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Can a drug combo shield lungs from radiation damage?

NCT ID NCT06634056

Disease control Sponsor: University Health Network, Toronto Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 3 times

Summary

This study tests whether taking pentoxifylline and vitamin E during chemoradiation can prevent lung injury (pneumonitis) in stage III non-small cell lung cancer patients. 150 participants will receive either the drug combo or a placebo for 6 months. The goal is to see if this reduces side effects and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pentoxifylline and vitamin E (α-tocopherol)
What this could lead to
If it works, this could reduce the risk of radiation-induced lung injury and improve quality of life for lung cancer patients.
What could go wrong
This is a Phase 2 trial with 150 participants, so results are still early. The drugs may not prevent lung injury, and side effects from the combination are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Nov 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma radiation pneumonitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer Radiation induced lung injury (RILI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Health Network - Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C1, Canada

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