Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell… (NCT06634056) | Clinical Trial Compass
RecruitingPhase 2
Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients Undergoing Chemoradiation
Canada150 participantsStarted 2026-06-15
Plain-language summary
Currently, the standard of care treatment for newly diagnosed, inoperable stage III non-small cell lung cancer is radiotherapy (RT) with concurrent chemotherapy, followed by immune checkpoint inhibitors (ICI). RT is a highly effect local treatment. However, high doses of radiation used in curative settings can cause adverse side effects. The most common RT side effect in lung cancer is Radiation Induced Lung Injury (RILI), which can manifest as pneumonitis and/or pulmonary fibrosis. Lung injury can negatively impact patients' well-being and quality of life, and may lead to increased mortality. Risk of lung injury is particularly increased when patients are treated with a combination of treatments (i.e., RT, chemotherapy, and ICI). The drug Pentoxifylline (in combination with α-Tocopherol (Vitamin E)) has been shown to prevent/alter the progression of lung injury and there is a growing body of evidence to support the safety and efficacy of phosphodiesterase inhibitors in cancer treatment. The proposed study aims to determine if the addition of Pentoxifylline, given in combination with α-Tocopherol (Vitamin E), to standard of care treatment will reduce side effects related to lung injury and improve quality of life in this study population.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female and/or male aged ≥ 18 years.
* Histologically confirmed diagnosis of stage III NSCLC, planned for treatment with concurrent chemoradiation and consolidation immune checkpoint inhibitor as per standard of care with no medical contraindications to therapy.
* Patients with ECOG performance status 0-2 within 4 weeks of randomization.
* Adequate liver function (no evidence of Child-Pugh class C disease or cirrhosis) as per blood work done within 30 days of registration.
* Adequate kidney function (Creatinine clearance \> 50 mL/min) as per blood work done within 30 days of registration.
Exclusion Criteria:
* Participation in another clinical study with an investigational product during the last 6 months prior to registration.
* Patients who will have surgery as part of curative treatment.
* Previous radiotherapy to intended treatment volumes in the thorax.
* Active pregnancy.
* Life expectancy of less than 12 months.
* Hypersensitivity to Pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or tocopherol (vitamin E).
* Participant has a history of acute (within 3 months) myocardial infarction, coronary artery disease, or cardiac arrhythmias.
* Ongoing hemorrhage or major bleeding risk. Patients on antiplatelets agents and anticoagulants (Aspirin, Clopidogrel, Ticlopidine, Cilostazol, Dipyridamole, Heparin, Dalteparin, Enoxaparin and Warfarin) can be enrolled, but major bleeding events will be captured. Patients on Warfarin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing pentoxifylline and alpha-tocopherol — a blood-flow medication and vitamin E — to try to prevent radiation-related lung damage during chemoradiation for Stage III non-small cell lung cancer. Is this combination something worth discussing as an add-on to my planned treatment, and do you think I'd be a good candidate?
2Since this is a Phase 2 trial, we're still in the earlier stages of figuring out how safe and effective this approach is — what do you know so far about the safety profile of adding pentoxifylline and alpha-tocopherol to chemoradiation, and are there any risks I should weigh carefully given my specific health situation?
3Radiation-induced lung injury is one of the serious complications of chemoradiation for lung cancer — how significant is that risk for me personally, and does this trial seem like a meaningful way to address it compared to what's already done in standard care?
4How would joining this trial affect my overall chemoradiation treatment plan — would I be taking these medications throughout radiation, and how much extra monitoring or follow-up would be involved on top of my regular appointments?
5If I don't join this trial, is there anything in standard practice already used to reduce radiation-related lung injury, and would that be a better first path for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.