What side effects are associated with this type of intervention?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include radiation therapy, chemotherapy, and immunotherapy. Radiation therapy can cause side effects such as skin irritation, fatigue, and pneumonitis (inflammation of the lung tissue). When combined with chemotherapy, additional side effects may include nausea, vomiting, hair loss, and increased risk of infection due to lowered blood cell counts. Immunotherapy, such as the use of durvalumab, can lead to immune-related side effects like pneumonitis, colitis, hepatitis, and endocrinopathies. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC) that involve radiation therapy and related drugs. Stereotactic ablative radiotherapy (SABR) has been studied and used for treating oligometastatic NSCLC, showing promising results in improving survival rates. Additionally, the combination of radiation therapy with immunotherapy, such as pembrolizumab and atezolizumab, has been explored in various trials, demonstrating enhanced efficacy in treating brain metastases and advanced stages of NSCLC. These treatments aim to deliver targeted radiation to cancer cells while leveraging the immune system to improve patient outcomes.

What other types of research exist?

Promising, novel alternatives to radiation therapy for NSCLC patients include immunotherapy agents such as pembrolizumab, nivolumab, and atezolizumab, as well as targeted therapies like lorlatinib for ALK-positive NSCLC, alectinib for crizotinib-resistant ALK-rearranged NSCLC, LOXO-292 for RET fusion-positive lung cancer, and osimertinib for EGFR-mutated NSCLC. These treatments offer new avenues for managing NSCLC, especially for patients with specific genetic profiles or those who have not responded to traditional therapies.

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Radiation Therapy

SBRT for Non-Small Cell Lung Cancer

Phase 1

Waitlist Available

Led By Meredith Giuliani, MBBS, FRCPC

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-5 years

Awards & highlights

Summary

This trial tests different levels of radiation to find the safest high dose for patients with high-risk ultracentral tumors. It uses a method that adjusts doses based on patient responses to minimize severe side effects.

Who is the study for?

This trial is for adults over 18 with a confirmed or strongly suspected diagnosis of non-small cell lung cancer (NSCLC) that hasn't spread beyond the lungs and is less than 6 cm in size. It's specifically for those whose tumors are very close to central structures like main airways or blood vessels. Participants should be relatively fit (ECOG status 0-2), and not have had prior chemotherapy, thoracic radiotherapy, or surgery for their lung cancer.

What is being tested?

The SUNSET trial tests different doses of Stereotactic Body Radiation Therapy (SBRT) to find the highest safe dose with acceptable side effects for treating ultra-central NSCLC. The study uses an advanced method called TITE-CRM that adjusts treatment based on how earlier patients responded.

What are the potential side effects?

Potential side effects from SBRT may include fatigue, skin reactions at the treatment site, difficulty swallowing if the esophagus is affected, shortness of breath if lung tissue is irritated, and other organ-specific issues depending on where radiation overlaps with nearby structures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximally tolerated dose (MTD)

Secondary study objectives

Patient reported outcome

Quality of Life

Regional nodal progression

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Diarrhea

Anemia

Shortness of Breath

Abdominal pain

Kidney Injury and/or Infection

Pneumonia

Weight Loss

Dyspnea

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Atrial fibrillation with rapid ventricular response

Pleural effusion

colitis

Thrombocytopenia

Respiratory failure

Skin rash

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

1Treatment groups

Experimental Treatment

Group I: Patients with ultra-central NSCLC T1-3 (<6cm) N0 M0Experimental Treatment1 Intervention

Level-1 Dose per fraction: 4Gy Number of fractions: 15 Total Dose: 60 Gy Level 0 Dose per fraction: 6Gy Number of fractions: 10 Total Dose: 60 Gy Level 1 Dose per fraction: 7.5 Gy Number of fractions: 8 Total Dose: 60 Gy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBRT

2014

Completed Phase 2

~1060

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy works by damaging the DNA of rapidly dividing cells, leading to cell death. Targeted therapy inhibits specific molecular pathways essential for cancer cell growth and survival, such as EGFR or ALK mutations. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells. Radiation therapy delivers high-energy particles or waves to destroy or damage cancer cells, which is particularly important for shrinking tumors, alleviating symptoms, and improving survival rates in NSCLC patients.