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

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: Radiation: Curative Radiotherapy; Drug: Immunotherapy

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

• Study Contact: Name: Hilary Elom, MD; Phone Number: 318-816-3582; Email: hebcq@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
      • Not yet recruiting
      • Rutgers Cancer Institute of New Jersey
      • Principal Investigator: Salma Jabbour, MD
  • New York
    • Rochester, New York, United States, 14642
      • Not yet recruiting
      • University of Rochester Medical Center
      • Principal Investigator: Yuhchyau Chen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical cardiopulmonary toxicities	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	Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing	25 months

Collaborators and Investigators

• Sponsor: Bo Lu
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Bo Lu, MD, Chair, Department of Radiation Oncology

Study record dates

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: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Immunomodulating Agents
• Other Study ID Numbers: 2093626

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No