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

July 28, 2026 updated by: Bo Lu

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

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.

Study Overview

Status

Recruiting

Conditions

Lung Cancer

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Brooke McDaniel
Phone Number: (573) 882-7440
Email: mcdanielbl@health.missouri.edu

Study Locations

United States
- Missouri
  - Columbia, Missouri, United States, 65212
    - Recruiting
    - University of Missouri - Ellis Fischel Cancer Center
    - Principal Investigator:
      
      Bo Lu, MD
    - Sub-Investigator:
      
      Gregory Biedermann, MD
    - Sub-Investigator:
      
      Ruobing Xue, MD
- New Jersey
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - Rutgers Cancer Institute of New Jersey
    - Principal Investigator:
      
      Salma Jabbour, MD
- New York
  - Rochester, New York, United States, 14642
    - Recruiting
    - University of Rochester Medical Center
    - Principal Investigator:
      
      Yuhchyau Chen, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cardiopulmonary toxicities Time Frame: 25 months	To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0	25 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
subclinical/asymptomatic cardiopulmonary events Time Frame: 25 months	Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing	25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo Lu

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Bo Lu, MD, Chair, Department of Radiation Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2024

Primary Completion (Estimated)

April 19, 2028

Study Completion (Estimated)

April 19, 2030

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria