Microwave Ablation in Chinese Patients With Lung Tumors

NCT04889989 | Terminated Results FDA Device

• 1 other identifier: NEU_2020_02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 8

Brief Summary

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors will all receive microwave ablation (MWA) performed percutaneously by doctors who are experienced in lung tumor ablation. 120 patients will participate across 8 clinical study sites all in China.

Conditions

Cancer of the Lung

Outcome Measures

Primary Outcomes (1)

• Technical Efficacy Rate

  Percentage of tumors that were completely covered by the ablation zone with no sign of pathological enhancement according to the lung contrast-enhanced CT assessment as assessed by the Independent Review Committee.

  30 days (+/- 7 days) post-ablation

Secondary Outcomes (4)

• Technical Success Rate

  Ablation Day (day 0)

• Local Tumor Progression

  1 year post-ablation

• Overall Survival

  1-year post-ablation

• Progression-Free Survival

  1-year post-ablation

Study Arms (1)

Microwave Ablation of Lung Tumor

OTHER

Adult patients with non-small cell lung cancer (NSCLC) or oligometastatic lung tumors who plan to receive percutaneous microwave ablation.

Device: Microwave Ablation

Interventions

Microwave Ablation DEVICE

Percutaneous microwave ablation using the NeuWave Microwave Ablation System for non-small cell lung cancer or oligometastatic lung tumors

Microwave Ablation of Lung Tumor

Eligibility Criteria

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

You may qualify if:

• Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule.
• Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy.
• ECOG performance status score of 0-2.
• Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor.
• Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or a maximum of three ipsilateral oligometastatic lung tumors.
• Tumor(s) to be ablated in a single surgery should be ≤ 2cm, locate in the outer two-thirds of a lung, not closer than 1 cm from the hilum of lung, great vessels, principal bronchus, trachea or esophagus, and not contiguous with the pleura.

You may not qualify if:

• Pregnant or breast-feeding.
• Patients with implantable pacemakers or other electronic implants.
• Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist.
• Any planned concurrent procedure at the time of ablation.
• Planned treatment for other tumors in the same side lung during the study period.
• With a skin infection or ulceration at the site to be punctured by probe(s).
• Clinical or imaging findings consistent with an active pulmonary infection.
• Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis.
• Patients with prior radiotherapy in the area intended to ablate.
• Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
• Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease.
• The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones.
• Patients who have received lung ablation or surgical resection therapy within 30 days prior to the ablation procedure under study and those who plan to receive lung tumor ablation or surgical resection therapy or radiation therapy on the ablated lung side before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
• Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or immunotherapy within 7 days prior to the ablation procedure under study, and patients who had a systemic treatment plan such as chemotherapy, targeted drug therapy, immunotherapy, etc. before completing the primary efficacy endpoint assessment approximately 30 days after the ablation procedure.
• Patients with uncorrectable coagulopathy based on investigator judgment.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (8)

Beijing Hospital

Beijing, China

Location

Pecking University Shenzhen Hospital

Beijing, China

Location

The First Affiliated Hospital of Fujian Medical University

Fujian, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Location

Henan Cancer Hospital

Henan, China

Location

Hunan Cancer Hospital

Hunan, China

Location

Qilu Hospital of Shandong University

Shandong, China

Location

Fudan University Shanghai Cancer Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The study was originally statistically powered and planned to enroll/treat 120 patients. However, the study was terminated early after a change in Sponsor strategy. Only 13 patients (4 being run-in) across 2 sites were enrolled and treated. All results provided are descriptive in nature only.

Results Point of Contact

• Title: Erin Meyers
• Organization: Ethicon, Inc.

eprifog1@its.jnj.com

937-681-0322

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Model Details: Single-arm, prospective, multicenter clinical trial with a performance goal

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: December 27, 2021
• Primary Completion: October 22, 2022
• Study Completion: September 14, 2023
• Last Updated: February 4, 2026
• Results First Posted: October 15, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (8)