NCT05443971

Durvalumab and Grid Therapy for Non-small Cell Lung Cancer in Progression During or After Treatment With PACIFIC Regimen

Restoring Sensitivity to Immunotherapy Post Failure to the Pacific Regimen: A Pilot Study of Combined Durvalumab (MEDI 4736) and Grid Therapy for Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests the safety and side effects of durvalumab and grid therapy in treating patients with non-small cell lung cancer who have progressed during or within 6 months of durvalumab administration for non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Spatially fractionated radiation therapy or "grid therapy" is a technique which delivers high doses of radiation to small areas of the tumor which can lead to more concentrated tumor cell killing and causes less damage to normal tissue. Giving grid therapy with durvalumab may help durvalumab work better to kill tumor cells in patients with non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVE: I. To describe the safety of grid + durvalumab using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. SECONDARY OBJECTIVES: I. Evaluation of overall response rate using Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) in a non-irradiated metastatic lesion. II. Evaluation of development of any additional sites of metastatic disease in the setting of oligorecurrence or local recurrence alone. III. Evaluation of response in the radiated lesion using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. IV. Evaluation of time to change from durvalumab to another systemic therapy. CORRELATIVE OBJECTIVE: I. Monitoring of peripheral blood immunity markers before and after grid therapy. OUTLINE: Patients receive durvalumab intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo grid therapy on day 1. Beginning 7-14 days after grid therapy, patients also undergo palliative radiation therapy for 5 fractions. Additionally, patients undergo blood sample collection at baseline and throughout study. After completion of study treatment, patients are followed up at 30 days and then every 8-12 weeks for up to 5 years from date of registration.

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
RADIATION	Radiation Therapy	Undergo grid therapy
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-06-28
• Completion: 2025-12-17
• First posted: 2022-07-05
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study