Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06410300

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Missouri - Ellis Fischel Cancer Center, Columbia, Missouri, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Curative radiotherapy

Radiation

Radiation dose of 45 Gy or higher

Immunotherapy

Drug

checkpoint inhibitor per PI discretion

Primary outcomes

  1. Clinical cardiopulmonary toxicities

    Time frame: 25 months

    To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0

Secondary outcomes

  1. subclinical/asymptomatic cardiopulmonary events

    Time frame: 25 months

    Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke McDaniel

CONTACT

[email protected]

(573) 882-7440

Sponsors and collaborators

Lead sponsor

Bo Lu

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
May 13, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.