NCT05986318 Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease
| NCT ID | NCT05986318 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | David Palma |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2025-01-07 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 98 participants in total. It began in 2025-01-07 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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. 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 * 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
Contact & Investigator
David Palma, MD
STUDY CHAIR
London Health Sciences Centre, Lawson Health Research Institute
Frequently Asked Questions
Who can join the NCT05986318 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05986318 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05986318 currently recruiting?
Yes, NCT05986318 is actively recruiting participants. Contact the research team at david.palma@lhsc.on.ca for enrollment information.
Where is the NCT05986318 trial being conducted?
This trial is being conducted at Vancouver, Canada, London, Canada, Montreal, Canada.
Who is sponsoring the NCT05986318 clinical trial?
NCT05986318 is sponsored by David Palma. The principal investigator is David Palma, MD at London Health Sciences Centre, Lawson Health Research Institute. The trial plans to enroll 98 participants.
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