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

Study Overview
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Brief Summary
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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.

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

Conditions
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NSCLC

Intervention / Treatment
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* Device: PEF
* Drug: Anti-PD-1 monoclonal antibody


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old with pathologically confirmed non-small cell lung cancer. Patients got benefit from anti PD-1 immunotherapy prior to disease progression. Lesions to be ablated must be ≤ 3cm in longest diameter. More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions. Eastern Cooperative Oncology Group(ECOG) performance status 0-1 Life expectancy ≥3 months Fully understand the treatment plan and sign the informed consent form voluntarily. Exclusion Criteria: Patients should be excluded if they received surgery within 30 days. Patients should be excluded if they received any form of local treatment within 30 days. Accompanied by uncontrolled metastasis of the central nervous system. Have a history of severe adverse reactions to ICI. With uncontrolled immune system diseases or being treated with immunosuppressants. Severe abnormality of liver and kidney function, which was evaluated by the researchers as unsuitable for admission. Patients with abnormal blood coagulation and antiplatelet therapy due to cardiovascular and cerebrovascular diseases should be discontinued one week before PEF treatment according to the evaluation of clinicians. Accompanied by infectious diseases that cannot be effectively controlled. Suffered from other severe lung diseases (including interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, etc.) Patients who had severe cardiac dysfunction and had a history of arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias, a history of degree II or III atrioventricular block, and sinus bradycardia with a heart rate of less than 45 beats per minute. Patients who are participating in other clinical trials. With a cardiac pacemaker or metal implant in the chest. Women who are pregnant or lactating, or who plan to become pregnant during the study. The researchers determined that there were other conditions in which patients were not suitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEF treatment<br>All of participants who signed the Informed Consent Form(ICF) and meet all of inclusion and exclusion criterial will be enrolled to experimental arm. PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely. | Device: PEF<br>* PEF device treated in the trial.<br>Drug: Anti-PD-1 monoclonal antibody<br>* Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate of PEF treatment | The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery. | 7 days | 
| Incidence of PEF treatment related AE/SAEs | The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0 | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local control of ablated lesions by CT | Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%. | 3 months | 
| Local control of ablated lesions by CT | Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%. | 6 months | 
| Progression free survival rate at 6 months |  | 6 months | 
| Overall survival rate at 6 months |  | 6 months | 
| Overall survival rate at 12 months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, PEF, Immune Checkpoint Inhibitor(ICI)