NCT03485378Active, not recruiting
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease
Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial
Source: ClinicalTrials.gov · Last updated 18 Sept 2025
Brief summary (registry, in English)
This is a prospective phase II study of Stereotactic Ablative Radiotherapy (SABR) in patients with Non-Small Cell Lung Cancer (NSCLC) and co-existent Interstitial Lung Disease (ILD), to determine oncologic and toxicity outcomes. Patients will be divided into 3 separate cohorts based on the ILD-GAP index.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 7 Mar 2018
- Start date
- 20 Sept 2018
- Primary completion date
- 11 Jan 2022
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Lung cancer
- NCT number
- NCT03485378
What you commit to
- Study type: Interventional
- Planned participants: 39
- From 20 Sept 2018 to the primary completion date, 11 Jan 2022
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior thoracic radiotherapy
- Plans for the patient to receive systemic therapy (including standard chemotherapy or biologic targeted agents), while on this study, except at disease progression. Patients are allowed to receive anti-fibrotic agents used in the treatment of IPF or non-IPF fibrotic ILD (e.g. nintedanib, pirfenidone), or steroids, 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 treatment.
- Concurrent administration of any drugs with known radiosensitive effects (e.g. Methotrexate).
Other illness
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (e.g., carcinomas in situ of the breast, oral cavity, or cervix are permissible); previous lung cancer, if the patient is disease-free for a minimum of 2 years is permitted.
- Plans for the patient to receive other local therapy while on this study, except at disease progression;
Other
- Active pregnancy
Who the study is looking for
- Stage T1-2, N0, M0 (AJCC Staging, 8th Edition - i.e. tumor size ≤ 5 cm) prior to registration.
- Not a candidate for surgical resection, determined by any of the following:
- Consultation with a thoracic surgeon
- Discussion at Multidisciplinary Team (MDT) rounds with a surgeon present
- Patient refusal of surgery
- Pathologically (histologically or cytologically) proven diagnosis of non-small cell lung cancer (NSCLC) 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 a primary NSCLC.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3;
- Age ≥ 18;
- Life expectancy \> 6 months
- Fibrotic interstitial lung disease of any subtype, as diagnosed by a respirologist/pulmonologist.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Alberta Health Services, Cross Cancer Institude Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Regional Cancer Program of the Lawson Health Research Institute Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHUM Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| UHN Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Edinburgh Cancer Centre, Western General Hospital Coordinator of this site? Confirm its status | Edinburgh | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.