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

NCT06410300 | Recruiting

• 1 other identifier: 2093626
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Clinical cardiopulmonary toxicities

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

  25 months

Secondary Outcomes (1)

• subclinical/asymptomatic cardiopulmonary events

  25 months

Interventions

Curative Radiotherapy RADIATION

Radiation dose of 45 Gy or higher

Immunotherapy DRUG

checkpoint inhibitor per PI discretion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bo Lu: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

RECRUITING

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

NOT YET RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma \& PBMC samples will be collected as per protocol required. Samples will be analyzed per protocol.

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Bo Lu, MD

  Chair, Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilary Elom, MD

CONTACT

318-816-3582; hebcq@health.missouri.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair & Professor, Department of Radiation Oncology

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: April 19, 2024
• Primary Completion (Estimated): April 19, 2028
• Study Completion (Estimated): April 19, 2030
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (3)