NCT06660407

Grid Radiation Therapy for the Treatment of Stage IV Non-Small Cell Lung Cancer

Grid Radiotherapy for Advanced Non-Small Cell Lung Cancer at the Time of Progression on Immune Checkpoint Inhibition

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests the safety and effectiveness of the combination of grid radiation therapy and standard of care (SOC) immunotherapy in treating patients with stage IV non-small lung cancer (NSCLC). Conventional radiation therapy treatments typically deliver the same radiation dose to the entire tumor. Spatially fractionated radiation therapy or grid therapy is approved and a technique which permits the delivery of high doses of radiation to small regions of the tumor which can lead to enhanced tumor cell killing. Grid therapy has been shown to produce dramatic relief of severe symptoms, significant tumor regression (decrease in the size of a tumor), and above average local control rates often exceeding those expected with conventionally delivered radiation treatments, all with minimal associated toxicity. Immunotherapy has become combined into treating patients, which has led improvements in survival and quality of life. Immunotherapy is now the cornerstone of SOC therapy for stage IV NSCLC. Grid radiation therapy combined with immunotherapy may be safe and effective in treating patients with stage IV NSCLC.

Detailed description

PRIMARY OBJECTIVE: I. To describe the safety and toxicity of grid + immunotherapy in stage IV NSCLC using any Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. SECONDARY OBJECTIVE: I. Evaluation of objective response rate using Immune-based Response Evaluation Criteria in Solid Tumors (iRECIST) in non-irradiated lesion(s) after grid therapy in the setting of ongoing immunotherapy. CORRELATIVE RESEARCH: I. Monitoring of peripheral blood T cell activation and immunity markers before and after grid therapy. II. Evaluation of objective response rate using RECIST in the irradiated lesion after grid therapy. III. Evaluation of time to change in systemic therapy. IV. Evaluation of overall survival. OUTLINE: Patients undergo grid radiation therapy over a single fraction on day 1 and palliative radiation therapy over 5 fractions on days 2 and -1 post-grid in the absence of disease progression or unacceptable toxicity. Patients also receive SOC immunotherapy and undergo computed tomography (CT) at the discretion of the physician and undergo blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days then every 8-12 weeks and every 3 months up to 5 years.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Immunotherapy	Given immunotherapy
RADIATION	Palliative Radiation Therapy	Undergo palliative radiation therapy
RADIATION	Spatially-fractionated Radiation Therapy	Undergo grid radiation therapy

Timeline

• Start date: 2024-11-14
• Primary completion: 2027-01-10
• Completion: 2027-01-10
• First posted: 2024-10-28
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States