NSCLCNCT06739031
Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field Ablation Devices in the Treatment of Lung Tumors
A study testing PEF Treatment 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 efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are: Safety of PEF treatment of early-stage unreseectable NSCLC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- PEF Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 25 Aug 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria (all requirements must be met at the same time):
- Age ≥ 18 years old; 2. Pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ECOG score ≤ 2 points; 5. According to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. The subject agrees to receive ablation treatment and signs the informed consent form.
Exclusion criteria (if any of the above conditions are met, the patient will be excluded):
- The subject cannot tolerate or refuses general anesthesia;
- Has a history of severe allergic reactions;
- Has contraindications to bronchoscopy or refuses bronchoscopy;
- Has active implants in the chest cavity or metal implants in the lung to be treated; 6. Uncorrectable coagulation abnormalities (INR>1.5 or APTT>1.5 ULN), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets <50×10^9/L; 7. Severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. Accompanied by infectious diseases that cannot be effectively controlled; 9. Subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. Acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. Subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of II degree type II or III degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. Subjects have participated in or are participating in other clinical trials within three months; 13. Pregnant, lactating women, or women who plan to become pregnant during the study; 14. Subjects determined by the researchers to have other conditions that are unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine,
Shanghai
Jiayuan Sun, M.D., PhD., jysun1976@163.com
About this study
Official title: A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors
The goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.
The main questions it aims to answer are:
- Safety of PEF treatment of early-stage unreseectable NSCLC patients.
- Locoregional control of ablated lesions.
- Survival and quality of life assessment of early-stage unreseectable NSCLC patients.
- Conditions
- NSCLC
- Being tested
- PEF Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEF TreatmentDevice
PEF Energy ablation of lung tumors
| Study group | Role | What they receive |
|---|---|---|
| PEF Treatment | Experimental | Not described Receives: Device: PEF Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month complete ablation rate
Measured: 6 months
Secondary outcomes (5)
Technical success rate
Measured: immediately after the PEF ablation treatment
6-month pulmonary progression-free survival rate
Measured: 6 months after the first PEF ablation treatment
12-month complete ablation rate
Measured: 12 months after the first PEF ablation treatment
12-month pulmonary progression-free survival rate
The proportion of subjects with no pulmonary progression (the first ablation lesion maintained no progression, no hilar lymph node metastasis, no new lesions) accounted for the proportion of evaluable subjects who received ablation
Measured: 12 months after the first PEF ablation treatment
12-month overall survival rate
Measured: 12 months after the first PEF ablation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start25 Dec 2024
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Aug 2027 (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
- 126 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
- NCT06739031
- Sponsor's protocol ID
- LC-101
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2024
- Last updated
- 21 Aug 2026
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Single-group Clinical Trial to Evaluate the Efficacy and Safety of Pulsed Electric Field (PEF) Ablation Devices in the Treatment of Lung Tumors
- ClinicalTrials.gov ID
- NCT06739031
- Acronym / sponsor ID
- LC-101
- Conditions
- NSCLC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Energenx Medical LTD.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2024 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 18 Dec 2024 (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 efficacy and safety of pulsed electric field (PEF) treatment of early-stage unreseectable non-small cell lung cancer(NSCLC) patients.
The main questions it aims to answer are:
- Safety of PEF treatment of early-stage unreseectable NSCLC patients.
- Locoregional control of ablated lesions.
- Survival and quality of life assessment of early-stage unreseectable NSCLC patients.
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 Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PEF TreatmentPEF Energy ablation of lung tumors | Device | PEF Treatment |
Primary outcome
6-month complete ablation rate
Time frame: 6 months
5 secondary outcomes
Technical success rate
Time frame: immediately after the PEF ablation treatment
6-month pulmonary progression-free survival rate
Time frame: 6 months after the first PEF ablation treatment
12-month complete ablation rate
Time frame: 12 months after the first PEF ablation treatment
12-month pulmonary progression-free survival rate
Time frame: 12 months after the first PEF ablation treatment
12-month overall survival rate
Time frame: 12 months after the first PEF ablation treatment
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 21 Aug 2026.
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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.
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 Treatment 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?
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: looking for participants now, as of the sponsor's last update on 21 Aug 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 Sara Xu (021, sara.xu@energenxmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month complete ablation rate (time frame: 6 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 21 Aug 2026.