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

Launched by ENERGENX MEDICAL LTD. · Aug 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Pulsed Electric Field (PEF) therapy for patients with late-stage non-small cell lung cancer (NSCLC) who have not responded well to a common immunotherapy called anti-PD-1. The main goals of the trial are to check how safe this PEF treatment is, see how well it controls cancer lesions, and understand how it affects the immune system. If patients experience no serious side effects, they will receive standard anti-PD-1 therapy after the PEF treatment.

To be eligible for this trial, participants must be at least 22 years old and have been diagnosed with stage III or IV NSCLC. They should have also previously received anti-PD-1 therapy and experienced disease progression. Participants need to have measurable cancer lesions that meet specific size requirements, and their overall health must be good enough to tolerate the treatment. The trial is currently looking for new participants, and those who join can expect to receive close monitoring and care throughout the study.

Gender

ALL

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.