← Back to Clinical Trials
Recruiting NCT05987345

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

Trial Parameters

Condition NSCLC
Sponsor Energenx Medical LTD.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 22 Years
Max Age N/A
Start Date 2023-07-06
Completion 2024-07-31
Interventions
PEFAnti-PD-1 monoclonal antibody

Brief 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 Criteria

Inclusion Criteria: 1. Patients over 22 years old with pathologically confirmed non-small cell lung cancer stage III-IV. 2. Patients received first-line anti PD-1 immunotherapy and had disease progression. 3. Lesions to be ablated must be ≤ 3cm in longest diameter(LD). \* The leison to be ablated can be ≤ 5cm in LD, if evaluated as possible with multiple energy delivery in a single session. 4. More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions. 5. Eastern Cooperative Oncology Group(ECOG) performance status 0-1 6. Life expectancy ≥3 months 7. Fully understand the treatment plan and sign the informed consent form voluntarily. Exclusion Criteria: 1. Patients should be excluded if they received surgery within 30 days. 2. Patients should be excluded if they received any form of local treatment within 30 days. 3. Accompanied by uncontrolled metastasis of the central nervous system. 4. Have a history of severe adverse reactions to ICI. 5. With uncontrolled imm

Related Trials