Clinical trial · Interventional
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
NCT03485378CI-TRIAL-00095370ASPIRE-ILDactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Interstitial Lung Disease | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm: Stereotactic Ablative Radiotherapy
- description
- Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
- interventionNames
- Radiation: Stereotactic Ablative Radiotherapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 4 years
- description
- Time from enrollment to death from any cause
Secondary outcomes (12)
- measure
- Toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
- timeFrame
- 8 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
References
Publications (2)
- DERIVEDPalma 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. PMID 38451491
- DERIVEDPalma 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. PMID 31829203