Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
A Multi-Center Pilot Biomarker Study With Cardiopulmonary Monitoring in Lung Cancer Patients Receiving Combined Thoracic Radiotherapy and Immunotherapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 25 months
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study checks for heart and lung harm in people with lung cancer who receive chest radiation and immunotherapy, with or without chemotherapy. Immunotherapy helps the immune system fight cancer. The study uses checks at set times and blood samples to look for signs that may predict heart and lung problems.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Older than 18 years.
- Have non-small cell or small cell lung cancer that has spread nearby.
- Plan to receive chest radiation aimed at curing the cancer, at a dose of at least 45 Gy, followed by immunotherapy.
- Can join even if you are not receiving chemotherapy and radiation at the same time.
- Can join even if you are in another trial that includes chest radiation and immunotherapy.
- Can care for yourself and are up and about for at least half of your waking hours (ECOG score 0–2).
- Expected to live at least 6 months.
- Can give written consent before joining the study.
Who can't join
- Have had radiation to the chest before.
- Cannot receive chest radiation aimed at curing the cancer or immunotherapy.
- Have another serious physical or mental health condition that the study doctor thinks would make joining unsafe or unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (3)
MO
- University of Missouri - Ellis Fischel Cancer Center · Columbia, MO 65212Bo Lu, MD · Principal investigatorGregory Biedermann, MD · Sub-investigatorRuobing Xue, MD · Sub-investigatorMore trials in Columbia
NJ
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08901Salma Jabbour, MD · Principal investigatorMore trials in New Brunswick
NY
- University of Rochester Medical Center · Rochester, NY 14642Yuhchyau Chen, MD, PhD · Principal investigatorMore trials in Rochester