Lung Cancer (NSCLC)NCT07799194
Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study
A study testing Pulsed Electric Field Ablation in people with Lung Cancer (NSCLC), run by Energenx Medical LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Pulsed Electric Field Ablation
- 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
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years but ≤ 79 years, male or female
- Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
- For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides <5), the maximum diameter of the lesion(s) is ≤3cm.
- ECOG score ≤ 2;
- Expected survival ≥ 12 months;
- Clinical assessment as unsuitable for surgical resection or refusing surgery and radiotherapy.
- Assessed by an anesthesiologist as suitable for general anesthesia;
- Agree to receive ablation therapy and sign the informed consent form.
Who cannot join
- Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.
- 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).
- The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
- With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
- Anemia (Hemoglobin (HGB) < 9 g/dL), dehydration, and severe metabolic disorders that cannot be improved or well managed in the short term.
Show all 22Show fewer
- Coagulation abnormalities (INR >1.5 or APTT >1.5 ULN), or platelet count below 90 x 10^9/L.
- Uncontrolled lung or systemic infection. Or uncontrolled skin infection at the puncture site or fever > 38.5°C.
- Currently using anticoagulant therapy and/or antiplatelet drugs (such as warfarin, dabigatran, rivaroxaban, and other new oral anticoagulants) and have not been discontinued for more than 5 to 7 days prior to ablation therapy.
- Receiving high-dose immunosuppressive drugs (prednisone exceeding 10mg/day or equivalent). If discontinued for more than 4 weeks, it is acceptable.
- Subject has comorbidity of severe other lung diseases (including interstitial pneumonia, pulmonary fibrosis, severe emphysema or atelectasis) and unsuitable for enrollment with the judgement of the investigator.
- Malignant pleural effusion on the treatment side of lung.
- Severe uncontrolled hypertension, diabetes, severe abnormal liver or kidney function, or heart failure that investigator assessed as unsuitable for enrollment.
- Acute cardio-cerebrovascular events within 3 months, such as acute hemorrhagic or ischemic stroke, acute coronary syndrome, acute myocardial infarction.
- Psychiatric disease that not well controlled.
- With a history of recurrent tachyarrhythmia past 2 years. (Including rapid atrial arrhythmias, any rapid ventricular arrhythmias); or history of type II second-degree or III degree atrioventricular block or sinus bradycardia with heart rate < 45 beats/min, or sinus tachycardia > 120 beats/min.
- 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)
- There is metal implants near the lesion to be ablated lesion (distance < 2-3cm) in the lung.
- Patient is currently participating in another clinical trial.
- Pregnant or breastfeeding women, or women planning to become pregnant during the study period.
- Other situations judged by investigator as unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiao Xu, Head of Administrator contact
China1 site
The First Affiliated Hospital of Guagnzhou Medical University
Guangzhou, Guangdong
Chengzhi Zhou, Professor, doctorzcz@163.com
Xiaohong Xie, Associated Director, gyxxh@126.com
About this study
Official title: A Clinical Study To Evaluate Safety, Technical Feasibility, and Preliminary Efficacy of A Pulsed Electrical Field Ablation Through Percutaneous Approach For Treatment of Patient With Primary Early-Stage Non-Small Cell Lung Cancer or Lung Oligo-metastatic Tumor Who Are Unresectable or Refusal to Surgery/Radiotherapy.
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:
Read more
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
Read the detailed description
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.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Pulsed Electric Field Ablation
- Keywords
- Lung Caner(NSCLC), Pulsed Electric Field Ablation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electric Field AblationDevice
Application of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | A non-thermal energy named pulsed electric field(PEF) Receives: Device: Pulsed Electric Field Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through 12 months
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799194
- Sponsor's protocol ID
- LC-102
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: so far it has not be decided.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study To Evaluate Safety, Technical Feasibility, and Preliminary Efficacy of A Pulsed Electrical Field Ablation Through Percutaneous Approach For Treatment of Patient With Primary Early-Stage Non-Small Cell Lung Cancer or Lung Oligo-metastatic Tumor Who Are Unresectable or Refusal to Surgery/Radiotherapy.
- ClinicalTrials.gov ID
- NCT07799194
- Acronym / sponsor ID
- LC-102
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Lung Caner(NSCLC), Pulsed Electric Field Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Energenx Medical LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 2 Sep 2026 (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 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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Pulsed Electric Field AblationA non-thermal energy named pulsed electric field(PEF) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years but ≤ 79 years, male or female
- Pathologically diagnosed primary NSCLC and stage IA, or oligometastatic lung tumors that primary cancer has been controlled. the maximum diameter of the lesion is ≤3cm, (Pathological diagnosis includes conventional pathological examination or ROSE rapid on-site evaluation)
- For multiple primary lung cancers, the number of lesions is ≤3 and the maximum diameter of the lesion(s) is ≤3cm. For metastatic tumors, the number of lesions in one side of lung is ≤3 (total lesions in both sides <5), the maximum diameter of the lesion(s) is ≤3cm.
- ECOG score ≤ 2;
- Expected survival ≥ 12 months;
Key exclusion criteria (22 listed)
- Received any form of local tumor therapy for the target lung tumor lesion(s) within 6 months.
- 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).
- The distance between tumor lesion edge and important structures such as heart, diaphragm and mediastinum is less than 10mm.
- With a history of hypersensitivity to medications to be used in general anesthesia or drugs required during the procedure/follow-up (such as contrast-enhanced CT scan).
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 |
|---|---|---|
| Pulsed Electric Field AblationApplication of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach. | Device | Single arm |
Primary outcome
The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up.
Time frame: Through 12 months
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
5 secondary outcomes
The success rate of the ablation procedure
Time frame: Once the procedure is completed.
The technical success rate of the PEF ablation
Time frame: At 24-hour post the procedure
Complete ablation rate of the target lesions at 6-month and 12-month 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.
Time frame: At 12 months
Overall Survival (OS) through 12 months.
Time frame: At 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided. so far it has not be decided.
Related trials for Lung Cancer (NSCLC)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Xiao Xu, Head of Administrator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electric Field Ablation in people with Lung Cancer (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 22 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaoyu Yang, Doctor (+86-18910093103, Shaoyu.yang@energenxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical safety of the device and/or procedure in the operation of PEF ablation and entire study follow-up. (time frame: Through 12 months). 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 10 Sep 2026.