SABR for Lung Cancer

(SUPPRESS-NSCLC Trial)

Recruiting at 1 trial location

Overseen By Silvine Benth

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must be taking: ICI, TKI

Disqualifiers: Pregnancy, Breastfeeding, Spinal cord compression, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for treating metastatic non-small cell lung cancer (NSCLC). It compares standard treatments with an experimental technique called stereotactic ablative radiotherapy (SABR), which targets cancer spots with high doses of radiation while continuing current drug treatments. Suitable participants are those with this specific lung cancer, having 1-5 cancer spots outside the brain, and who have not responded to ongoing drug treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, participants will continue their current systemic therapy while receiving the trial treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SABR (Stereotactic Ablative Radiotherapy) is usually well-tolerated by patients. Studies have found that combining SABR with treatments like chemotherapy or immunotherapy is generally safe, with most people not experiencing severe side effects.

One study found that using SABR with the drug durvalumab resulted in manageable side effects. Another report noted that patients with early-stage lung cancer treated with SABR did not experience serious short-term side effects, and their survival rates were promising. This suggests that SABR could be a safe option for treating certain types of lung cancer.

Overall, while no treatment is without risks, evidence suggests that SABR is generally safe for people with lung cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about SABR (Stereotactic Ablative Radiotherapy) for lung cancer because it offers a precise and targeted approach to treating tumors. Unlike traditional radiotherapy, which can affect surrounding healthy tissue, SABR delivers high doses of radiation directly to the cancerous lesions with pinpoint accuracy. This means fewer side effects and potential for better outcomes. Additionally, for patients with oligoprogressive disease, SABR can be combined with ongoing systemic therapies, providing a more comprehensive treatment strategy that might improve survival rates and quality of life.

What evidence suggests that SABR might be an effective treatment for metastatic non small cell lung cancer?

Research shows that stereotactic ablative radiotherapy (SABR) could benefit lung cancer patients. In this trial, some participants will receive SABR, which earlier studies have found to be safe and effective for certain lung cancers, such as stage I metachronous lung cancer. Specifically, patients who received SABR with chemotherapy showed good survival rates: 80.5% were alive after three years, and 46% after five years. The treatment has a low rate of side effects in the first 90 days, with only 3.8% of patients experiencing negative effects and 1.7% passing away from any cause. This evidence suggests that SABR could be a good option for patients with specific lung cancer conditions. Meanwhile, other participants in this trial will receive standard care treatments, which may include systemic therapy or supportive care. ^{1 5 6 7 8}

Who Is on the Research Team?

Bertrand Routy, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Houda Bahig, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for adults with metastatic non-small cell lung cancer who have limited progression in up to 5 body sites while on current cancer drugs. They must be able to consent, have a performance status of 0-3, and not be pregnant or breastfeeding. Lesions must be smaller than 5 cm and not involve the GI tract.

Inclusion Criteria

My cancer has spread to 1-5 spots outside the brain, affecting up to 3 organs, and is under 5cm.

My cancer has spread in a limited way while on immunotherapy or targeted therapy.

Ability to provide written informed consent

Exclusion Criteria

Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.

My cancer has spread to my spine or digestive system.

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either standard of care or receive stereotactic ablative radiotherapy to oligoprogressive lesions while continuing current systemic therapy

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of progression-free survival and overall survival

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SABR
• Standard of care

Trial Overview

The study compares standard care options versus adding stereotactic ablative radiotherapy (SABR) to existing systemic therapy for patients whose lung cancer has progressed but remains limited. Patients are randomly assigned to either continue/change their current treatment or receive SABR alongside it.

How Is the Trial Designed?

Group I: Experimental SABR arm Experimental Treatment 1 Intervention

Definitive SABR to oligoprogressive lesions + continue current systemic therapy

Group II: Standard of care Active Control 1 Intervention

Switch to subsequent systemic therapy line, best supportive care or continue current systemic line

SABR is already approved in European Union, United States, United Kingdom for the following indications:

Approved in European Union as SABR for:

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

Approved in United States as SABR for:

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

Approved in United Kingdom as SABR for:

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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

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]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative body radiotherapy (SABR) is a significant advancement in radiotherapy that has been shown to improve tumor control and overall survival in patients with lung tumors.

The review highlights the current evidence supporting the efficacy of SABR for both primary and secondary lung tumors, along with ongoing trials that may further validate its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. Goldsmith, C., Gaya, A.[2022]

Stereotactic ablative body radiotherapy (SABR) is now the standard treatment for early-stage non-small-cell lung cancer (NSCLC) in patients who cannot undergo surgery, highlighting its efficacy in this patient population.

The review also discusses the safety profile of SABR, including reported toxicity rates, and explores its potential use in combination with other therapies for improved outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. Murray, P., Franks, K., Hanna, GG.[2022]

The introduction of stereotactic ablative body radiotherapy (SABR) for stage I non-small-cell lung cancer (NSCLC) at a Scottish cancer center has led to improved median survival rates, increasing from 32.5 months before SABR was available to 48.8 months after its establishment.

SABR has not only improved survival outcomes but also increased the proportion of patients receiving radical therapy, particularly among younger and healthier patients, indicating its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Impact of SABR on Stage I Non-Small-Cell Lung Cancer Outcomes at a Scottish Cancer Centre. Stares, M., Lewis, G., Vallet, M., et al.[2023]

The iSABR trial demonstrated that individualized stereotactic ablative radiotherapy (SABR) for lung tumors resulted in high local control rates, with freedom from local recurrence at 1 year ranging from 94% to 97% across different patient groups.

The trial showed a low incidence of severe toxic effects (only 5%), indicating that personalized dosing strategies can minimize risks while maintaining effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. Gensheimer, MF., Gee, H., Shirato, H., et al.[2023]

In a study of 102 patients treated with stereotactic ablative radiation therapy (SABR) for early-stage non-small-cell lung cancer, a significant correlation was found between higher Biological Equivalent Doses (BED) over 300 Gy and the development of radiological changes such as organizing pneumonia and lung affectation over a 2-year follow-up.

Radiological changes were more pronounced in patients receiving BEDs greater than 300 Gy to healthy lung volumes of at least 30 cc, suggesting that these findings could inform future radiotherapy dose constraints to minimize pulmonary toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. Cases, C., Benegas, M., Sánchez, M., et al.[2023]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., et al.[2022]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5601509/

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Although not statistically significant, the 3- and 5- year survival rates for the patients who received SABR plus adjuvant chemotherapy were 80.5% and 46%, ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0167814024007096

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The study included reports that assessed the outcomes of SABR treatment in patients with LA-NSCLC. Studies evaluating SBRT as a boost following primary ...

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ro-journal.biomedcentral.com/articles/10.1186/s13014-023-02286-5

Comparison of outcome after stereotactic ablative ...

In conclusion, our results show that SABR is safe and effective treatment for stage I metachronous lung cancer, with outcomes not ...

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jto.org

jto.org/article/S1556-0864(24)00763-9/fulltext

Historical Versus Modern Data of Stereotactic Ablative ...

The results support the utilization of SABR for these patients (with a 90-day toxicity rate of 3.8% and a 90-day all-cause mortality of 1.7%), but more ...

5.

por-journal.com

por-journal.com/journals/pathology-and-oncology-research/articles/10.3389/pore.2024.1611709/full

Stereotactic body radiotherapy in lung cancer

The results of a total of 102 patients after a median follow-up of 37 months showed no significant difference between the two groups either in ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301623003255

Safety and Efficacy Results From iSABR, a Phase 1 Study ...

We are the first to report prospective data to support an acceptable per protocol toxicity profile with combination lung SABR and durvalumab in medically ...

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jto.org

jto.org/article/S1556-0864(24)00684-1/fulltext

Real-World Acute Toxicity and 90-Day Mortality in Patients ...

Real-World Acute Toxicity and 90-Day Mortality in Patients With Stage I NSCLC Treated With Stereotactic Body Radiotherapy. Peter S.N. van Rossum ...

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jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2809582

Individualized Stereotactic Ablative Radiotherapy for Lung ...

Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy ...