Pneumonitis Prevention with Pentoxifylline and Vitamin E in Stage III NSCLC with Chemoradiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-centre, Phase II, double-blind, placebo-controlled randomized trial. Eligible patients have newly diagnosed, inoperable stage III NSCLC and will receive radical-intent concurrent chemoradiation followed by consolidation immune checkpoint inhibitor therapy. Participants are randomized 1:1 to receive either pentoxifylline with α-tocopherol for six months or matched placebos. The study aims to see if the combination can reduce radiation-induced lung injury without adding safety concerns. Primary and secondary endpoints will assess lung injury incidence and safety signals in the context of standard-of-care treatment.

Why it matters

Who can join: the full rules

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 will need frequent monitoring of their coagulation time to adjust Warfarin dosage.

Where it's running

• University Health Network - Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Philip Wong MD
• Email: philip.wong4@uhn.ca
• Phone: 416-946-4501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.