Recruiting
Phase 2

Pulmonary Irradiation

Sponsor:

David Palma

Code:

NCT05986318

Conditions

Lung Cancer

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

N-Acetyl cysteine

Dexamethasone Oral

N-Acetyl cysteine Placebo

Dexamethasone Placebo

Radiation Therapy

Study Details

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.

Conditions

Lung Cancer

Interstitial Lung Disease

Study ID

NCT05986318

Start date

Jan 7, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2032

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: NAC + Corticosteroids

Participants will take 600 mg of active NAC orally, three times daily, for 60 days.

Participants will also take 4 mg of active dexamethasone, orally, once daily for 10 days, then 2 mg, orally, once daily for 5 days, then 1 mg, orally, once daily for 5 days.

All participants will be treated with radical pulmonary radiation therapy.

active comparator: Corticosteroids + NAC Placebo

Participants will take 4 mg of active dexamethasone, orally, once daily for 10 days, then 2 mg, orally, once daily for 5 days, then 1 mg, orally, once daily for 5 days.

Participants will also take matching NAC placebo orally, three times daily, for 60 days.

All participants will be treated with radical pulmonary radiation therapy.

active comparator: NAC + Dexamethasone Placebo

Participants will take 600 mg of active NAC orally, three times daily, for 60 days.

Participants will also take matching dexamethasone placebo (4 mg for 10 days, then 2 mg for 5 days, then 1 mg for 5 days), orally, once daily.

All participants will be treated with radical pulmonary radiation therapy.

placebo comparator: NAC Placebo + Dexamethasone Placebo

Participants will take matching NAC placebo orally, three times daily, for 60 days.

Participants will also take matching dexamethasone placebo (4 mg for 10 days, then 2 mg for 5 days, then 1 mg for 5 days), orally, once daily.

All participants will be treated with radical pulmonary radiation therapy.

Interventions

N-Acetyl cysteine

NAC capsules

Dexamethasone Oral

Dexamethasone tablets

N-Acetyl cysteine Placebo

Matching placebo for NAC capsules

Dexamethasone Placebo

Matching placebo for dexamethasone tablets

Radiation Therapy

All participants will receive radical pulmonary radiation therapy. Conventional techniques or stereotactic ablative radiotherapy will be used.

Primary outcome measure

  • Rate of Grade 2-5 Dyspnea within 6 Months Post Radiation Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 [ Time Frame: Up to 6 months post radiation therapy ]

Central Contacts and Locations

Central contacts

David Palma, MD

519-685-8650david.palma@lhsc.on.ca

Houda Bahig, MD

514-890-8254houda.bahig.chum@ssss.gouv.qc.ca

Locations

BC-Cancer Agency - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

Contacts

Sijia (Jackie) Cao, CCRP

604-877-6000sijia.cao@bccancer.bc.ca

Fermin Hoq

604-877-6000fermin.hoq1@bccancer.bc.ca

Principal Investigator:

Srinivas Raman, MD,FRCPC

Saint John Regional Hospital-Horizon Health Network

Recruiting

Saint John, New Brunswick, Canada, E2L4L2

Contacts

Robert Thompson, MD

506-648-6890robert.thompson2@horizonnb.ca

Carrie Folkins, RN

506-648-6890Carrie.Folkins@HorizonNB.ca

Principal Investigator:

Robert Thompson, MD

Verspeeten Family Cancer Centre, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

David Palma, MD

519-685-8650David.Palma@lhsc.on.ca

Centre Hospitalier de l'Universite de Montreal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Mom Phat

514-890-8000mom.phat.chum@ssss.gouv.qc.ca

Siew Siew Pan

514-890-8000siew.siew.pan.chum@ssss.gouv.qc.ca

Principal Investigator:

Houda Bahig, MD

More Information

Sponsor

David Palma

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Pulmonary Irradiation
  • Radiation Therapy
  • N-Acetyl Cysteine
  • Dexamethasone
  • Radiation Pneumonitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Palma on 2026-08-26.