Percutaneous Pulsed Electric Field Ablation for Early-Stage NSCLC and Lung Oligometastases: A Safety and Efficacy Study

NCT07799194 | Not Yet Recruiting

• 1 other identifier: LC-102
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Lung Cancer (NSCLC)

Keywords

Lung Caner(NSCLC); Pulsed Electric Field Ablation

Outcome Measures

Primary Outcomes (1)

• 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

  Through 12 months

Secondary Outcomes (5)

• The success rate of the ablation procedure

  Once the procedure is completed.

• The technical success rate of the PEF ablation

  At 24-hour post the procedure

• Complete ablation rate of the target lesions at 6-month and 12-month post the ablation.

  At 6-month and 12-month

• Proportion of patients with target tumor progression free survival (PFS) at 6-month and 12-month.

  At 12 months

• Overall Survival (OS) through 12 months.

  At 12 months

Other Outcomes (3)

• Proportion of patients requiring initiation of any other anti-tumor interventions since PEF ablation up to 12 months.

  At 12-month

• Pulmonary function measures at 6-month and 12-month

  Through 12 months

• Quality of Life assessed at 3-month, 6-month and 12-month.

  through 12 months

Study Arms (1)

Single arm

OTHER

A non-thermal energy named pulsed electric field(PEF)

Device: Pulsed Electric Field Ablation

Interventions

Pulsed Electric Field Ablation DEVICE

Application of Pulsed Electric Field energy to ablate the lung tumor through percutaneous approach.

Single arm

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Energenx Medical LTD.: lead

Study Sites (1)

The First Affiliated Hospital of Guagnzhou Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Central Study Contacts

Shaoyu Yang, Doctor

CONTACT

+86-18910093103; Shaoyu.yang@energenxmedical.com

Xiao Xu, Head of Administrator

CONTACT

Sara.Xu@energenxmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

CN (1)