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

NCT05987345 | Recruiting

• 1 other identifier: LCFIM-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Keywords

NSCLC; PEF; Immune Checkpoint Inhibitor(ICI)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Local control of ablated lesions by CT

  3 months

• Local control of ablated lesions by CT

  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

Study Arms (1)

PEF treatment

EXPERIMENTAL

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; Drug: Anti-PD-1 monoclonal antibody

Interventions

PEF DEVICE

PEF device treated in the trial.

PEF treatment

Anti-PD-1 monoclonal antibody DRUG

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

PEF treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 22 years old with pathologically confirmed non-small cell lung cancer stage III-IV.
• Patients received first-line anti PD-1 immunotherapy and had disease progression.
• 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.
• 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.

You may not qualify if:

• 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.
• Patients who have a history of receiving non-first-line anti PD-1 immunotherapy.

Sponsors & Collaborators

• Energenx Medical LTD.: lead

Study Sites (1)

The first Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Interventions

spartalizumab

Study Officials

• Shiyue Li, MD

  The first Affiliated Hospital of Guanzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Xu

CONTACT

+86 021 52230973; info@energenxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 14, 2023
• Study Start: July 6, 2023
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

CN (1)