Pulsed electric field therapy for 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

This study is testing if pulsed electric field therapy can help people with late-stage non-small cell lung cancer who haven't responded to standard treatments feel better and live longer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Energenx Medical LTD. (Industry-sponsored)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05987345 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and clinical benefits of pulsed electric field (PEF) therapy in patients with late-stage non-small cell lung cancer (NSCLC) who have developed resistance to anti-PD-1 monoclonal antibody therapy. Participants will receive PEF treatment on targeted lesions, followed by routine administration of anti-PD-1 therapy if no significant adverse events occur. The study will assess the local control of lesions, progression-free survival (PFS), and overall survival (OS) to determine the efficacy of the combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates include patients over 22 years old with stage III-IV NSCLC who have progressed after first-line anti-PD-1 therapy.

Not a fit: Patients with uncontrolled metastasis to the central nervous system or those who have had recent surgery or local treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who have limited treatment choices.

How similar studies have performed: While the approach of using PEF therapy in conjunction with immunotherapy is relatively novel, similar studies have shown promise in enhancing treatment efficacy in cancer care.

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 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.

Where this trial is running

Guangzhou, Guangdong

• The first Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Shiyue Li, MD — The first Affiliated Hospital of Guanzhou Medical University
• Study coordinator: Sara Xu

Conditions NSCLC; PEF; Immune Checkpoint Inhibitor