An interventional study of Pulsed Electric Field Ablation in Lung Cancer (NSCLC), sponsored by Energenx Medical LTD.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Energenx Medical LTD. · Not applicable, Interventional, and Treatment
The goal of this observational study is to evaluate the performances of a percutaneous Pulsed Electrical Field (PEF) ablation to treat patients with primary early-stage lung cancer (NSCLC) or lung oligometastatic Tumors who are unresectable or refusal surgery/Radiotherapy.
The main questions the study aims to answer are:
The safety and technical feasibility of the PEF ablation. The preliminary efficacy of the PEF ablation for target lesion in lung
Patients who meet the inclusion/exclusion criteria will be given percutaneous PEF ablation to the target lesions under general anesthesia. Then follow-up to 12 months to monitor any progression by about 3 months interval.
Target Subject： Patients with early-stage primary non-small cell lung cancer(NSCLC) or pulmonary oligometastatic tumors who are not surgical resectable or unsuitable for surgery/radiotherapy
Safety, technical feasibility including procedure operation success and tumor ablation technical success be evaluated.
The primary efficacy endpoint is the complete ablation rate of the ablated lesions at month 6.
Other efficacy endpoints are local tumor progression-Free Survival(PFS), Overall Survival (OS) and proportion of patients requiring initiation of other anti-tumor interventions through 12 months. Pulmonary function and quality of life (EORTC QLQ-C30, EORTC QLQ-LC13) will be assessed as well.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Energenx Medical LTD. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lung Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Currently receiving systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy etc.
(For pulmonary oligometastatic tumors with primary cancer controlled already, if systemic anti-tumor therapy still needs to be continued, it is acceptable. For primary NSCLC patients, according to guideline recommendations, no concurrent systemic anti-tumor therapy is indicated).
Implanted electronic device in the body (such as pacemaker, implantable cardioverter defibrillator, or neurostimulator).
(it is acceptable If the implanted electronic device is allowed to be turned off during the procedure)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A non-thermal energy named pulsed electric field(PEF)
Device: Pulsed Electric Field Ablation
Application of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.
The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.
Adverse events rate and severe adverse event rate related to the device and/or procedure during the ablation procedure and thereafter 12 months follow-Up
Time frame: Through 12 months
The success rate of the ablation procedure
The success rate of the procedure is defined as the proportion of ablation procedures in which the PEF treatment catheter is deployed to the target lesion and pulsed electrical field energy is delivered and then the catheter is withdrawn out from lung
Time frame: Once the procedure is completed.
The technical success rate of the PEF ablation
The technical success rate of the PEF ablation that is defined as the proportion of lesions where the CT imaging-assessed ablation zone (Post-ablation Target Zone, PTZ) is larger than the gross tumor region (GTR) at least 5 mm.
Time frame: At 24-hour post the procedure
Complete ablation rate of the target lesions at 6-month and 12-month post the ablation.
Complete ablation of the target lesions is defined as to achieve the following criteria on contrast-enhanced CT images ① Lesion disappears; ② Complete cavity formation; ③ Lesion fibrosis, which may be a scar; ④ Lesion shrinks, remains unchanged, or enlarges, but shows no enhancement on contrast-enhanced CT and/or no metabolic activity on PET/CT; ⑤ Atelectasis, with the lesion within the atelectasis showing no contrast enhancement on CT and/or no metabolic activity on PET/CT. The baseline is defined as CT image of 4-6 weeks post the ablation.
Time frame: At 6-month and 12-month
Proportion of patients with target tumor progression free survival (PFS) at 6-month and 12-month.
The proportion of subjects without target lesion progression in lung at 6-month and 12-month post the PEF procedure in evaluative subjects.
Time frame: At 12 months
Overall Survival (OS) through 12 months.
The proportion of surviving subjects at 12 months after completion of PEF ablation therapy in those evaluative subjects.
Time frame: At 12 months
Proportion of patients requiring initiation of any other anti-tumor interventions since PEF ablation up to 12 months.
Time frame: At 12-month
Pulmonary function measures at 6-month and 12-month
The pulmonary function measures includes Forced Vital Capacity (FVC) in liter, Forced Expiratory Volume in the first second (FEV1) in liter, Ratio of FEV1/FVC in percentage, Total Lung Capacity (TLC) in liter, Residual Volume (RV) in liter, Ratio of RV/TLC in percentage and Diffusing Capacity of the Lungs for Carbon Monoxide(DLCO) in ml/mmHg/min and the percentages of all of the measures compared with the predicted value accordingly at 6-month and 12-month post procedure.
Time frame: Through 12 months
Quality of Life assessed at 3-month, 6-month and 12-month.
EORTC QLQ-C30(European Organisation for Research and Treatment of Cancer Quality of Life, The Core Questionnaire) and EORTC QLQ-LC13 (European Organisation for Research and Treatment of Cancer Quality of Life, Lung Cancer Questionnaire) be used to assess the quality of life. EORTC QLQ-C30(version 3.0) include global health status, functional scale and symptom scales/items. The range of the score is from zero to 100 points. For functional and global health status, the higher score mean a better conditions. For symptom domain, the higher score reversely indicates worse status. EORTC QLQ-LC13 is designed to assess the quality of life in patient with lung cancer. The range of score is from zero to 100 points. The higher score mean the worse symptoms.
Time frame: through 12 months
Plan to share: Undecided — so far it has not be decided.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2027, 15 months later.
Of 359 interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 97. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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