer Clinical Trial

Official title:

A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410300
• Other study ID #: 2093626
• Status: Recruiting
• Start date: April 19, 2024
• Est. completion date: April 19, 2030

Study information

• Verified date: May 2024
• Source: University of Missouri-Columbia
• Contact: Hilary Elom, MD
• Phone: 318-816-3582
• Email: hebcq[@]health.missouri.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: April 19, 2030
• Est. primary completion date: April 19, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Curative Radiotherapy
Radiation dose of 45 Gy or higher

Drug:
• Immunotherapy
checkpoint inhibitor per PI discretion

Locations

Country	Name	City	State
United 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

Sponsors (2)

Lead Sponsor	Collaborator
Bo Lu	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cardiopulmonary toxicities	To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0	25 months
Secondary	subclinical/asymptomatic cardiopulmonary events	Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing	25 months