The goal of this clinical trial is to evaluate safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV non-small cell lung cancer (NSCLC) who are treatment-naïve and indicated for first-line standard of care (SOC) cancer therapy.
The Aliya Treatment System is designed to deliver therapeutic PEF energy to target tissues, via either a percutaneous or bronchoscopic approach. In order to evaluate the therapeutic potential of PEF delivered via the Aliya Treatment System as an interventional treatment, this clinical trial will evaluate the safety of delivering Aliya PEF in non-surgical advanced stage disease treatment-naïve patients indicated for diagnostic biopsy and first line (1L) standard of care (SOC) therapy. Additionally, this study will examine the safety of adding PEF treatment to the care pathway for patients with metastatic cancer to the lung or stage IV NSCLC and further assess the potential immune modulation and treatment effect of PEF for providing benefit to oncological patients, as outlined below.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Percutaneous or Endobronchial PEF
Mayo Clinic
Jacksonville, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Weill Cornell Medicine | New York-Presbyterian
New York, New York, United States
FirstHealth of the Carolinas, Inc.
Pinehurst, North Carolina, United States
Device and Procedure related serious adverse events
The rate of study device-related and/or PEF procedure-related serious adverse events (SAEs)
Time frame: 30 days post PEF
Percentage of subjects whose SOC cancer treatment was not cancelled or postponed
The percentage of subjects whose SOC cancer treatment was not cancelled or postponed due to a PEF device- or procedure-related AE
Time frame: 1 year Post PEF
Procedural success
The frequency with which physicians can deliver PEF energy to intended targets
Time frame: Day of procedure
Anesthesia Type Usage
Anesthesia Type Usage
Time frame: During PEF procedure
PEF Target Location
Anatomic lung region treated with PEF
Time frame: During PEF procedure
Initiation of first-line (1L) SOC therapy following PEF treatment
Time to initiate first-line (1L) SOC therapy following PEF treatment
Time frame: 12 months
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University of Pennsylvania
Philadelphia, Pennsylvania, United States