AzTrials
AzTrials

Non Small Cell Lung CancerASPIRE-ILDNCT03485378

Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease

A study testing Stereotactic Ablative Radiotherapy in people with Non Small Cell Lung Cancer and Interstitial Lung Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Stereotactic Ablative Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
6 sitesin 2 countries
Study dates
20 Sep 2018to 20 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.
  • Prior thoracic radiotherapy
  • Plans for the patient to receive other local therapy while on this study, except at disease progression;
  • 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.
  • Active pregnancy
  • Concurrent administration of any drugs with known radiosensitive effects (e.g. Methotrexate).

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Canada5 sites

  • Alberta Health Services, Cross Cancer Institude

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program of the Lawson Health Research Institute

    London, Ontario, N6A 4L6

  • CHUM Université de Montréal

    Montreal, Quebec, H2X 0A9

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

  • UHN Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

United Kingdom1 site

  • Edinburgh Cancer Centre, Western General Hospital

    Edinburgh, EH4 2XU

Other trials in United Kingdom

About this study

Official title: Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease (ASPIRE-ILD): A Phase II Trial

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.

Read the detailed description

For patients with ILD and concurrent early-stage lung cancer who are not candidates for surgery, data showing high rates of toxicity have led to a difficult clinical dilemma, since there are few alternate treatment options. The option of delivering no treatment whatsoever, which avoids any risk of treatment-related toxicity, is associated with a high risk of death due to the lung cancer itself.

Stereotactic ablative radiotherapy (SABR) is a newer radiotherapy approach which uses modern radiotherapy planning and targeting technologies to precisely deliver larger, ablative doses of radiotherapy. SABR has been associated with high rates of local control. A major advantage of SABR is that in general, the toxicity profile is very favorable, even in patients with substantial co-morbid conditions.

It is possible that currently-used doses and fractionations of SABR, when given with strict planning criteria to minimize the risk of lung toxicity, have only a modest risk of treatment-related toxicity and represent the best possible approach.

This study will examine SABR versus a historical control of untreated stage I non-small cell lung cancer with Overall survival (OS) as the endpoint. OS was selected as it objectively reflects the potential benefits of treatment (i.e. extended survival), the harms of treatment (grade 5 toxicity), and the natural history of the ILD disease process itself.

Being tested
Stereotactic Ablative Radiotherapy
Keywords
Stereotactic, Ablative, Radiation
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Ablative RadiotherapyRadiation

    Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease

Study groups in NCT03485378
Study groupRoleWhat they receive
Treatment Arm: Stereotactic Ablative RadiotherapyExperimentalStereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
Receives: Radiation: Stereotactic Ablative Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Time from enrollment to death from any cause

    Measured: 4 years

Secondary outcomes (12)

  1. Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: 8 years

  2. Progression-Free Survival

    Measured: 8 years

  3. Local Control as determined via radiographic evidence

    Measured: 8 years

  4. Cough Severity as reported by the participant via 10 cm analogue Cough Severity Scale

    Cough severity will be reported by participants via a scale, where a score of 100 is no cough and a score of 0 is the worst cough ever.

    Measured: 8 years

  5. Rates of Acute-Exacerbation of Idiopathic Pulmonary Fibrosis (IPF)

    Measured: 8 years

  6. Rates of Acute-Exacerbation of ILD

    Measured: 8 years

  7. Quality of Life measured by the Functional Assessment of Cancer Therapy - Lung questionnaire

    The Functional Assessment of Cancer Therapy - Lung (FACT-L ) is a standardized questionnaire used to measure quality of life. The questionnaire consists of 5 scales measuring 37 items in total. Categories of the 5 scales are: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns related to symptoms, cognitive function, and regret of smoking. The score for each item in the scale ranges from 0 to 4, where 0 is not at all and 4 is very much. The scores from each scale are added up, and can be combined to provide a total score.

    Measured: 8 years

  8. Changes in ILD Severity measured by High Resolution Computed Tomography (HRCT)

    Measured: 8 years

  9. Changes in Pulmonary Function Tests

    Measured: 8 years

  10. Exploratory Quantitative Analysis of High Resolution Computed Tomography (HRCT) Features

    Measured: 8 years

  11. Analysis of Outcomes for Patients Eligible for Study Who Decline Radiotherapy

    Measured: 8 years

  12. Quality of Life measured by the EuroQOL Group EQ-5D-5L questionnaire

    The EQ-5D-5L is a standardized questionnaire used to measure quality of life and health. The first section includes 5 categories: mobility, self-care, usual activities (e.g. work, family), pain/discomfort, and anxiety/depression. Each category contains 5 statements ranging from no problems to extreme problems, where no problems is assigned a code of 1 and extreme problems is assigned a code of 5. Participants are asked to select the statement that best describes their health that day. No score is generated, rather a 5 digit code is generated based on the response provided, which can then be combined into a data set and interpreted in a variety of ways. The second section includes a 20 cm analogue scale from 0 to 100, where 100 is the best health ever imagined and 0 is the worst health imagined. The participant will mark a score on the scale representing the state of their health on that day.

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2018
  2. Study start20 Sep 2018
  3. Primary completion11 Jan 2022
  4. Study completion20 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03485378
Sponsor's protocol ID
ASPIRE-ILD
Acronym
ASPIRE-ILD
Status last verified
Sep 2025
First submitted
7 Mar 2018
Last updated
18 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Palma DA, Bahig H, Hope A, Harrow S, Debenham BJ, Louie AV, Vu TTTT, Filion E, Bezjak A, Campeau MP, Duimering A, Giuliani ME, Laba JM, Lang P, Lok BH, Qu XM, Raman S, Rodrigues GB, Goodman CD, Gaede S, Morisset J, Warner A, Dhaliwal I, Ryerson CJ. Stereotactic Radiation Therapy in Early Non-Small Cell Lung Cancer and Interstitial Lung Disease: A Nonrandomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):575-582. doi: 10.1001/jamaoncol.2023.7269.

    PubMed 38451491

  • Palma DA, Chen H, Bahig H, Gaede S, Harrow S, Laba JM, Qu XM, Rodrigues GB, Yaremko BP, Yu E, Louie AV, Dhaliwal I, Ryerson CJ. Assessment of precision irradiation in early non-small cell lung cancer and interstitial lung disease (ASPIRE-ILD): study protocol for a phase II trial. BMC Cancer. 2019 Dec 11;19(1):1206. doi: 10.1186/s12885-019-6392-8.

    PubMed 31829203

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Ablative Radiotherapy in people with Non Small Cell Lung Cancer and Interstitial Lung Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03485378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in