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RecruitingObservational

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

NCT ID: NCT06410300Sponsor: Bo LuLast updated: 2025-06-19

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.

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.

Arms & interventions

  • RadiationCurative Radiotherapy

    Radiation dose of 45 Gy or higher

  • DrugImmunotherapy

    checkpoint inhibitor per PI discretion

Outcome measures

Primary

  • Clinical cardiopulmonary toxicities

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

    Time frame: 25 months

Secondary

  • subclinical/asymptomatic cardiopulmonary events

    Time frame: 25 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (3)

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, 65212

Recruiting
Bo Lu, MD · Principal Investigator
Gregory Biedermann, MD · Sub Investigator
Ruobing Xue, MD · Sub Investigator

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Not Yet Recruiting
Salma Jabbour, MD · Principal Investigator

University of Rochester Medical Center

Rochester, New York, 14642

Not Yet Recruiting
Yuhchyau Chen, MD, PhD · Principal Investigator