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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05443971
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — BIOLOGICAL
    Given IV
  • Radiation Therapy — RADIATION
    Undergo grid therapy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Jan 8, 2024
Status verified
Feb 2026
Primary completion
Jun 28, 2025
Completion
Dec 17, 2025

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (durvalumab, grid therapy)
    Patients receive durvalumab 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.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Within 3 months after grid therapy ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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