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

Last updated: May 7, 2024
Sponsor: Bo Lu
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-small Cell Lung Cancer

Lung Cancer

Lung Disease

Treatment

Curative Radiotherapy

Immunotherapy

Clinical Study ID

NCT06410300
2093626
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient older than 18 years age

  • Diagnosis of locally advanced lung cancer (NSCLC or SCLC) with planned curativeradiotherapy (45Gy and above) and planned consolidation immunotherapy.

  • Patients who are not receiving concurrent chemotherapy and radiotherapy areeligible.

  • Patients on a clinical trial that includes thoracic radiotherapy andimmunotherapy 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

Exclusion Criteria:

  • Prior thoracic radiotherapy to chest.

  • Patients are excluded if they are not candidates for curative thoracic radiotherapyor immunotherapy.

  • Other severe acute or chronic medical or psychiatric condition that may increase therisk associated with study participation, and in the judgment of the investigatorwould make the subject inappropriate for entry into this study.

Study Design

Total Participants: 125
Treatment Group(s): 2
Primary Treatment: Curative Radiotherapy
Phase:
Study Start date:
April 19, 2024
Estimated Completion Date:
April 19, 2030

Study 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.

Connect with a study center

  • University of Missouri - Ellis Fischel Cancer Center

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

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