The AFFINITY study has finished enrolling participants to evaluate the Aliya pulsed electric field system in patients with stage IV non–small cell lung cancer or lung metastases who are not candidates for surgery.
Holographic concept of lung cancer display, lung disease, treatment of lung cancer: © catalin - stock.adobe.com
Trial Name: A Clinical Study of Aliya™ Pulsed Electric Fields (PEF) Delivered Prior to Standard of Care Treatment for Advanced Cancer
ClinicalTrials.gov Identifier: NCT05890872
Sponsor: Galvanize Therapeutics, Inc.
Completion Date: July, 2025
The AFFINITY study (NCT05890872) assessing Aliya pulsed electric field (PEF) ablation in patients with stage IV non–small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates has completed enrollment.1
Aliya works by delivering high voltage, short duration electrical energy locally, which changes the transmembrane potential of cells and leads to loss of homeostasis. This can induce nonthermal programmed cell death without denaturing cellular proteins or the extracellular matrix. Preclinical and prior clinical feasibility studies of Aliya show the potential of this process in releasing antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation.
Investigators are evaluating the safety of adding Aliya PEF to standard-of-care (SOC) therapies for the treatment of patients with advanced disease in this study of 30 patients. Aliya PEF will be delivered either bronchoscopically or percutaneously. Additionally, experts are evaluating immune stimulation and treatment effects with the agent.
"Completing enrollment in AFFINITY is a significant milestone towards our goal of providing patients with solid tumors a biology-based therapy that extends beyond focal ablation," said Jonathan Waldstreicher, MD, founder and chief executive officer of Galvanize Therapeutics, in a press release."We look forward to reporting the results next year."
With the new INUMI™ Flex needle, Aliya can be delivered percutaneously or endoscopically, and more than 1000 patients have been treated commercially and in clinical trials in the US using Aliya PEF to date.
Both the Aliya PEF System and the INUMITM Flex needle are 510(k) cleared in the US for the surgical ablation of soft tissue. However, they are not currently commercially available for patients anywhere else.
"I'm excited to see the study results for this new technology", said David DiBardino, MD, associate director of clinical research, section of interventional pulmonology and associate professor of clinical medicine, pulmonology, allergy, and critical care at University of Pennsylvania, and investigator in the AFFINITY trial, in a press release. "It's great to be able to diagnose and ablate in the same procedure; however, the added potential to stimulate the patient's immune system to create a systemic response represents a breakthrough for patients with metastatic disease."
AFFINITY is evaluating the safety of delivering Aliya PEF in patients with metastatic cancer within the lungs or stage IV NSCLC. Patients are those who are treatment naive and indicated for first-line SOC therapy.2
Enrollment in the trial is open to patients aged 22 years and older with a radiologically documented suspected or confirmed tumor that is at least 5 cm in longest diameter and suitable per study procedural guidelines for treatment with PEF, as evaluated by the investigator. Patients must be eligible to receive first-line SOC therapy, must not be a candidate for surgery with curative intent, have refused surgery, and have a life expectancy of at least 6 months.
The primary end points of the study are to assess device- and procedure-related serious adverse events and the percentage of patients whose SOC cancer treatment was not canceled or postponed. Secondary end points include the frequency with which physicians can deliver PEF energy to intended targets, anesthesia type usage, anatomic lung region treated with PEF, and time to initiate first-line SOC therapy after PEF treatment.
The study is being conducted in Florida, Minnesota, New York, North Carolina, and Pennsylvania, and has an estimated study completion date of July 2025.
