Lung CancerNCT06410300
Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
An observational study of Lung Cancer, run by Bo Lu at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Curative Radiotherapy and Immunotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Apr 2024to 19 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
Bo Lu, MD
Gregory Biedermann, MD
- Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Salma Jabbour, MD
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Yuhchyau Chen, MD, PhD
About this study
Official title: A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Curative Radiotherapy, Immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curative RadiotherapyRadiation
Radiation dose of 45 Gy or higher
ImmunotherapyDrug
checkpoint inhibitor per PI discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cardiopulmonary toxicities
To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0
Measured: 25 months
Secondary outcomes (1)
subclinical/asymptomatic cardiopulmonary events
Asymptomatic cardiopulmonary events determined per abnormal lab values such as troponin and physiological testing
Measured: 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start19 Apr 2024
- Primary completion19 Apr 2028 (estimated)
- Study completion19 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Lu
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Bo Lu, University of Missouri-Columbia
- Investigators
- Bo Lu, MD, Principal investigator, Chair, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410300
- Sponsor's protocol ID
- 2093626
- Status last verified
- Jul 2026
- First submitted
- 7 May 2024
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
- ClinicalTrials.gov ID
- NCT06410300
- Acronym / sponsor ID
- 2093626
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Bo LuUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 19 Apr 2028 (estimated)
- Study completion
- 19 Apr 2030 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curative RadiotherapyRadiation dose of 45 Gy or higher | Radiation | – |
| Immunotherapycheckpoint inhibitor per PI discretion | Drug | – |
Primary outcome
Clinical cardiopulmonary toxicities
Time frame: 25 months
To determine clinical cardiopulmonary toxicities from standard RT and immunotherapy per CTCAEv5.0
1 secondary outcome
subclinical/asymptomatic cardiopulmonary events
Time frame: 25 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Lu, MD principal investigator
Chair, Department of Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Bo Lu at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooke McDaniel ((573) 882-7440, mcdanielbl@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cardiopulmonary toxicities (time frame: 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.