Radiotherapy for Lung Cancer

(CURB2 Trial)

Not yet recruiting at 33 trial locations

Overseen By Pierre-Olivier Gaudreau

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Must be taking: ICI, Chemotherapy

Must not be taking: Other anti-cancer therapy

Disqualifiers: LCNEC, Leptomeningeal disease, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a special type of radiotherapy called SBRT (a precise and intense radiation treatment) can more effectively prevent lung cancer from growing or spreading compared to the usual mix of cancer drugs alone. It targets individuals with non-small cell lung cancer that has metastasized and shown resistance to initial treatments. Ideal participants are those who have experienced limited cancer progression during or after initial treatment with immunotherapy or chemotherapy. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that certain drug interactions or overlapping side effects could affect your eligibility. It's best to discuss your specific medications with the trial team.

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

Research has shown that SBRT, a type of precise radiation therapy, is generally well-tolerated for treating lung cancer. Studies indicate that SBRT effectively targets and treats cancer in the lungs, with a similar rate of severe side effects as other common radiation therapies.

In everyday practice, most patients receiving SBRT for lung tumors experience manageable side effects. Evidence suggests that short-term side effects and the risk of death within 90 days remain within safe limits for patients with early-stage non-small cell lung cancer (NSCLC). This suggests that SBRT is a relatively safe option compared to other treatments.

Overall, SBRT appears to be a safe choice, providing effective results with side effects that most patients can tolerate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Researchers are excited about the use of Stereotactic Body Radiotherapy (SBRT) for lung cancer because it offers a more precise and intense form of radiotherapy compared to traditional methods. Unlike standard treatments that often require numerous sessions, SBRT delivers high doses of radiation in fewer treatments, potentially reducing the overall treatment time and improving patient convenience. Additionally, SBRT's precision minimizes damage to surrounding healthy tissue, which could lead to fewer side effects. This approach is especially promising for targeting small, well-defined tumors, offering hope for improved outcomes in lung cancer care.

What evidence suggests that SBRT might be an effective treatment for lung cancer?

Research has shown that Stereotactic Body Radiotherapy (SBRT) effectively controls lung tumors. For example, one study found that SBRT successfully controlled 96.7% of tumors after one year and 77.8% after five years. This indicates that SBRT can stop tumors from growing or spreading for many patients. Another study demonstrated that SBRT worked well in real-world settings, providing good control of lung tumors with manageable side effects. In this trial, one group of participants will receive SBRT followed by standard care therapy, while another group will switch to second-line standard care therapy without SBRT. These findings suggest that adding SBRT to standard lung cancer treatments could improve patient outcomes by better controlling tumor growth. ^{3 6 7 8 9}

Who Is on the Research Team?

C. Jillian Tsai

Principal Investigator

University Health Network Princess Margaret Hospital, Toronto, ON Canada

Are You a Good Fit for This Trial?

This trial is for adults with stage IV non-small cell lung cancer without actionable mutations, who've had at least 3 cycles of first-line therapy. They should have stable brain metastases if present, be able to undergo SBRT safely, and fit enough (ECOG status 0-2) to receive second-line standard care.

Inclusion Criteria

I have recovered from side effects of my previous cancer treatment.

I finished my previous cancer treatments at least 6 months ago before starting treatment for metastatic disease.

My lung cancer has spread, lacks certain mutations, and needs specific immune or combo therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiotherapy

Participants receive targeted radiotherapy to block oligoprogression

4-6 weeks

Standard of Care Therapy

Participants receive standard of care therapy following radiotherapy

Variable, based on individual treatment plans

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• SBRT

Trial Overview The study tests whether adding targeted radiotherapy (SBRT) to the usual drug combination can better control lung cancer growth or spread compared to standard treatment alone. Participants will either continue with their current treatment or get the added radiotherapy.

How Is the Trial Designed?

Group I: SBRT/Radiotherapy followed by standard of care therapy Experimental Treatment 1 Intervention

Group II: No SBRT and switch to second-line standard of care therapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

ECOG-ACRIN Cancer Research Group

Collaborator

Trials

122

Recruited

160,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10928908/

Stereotactic body radiotherapy in lung cancer - PubMed Central SBRT-related death occurred in 6 patients after 0.6–19.5 months after treatment [33]. The 4-year results of the study were published by Fakiris ...

2. ro-journal.biomedcentral.com ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02699-4

A prospective outcomes and cost-effective analysis of surgery ... It was designed to compare multidisciplinary treatment selection and outcomes of SBRT to surgery using prospective data on patient satisfaction, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016781402504784X

121 - stereotactic body radiation therapy for octogenarians ... SBRT demonstrated high efficacy in local tumour control, with a 1-year LC rate of 96.7% and a 5-year LC rate of 77.8%. The mean LC was 4.99 years, suggesting ...

4. ascopubs.org ascopubs.org/doi/10.1200/GO.22.00061

Real-World Evidence of Health Outcomes Related to Lung ... Our results indicate that SBRT is effective (high local control and acceptable toxicity) for treating malignant lung lesions in a real-world scenario in Latin ...

5. tlcr.amegroups.org tlcr.amegroups.org/article/view/43005/html

Four-year follow-up outcomes after stereotactic body radiation ... Conclusions: SBRT with a BED 100 Gy in 4–10 fractions is effective and acceptable for treating patients with central early-stage NSCLC. Further studies are ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6460233/

Long-term Clinical Outcomes and Safety Profile of SBRT for ... SBRT for central lung tumors offers very high rates of LC and acceptable rates of severe toxicity comparable with peripheral tumors.

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

Real-World Acute Toxicity and 90-Day Mortality in Patients ... This study aimed to uncover the real-world incidence of acute toxicity and 90-day mortality in patients with SBRT-treated stage I NSCLC and ...

8. redjournal.org redjournal.org/article/S0360-3016(24)00508-X/fulltext

Safety and Efficacy of Stereotactic Body Radiation Therapy ... A total of 154 patients received SBRT to 162 ultracentral lesions during our study period, with baseline characteristics described in Table 1.

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

Stereotactic body radiotherapy in lung cancer Both in terms of 3-year estimated OS (SBRT: 95%, lobectomy: 79%) and recurrence-free survival (SBRT: 86%, lobectomy: 80%), patients who received ...