Health TrialsbyHealthPanel

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

ConditionNSCLC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorEnergenx Medical LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

More than one measurable lesion according to RECIST 1.1 except PEF targeted lesions.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • PEF

    Device

    PEF device treated in the trial.

  • Anti-PD-1 monoclonal antibody

    Drug

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: PEF treatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Technical success rate of PEF treatment

The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.

Time frame
7 days
2

Incidence of PEF treatment related AE/SAEs

The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0

Time frame
1 month

Secondary outcomes

1

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%.

Time frame
3 months
2

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%.

Time frame
6 months
3

Progression free survival rate at 6 months

Time frame
6 months
4

Overall survival rate at 6 months

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Energenx Medical LTD.

Lead sponsor

Source ClinicalTrials.gov
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