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

NSCLC Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987345
• Other study ID #: LCFIM-001
• Status: Recruiting
• Phase: N/A
• Start date: July 6, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: August 2023
• Source: Energenx Medical LTD.
• Contact: Jiajie Zhang, MD
• Phone: +86 18621207399
• Email: jj.zhang[@]energenxmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients over 18 years old with pathologically confirmed non-small cell lung cancer.

2. Patients got benefit from anti PD-1 immunotherapy prior to disease progression.

3. Lesions to be ablated must be = 3cm in longest diameter.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• NSCLC

Intervention

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.

Locations

Country	Name	City	State
China	The first Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Energenx Medical LTD.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Progression free survival rate at 6 months		6 months
Secondary	Overall survival rate at 6 months		6 months
Secondary	Overall survival rate at 12 months		12 months