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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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Alberta Health Services, Cross Cancer Institude
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
London Regional Cancer Program of the Lawson Health Research Institute
Coordinator of this site? Confirm its status
LondonCanadaUnknown status
CHUM Université de Montréal
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
UHN Princess Margaret Cancer Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Sunnybrook Health Sciences Centre
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
Edinburgh Cancer Centre, Western General Hospital
Coordinator of this site? Confirm its status
EdinburghUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.