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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC
• Intervention / Treatment: Device: PEF; Drug: Anti-PD-1 monoclonal antibody

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Xu; Phone Number: +86 021 52230973; Email: info@energenxmedical.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Li Shiyue, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 immune system diseases or being treated with immunosuppressants.
6. Severe abnormality of liver and kidney function, which was evaluated by the researchers as unsuitable for admission.
7. 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.
8. Accompanied by infectious diseases that cannot be effectively controlled.
9. Suffered from other severe lung diseases (including interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis with emphysema, atelectasis, etc.)
10. 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.
11. Patients who are participating in other clinical trials.
12. With a cardiac pacemaker or metal implant in the chest.
13. Women who are pregnant or lactating, or who plan to become pregnant during the study.
14. The researchers determined that there were other conditions in which patients were not suitable for enrollment.
15. Patients who have a history of receiving non-first-line anti PD-1 immunotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Overall survival rate at 12 months		12 months
Progression free survival rate at 6 months		6 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%.	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
Overall survival rate at 6 months		6 months

Collaborators and Investigators

• Sponsor: Energenx Medical LTD.
• Investigators: Principal Investigator: Shiyue Li, MD, The first Affiliated Hospital of Guanzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: NSCLC; PEF; Immune Checkpoint Inhibitor(ICI)
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Antibodies, Monoclonal
• Other Study ID Numbers: LCFIM-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No