Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
98 (estimated)
Sponsor
David Palma · Other
Who this trial is looking for
This trial is looking for patients with lung cancer or limited lung lesions who also have interstitial lung disease. Participants will receive either N-acetylcysteine or a placebo, along with a course of corticosteroids or another placebo, while undergoing radiation therapy.
Are You a Good Fit for This Trial?
Must be takingAnti-fibrotic agentsCorticosteroids
Rules you outActive infectionGlaucomaSclerodermaPsychiatric disorder
You may be able to join if
I have lung cancer or 1-2 lung lesions
I have been diagnosed with interstitial lung disease
I am 18 years old or older
I expect to live more than 6 months
I have an ECOG performance status of 0-3
You may not be able to join if
I have had lung radiotherapy before
I am currently using corticosteroids
I am planning to receive other local treatment while in this trial
I am pregnant
I am currently breastfeeding
I have had recent use of N-acetylcysteine
I have any medical condition that my doctor thinks prevents me from participating
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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,…
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
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