Precision Radiotherapy for Non-Small Cell Lung Cancer

(ASPIRE-ILD Trial)

Recruiting at 5 trial locations

Overseen By David Palma, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must be taking: Anti-fibrotic agents, steroids

Must not be taking: Immunosuppressive drugs, radiosensitive drugs

Disqualifiers: Prior invasive malignancy, prior thoracic radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications. If you are on immunosuppressive drugs like mycophenolate, azathioprine, cyclophosphamide, or rituximab, you must stop them 2 weeks before and after the treatment. However, you can continue taking anti-fibrotic agents or steroids if they are part of your current treatment for lung disease.

Is stereotactic body radiation therapy (SBRT) safe for treating non-small cell lung cancer?

Research shows that SBRT is generally safe for treating early-stage non-small cell lung cancer, with studies reporting acceptable levels of side effects and good tumor control. However, some adverse effects like lung and chest wall issues have been noted, and rare cases of vertebral fractures have been reported. ^{1 2 3 4 5}

How is the treatment Stereotactic Ablative Radiotherapy different from other treatments for non-small cell lung cancer?

Stereotactic Ablative Radiotherapy (SBRT) is unique because it delivers highly precise, high-dose radiation to the tumor in a few sessions, making it an effective option for patients with early-stage non-small cell lung cancer who cannot or choose not to undergo surgery. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for non-small cell lung cancer?

Research shows that Stereotactic Body Radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC), especially for patients who cannot have surgery. Studies indicate that SBRT can improve survival rates and control the disease well in these patients. ^{10 11 12 13 14}

Who Is on the Research Team?

Alexander Louie, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Chris Ryerson, MD

Principal Investigator

University of British Columbia

David Palma, MD

Principal Investigator

London Health Sciences Centre, Lawson Health Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage Non-Small Cell Lung Cancer (NSCLC) and Interstitial Lung Disease (ILD). They should not be candidates for surgery, have a life expectancy of more than 6 months, and an ECOG performance status of 0-3. Excluded are those with other recent cancers, prior thoracic radiotherapy, or taking certain drugs that affect radiotherapy.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work.

My cancer is early stage, with a tumor size of 5 cm or less and hasn't spread.

I am diagnosed with non-small cell lung cancer, but it's not confirmed by pathology.

Exclusion Criteria

I am not taking any medications known to increase sensitivity to radiation.

I plan to only receive the study treatment unless my disease gets worse.

I plan to continue my current treatment for lung fibrosis while in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stereotactic Ablative Radiotherapy (SABR) for early non-small cell lung cancer and interstitial lung disease

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Long-term follow-up

Participants' quality of life and overall survival are assessed using standardized questionnaires

8 years

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Ablative Radiotherapy

Trial Overview The study tests Stereotactic Ablative Radiotherapy (SABR) on NSCLC patients with ILD to see its effectiveness and safety. Participants are grouped based on their ILD-GAP index to assess outcomes specific to their condition's severity.

How Is the Trial Designed?

Group I: Treatment Arm: Stereotactic Ablative Radiotherapy Experimental Treatment 1 Intervention

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

Stereotactic Ablative Radiotherapy is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United States as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Approved in United Kingdom as Stereotactic Ablative Radiotherapy for:

• Early-stage non-small cell lung cancer
• Liver cancers
• Kidney cancers
• Bone metastasis
• Spinal metastasis
• Prostate cancers

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

London Health Sciences Centre

Collaborator

Trials

151

Recruited

60,400+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

University of Western Ontario, Canada

Collaborator

Trials

168

Recruited

320,000+

Published Research Related to This Trial

Lung stereotactic body radiation therapy (SBRT) is an effective treatment option for early-stage non-small cell lung cancer (NSCLC) and is increasingly being used for more advanced cases.

The review highlights current treatment recommendations and planning for SBRT, indicating its growing role in managing lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. Rehman, S., Roach, MC., Bradley, JD., et al.[2018]

In a study of 12,055 patients with early-stage non-small cell lung cancer (NSCLC), adjuvant chemotherapy after stereotactic body radiation therapy (SBRT) improved overall survival (OS) for patients with squamous cell carcinoma (SCC) and large cell carcinoma, but not for those with adenocarcinoma.

For tumors smaller than 4 cm, adjuvant chemotherapy was associated with worse OS across all histologies, indicating that the effectiveness of chemotherapy may depend on tumor size and type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of histology in the outcomes of patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) and adjuvant chemotherapy. Ernani, V., Appiah, AK., Baine, MJ., et al.[2021]

Stereotactic body radiotherapy (SBRT) is an effective treatment for patients with stage I non-small cell lung cancer (NSCLC) who cannot undergo surgery, with a median overall survival of 30 months for T1 tumors and 26 months for T2 tumors based on a study of 723 patients.

Higher biological equivalent doses (BED10) of SBRT significantly improve local control rates for T2 tumors, with a local failure rate dropping from 32% to 8% as the BED10 increases from <105 Gy to ≥150 Gy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. Davis, JN., Medbery, C., Sharma, S., et al.[2022]

In a study of 92 patients with early-stage non-small cell lung cancer (NSCLC) tumors measuring ≥5 cm, stereotactic body radiotherapy (SBRT) demonstrated high local control rates of 95.7% at 1 year and 73.2% at 2 years, indicating its efficacy for larger tumors.

The treatment was found to be safe, with only 1% of patients experiencing grade 3 dermatitis and 4% experiencing grade 3 radiation pneumonitis, suggesting that serious side effects are relatively rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors. Verma, V., Shostrom, VK., Kumar, SS., et al.[2018]

Stereotactic body radiation therapy (SBRT) demonstrated a 3-year overall survival rate of 59.9% for inoperable patients and 76.5% for operable patients with T1N0M0 non-small cell lung cancer, indicating its efficacy as a treatment option.

The treatment was associated with low rates of severe toxicities, with only 10 patients experiencing grade 3 and 2 patients experiencing grade 4 toxicities, suggesting that SBRT is a safe alternative to surgery for early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. Nagata, Y., Hiraoka, M., Shibata, T., et al.[2022]

Stereotactic body radiation therapy (SBRT) demonstrated high effectiveness in treating early-stage non-small cell lung cancer (NSCLC), with 3-year local control, progression-free survival, and overall survival rates of 91%, 55%, and 71%, respectively, based on a study of 55 patients with 59 lesions.

The treatment was associated with minimal toxicity, with only a few cases of grade 2 pneumonitis and chest wall tenderness, indicating that SBRT is a safe option for patients who are not surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer: A Retrospective, Single-Center Study of 55 Patients. Bhandari, RP., Stanford, JD., Packianathan, S., et al.[2018]

In a study of 145 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT), the treatment demonstrated a high local control rate with only 24.1% experiencing disease recurrence over a median follow-up of 65.6 months.

SBRT was associated with low toxicity, as only 3.4% of patients experienced grade 3 adverse events, and no patients suffered from severe (grade 4 or 5) toxicities, indicating that it is a safe treatment option for this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up after stereotactic body radiotherapy for medically inoperable early-stage non-small cell lung cancer: a multicenter study. Guo, Y., Zhu, Y., Zhang, R., et al.[2023]

A 68-year-old woman treated with stereotactic body radiation therapy (SBRT) for lung metastases experienced pathological vertebral fractures ten months post-treatment, highlighting a previously unreported adverse effect of SBRT.

Despite achieving a complete response of the metastatic disease without signs of radiation pneumonitis, the case emphasizes the need for oncologists to consider the risk of bone toxicity, particularly in older patients with potential low bone mineral density (BMD).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. Rodríguez-Ruiz, ME., San Miguel, I., Gil-Bazo, I., et al.[2022]

Stereotactic body radiation therapy (SBRT) is an effective treatment for early-stage non-small cell lung cancer (NSCLC), providing precisely targeted radiation doses to tumors, especially for patients who cannot undergo surgery.

The review highlights the importance of SBRT in both medically inoperable cases and its potential role in operable early-stage NSCLC, indicating its growing significance in cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Early-Stage Lung Cancer. Maquilan, G., Timmerman, R.[2018]

Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.

Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Lung Stereotactic Body Radiation Therapy. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The impact of histology in the outcomes of patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic body radiation therapy (SBRT) and adjuvant chemotherapy. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for early-stage non-small cell lung cancer: clinical outcomes from a National Patient Registry. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Improved Survival Outcomes in Medically Fit Patients With Early-Stage Non-Small-Cell Lung Cancer Undergoing Stereotactic Body Radiotherapy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Multi-institutional experience of stereotactic body radiotherapy for large (≥5 centimeters) non-small cell lung tumors. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Prospective Trial of Stereotactic Body Radiation Therapy for Both Operable and Inoperable T1N0M0 Non-Small Cell Lung Cancer: Japan Clinical Oncology Group Study JCOG0403. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Stage I Non-Small Cell Lung Cancer: A Retrospective, Single-Center Study of 55 Patients. [2018]

8. China pubmed.ncbi.nlm.nih.gov

Five-year follow-up after stereotactic body radiotherapy for medically inoperable early-stage non-small cell lung cancer: a multicenter study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Pathological vertebral fracture after stereotactic body radiation therapy for lung metastases. Case report and literature review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for patients with lung cancer previously treated with thoracic radiation. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiation Therapy for Early-Stage Lung Cancer. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Mortality after radiotherapy or surgery in the treatment of early-stage non-small-cell lung cancer: a population-based data analysis in the clinical cancer registry of Brandenburg-Berlin. [2023]

13. England pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]

14. United States pubmed.ncbi.nlm.nih.gov

Stereotactic Body Radiotherapy for Large (> 5 cm) Non-Small-Cell Lung Cancer. [2018]