RecruitingNot ApplicableNCT05987345

Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer

Safety and Clinical Efficacy Evaluation of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer


Sponsor

Energenx Medical LTD.

Enrollment

10 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to verify the safety and clinical benefit of pulsed electric field(PEF) treatment of metastatic non-small cell lung cancer(NSCLC) patients with acquired resistance to anti programmed cell death protein 1(PD-1) monoclonal antibody therapy. The main questions it aims to answer are: * Safety of PEF treatment of metastatic NSCLC patients. * Control of ablated and other targeted lesions. * Local and peripheral immunoregulation effect. PEF energy will be delivered to preselected lesions of participants, then anti PD-1 will be routinely administrated if no adverse event(AE)/serious adverse event(SAE) which need medical intervention occurs.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new treatment called pulsed electric field (PEF) therapy — a non-thermal energy-based technique to destroy tumors — in people with late-stage non-small cell lung cancer (NSCLC) whose cancer progressed after immunotherapy. **You may be eligible if...** - You are over 22 years old - You have confirmed non-small cell lung cancer at stage III or IV - You previously received immunotherapy (anti-PD-1) as first-line treatment, and your cancer has since progressed - The tumor to be treated is 3 cm or smaller **You may NOT be eligible if...** - You have not received prior immunotherapy - Your tumor is larger than 3 cm - Your cancer is not non-small cell lung cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPEF

PEF device treated in the trial.

DRUGAnti-PD-1 monoclonal antibody

Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.


Locations(1)

The first Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

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NCT05987345


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