NCT05987345

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Energenx Medical LTD. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients will will be enrolled to experimental arm and receive standard of care combining with PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely. All kinds of adverse events will be recorded and analyzed to evaluate the safety of the treatment. At the same time, the local control rate of treated lesions, PFS and OS after PEF will be analyzed to evaluate the clinical value of the treatment.

Conditions

• NSCLC

Interventions

Type	Name	Description
DEVICE	PEF	PEF device treated in the trial.
DRUG	Anti-PD-1 monoclonal antibody	Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-08-14
• Last updated: 2024-07-22

Locations

1 site across 1 country: China