Health TrialsbyHealthPanel

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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBo Lu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Curative Radiotherapy

    Radiation

    Radiation dose of 45 Gy or higher

  • Immunotherapy

    Drug

    checkpoint inhibitor per PI discretion

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinical cardiopulmonary toxicities

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

Time frame
25 months

Secondary outcomes

1

subclinical/asymptomatic cardiopulmonary events

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

Time frame
25 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bo Lu

Lead sponsor

University of Missouri-Columbia

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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