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

Sponsor

Energenx Medical LTD. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05987345

Collaborator

(none)

Enrollment

Location

Arm

12.8

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NSCLC	Device: PEF Drug: Anti-PD-1 monoclonal antibody	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Jul 31, 2024

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEF treatment 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 PEF device treated in the trial. Drug: Anti-PD-1 monoclonal antibody Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.

Arm

Intervention/Treatment

Experimental: PEF treatment

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

PEF device treated in the trial.

Drug: Anti-PD-1 monoclonal antibody

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Local control of ablated lesions by CT [3 months]
Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
Local control of ablated lesions by CT [6 months]
Compared with the baseline CT scan before treatment, the maximum diameter of the ablated lesion decreased, remained unchanged or increased by less than 20%.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.