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

NCT ID: NCT06410300

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-19

Study Completion Date

2030-04-19

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Curative Radiotherapy

Radiation dose of 45 Gy or higher

Intervention Type RADIATION

Immunotherapy

checkpoint inhibitor per PI discretion

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Bo Lu

OTHER

Sponsor Role lead

Responsible Party

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Bo Lu

Chair & Professor, Department of Radiation Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bo Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Chair, Department of Radiation Oncology

Locations

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University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, United States

Site Status RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status NOT_YET_RECRUITING

University of Rochester Medical Center

Rochester, New York, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Hilary Elom, MD

Role: CONTACT

318-816-3582

Other Identifiers

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2093626

Identifier Type: -

Identifier Source: org_study_id

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