Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Lung Cancer, Interstitial Lung Disease

In brief

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.

Key facts

Study ID: NCT05986318
Run by: David Palma
People needed: 98
Starts: 2025-01-07
Expected to finish: 2032-12-31
Last updated by the study team: 2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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
Women who become pregnant should stop taking NAC and/or dexamethasone and inform their study doctor.
Male participants should use adequate forms of birth control with their partners.
Currently breastfeeding
Current or recent use of NAC
Contraindications to dexamethasone or N-Acetyl Cysteine (NAC). These include:
Previous intolerance or allergy to dexamethasone or NAC
Scleroderma
Active infection
Glaucoma
Psychiatric disorder that could be exacerbated by dexamethasone
Cystinuria
Any other condition that the treating physician believes to be a contraindication to dexamethasone or NAC

Where it is running

BC-Cancer Agency - Vancouver — Vancouver, British Columbia, Canada (enrolling)
Verspeeten Family Cancer Centre, London Health Sciences Centre — London, Ontario, Canada (enrolling)
Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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