Who is eligible for clinical trial NCT05986318?

Participants must meet protocol criteria for Lung Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT05986318 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-24

Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease (NCT05986318)

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: David Palma

🩺 Plain-English Summary (8th-Grade Level)

In this double-blind phase II randomized controlled trial, patients with lung cancer or ≤2 oligometastatic pulmonary lesions and a concomitant diagnosis of ILD who are planned for radical Radiation Therapy (RT) will be randomized using a 2 x 2 factorial design to oral N-acetylcysteine (NAC) versus placebo, and also to short course corticosteroids versus placebo.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (24 items).

Location: BC-Cancer Agency - Vancouver — Vancouver, British Columbia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Lung cancer or 1-2 oligometastatic pulmonary lesions planned for radical intent radiotherapy \[minimal Biologically Effective Does (BED) of 48 Gy10 (Gray) or biological equivalent\].
Pathologically (histologically or cytologically) proven diagnosis of cancer is not required, but strongly recommended.
If the risk of biopsy is unacceptable, pathologic confirmation is not required providing there is growth over time on Computed Tomography (CT) imaging and/or Fluorodeoxyglucose (FDG) avidity that is strongly suggestive of malignancy.
Fibrotic Interstitial Lung Disease (ILD) of any subtype, as diagnosed by a respirologist and confirmed by central review
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
Age ≥ 18
Life expectancy \> 6 months
Patients are allowed to receive anti-fibrotic agents used in the treatment of Idiopathic Pulmonary Fibrosis (IPF) or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone) and/or corticosteroids, if those are part of their current ILD treatment regimen. Other immunosuppressive drugs such as mycophenolate, azathioprine, cyclophosphamide, and rituximab must be stopped for 2 weeks prior and 2 weeks after Radiation Therapy (RT).
Concurrent standard chemotherapy is allowed where indicated. All other systemic therapies, including biologic targeted agents or immunotherapy, or any drugs with known radiosensitive effects, must be stopped for 2 weeks prior and 2 weeks after treatment.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Prior lung radiotherapy
Current use of oral or intravenous corticosteroids
Plans for the patient to receive other local therapy to the target lesion(s) while on this study, except at disease progression
Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy
Pregnancy
If not pregnant, use of effective contraception methods for women of childbearing age is required which can include:
hormonal methods (e.g. oral, injected, implanted),
placement of an intrauterine device,
barrier methods (i.e. condoms),
sterilization of the partner (e.g. previous vasectomy)
abstinence

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (4 Sites)

BC-Cancer Agency - Vancouver — Vancouver, British Columbia
Saint John Regional Hospital-Horizon Health Network — Saint John, New Brunswick
Verspeeten Family Cancer Centre, London Health Sciences Centre — London, Ontario
Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗