NSCLCNCT05987345
Trial of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
A study testing PEF and Anti-PD-1 monoclonal antibody in people with NSCLC, run by Energenx Medical LTD. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- PEF and Anti-PD-1 monoclonal antibody
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Li Shiyue, MD
About this study
Official title: Safety and Clinical Efficacy Evaluation of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
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.
Read the detailed description
Eligible patients will will be enrolled to experimental arm and receive standard of care combining with PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely.
All kinds of adverse events will be recorded and analyzed to evaluate the safety of the treatment. At the same time, the local control rate of treated lesions, PFS and OS after PEF will be analyzed to evaluate the clinical value of the treatment.
- Conditions
- NSCLC
- Being tested
- PEF, Anti-PD-1 monoclonal antibody
- Keywords
- NSCLC, PEF, Immune Checkpoint Inhibitor(ICI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEFDevice
PEF device treated in the trial.
Anti-PD-1 monoclonal antibodyDrug
Anti-PD-1 monoclonal antibody administered on Day 7 then routinely.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PEF; Drug: Anti-PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success rate of PEF treatment
The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.
Measured: 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
Measured: 1 month
Secondary outcomes (5)
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%.
Measured: 3 months
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%.
Measured: 6 months
Progression free survival rate at 6 months
Measured: 6 months
Overall survival rate at 6 months
Measured: 6 months
Overall survival rate at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start6 Jul 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Energenx Medical LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiyue Li, MD, Principal investigator, The first Affiliated Hospital of Guanzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987345
- Sponsor's protocol ID
- LCFIM-001
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Efficacy Evaluation of Pulsed Electric Field Therapy in Patients With Late-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05987345
- Acronym / sponsor ID
- LCFIM-001
- Conditions
- NSCLC
- Keywords
- NSCLC, PEF, Immune Checkpoint Inhibitor(ICI)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Energenx Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients will will be enrolled to experimental arm and receive standard of care combining with PEF treatment on Day 1, followed by anti PD-1 on Day 7 and then routinely.
All kinds of adverse events will be recorded and analyzed to evaluate the safety of the treatment. At the same time, the local control rate of treated lesions, PFS and OS after PEF will be analyzed to evaluate the clinical value of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEF treatment | Experimental | Device: PEF, Drug: Anti-PD-1 monoclonal antibodyAll 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Eastern Cooperative Oncology Group(ECOG) performance status 0-1
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEFPEF device treated in the trial. | Device | PEF treatment |
| Anti-PD-1 monoclonal antibodyAnti-PD-1 monoclonal antibody administered on Day 7 then routinely. | Drug | PEF treatment |
Primary outcome
Technical success rate of PEF treatment
Time frame: 7 days
The percentage of the number that the equipment successfully reached the target lesion and completed PEF energy delivery.
Incidence of PEF treatment related AE/SAEs
Time frame: 1 month
The incidence and severity of PEF treatment related adverse events according to CTCAE version 4.0
5 secondary outcomes
Local control of ablated lesions by CT
Time frame: 3 months
Local control of ablated lesions by CT
Time frame: 6 months
Progression free survival rate at 6 months
Time frame: 6 months
Overall survival rate at 6 months
Time frame: 6 months
Overall survival rate at 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue Li, MD principal investigator
The first Affiliated Hospital of Guanzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEF and Anti-PD-1 monoclonal antibody in people with NSCLC, run by Energenx Medical LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Xu (+86 021 52230973, info@energenxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success rate of PEF treatment (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.