Microwave Ablation for Lung Cancer

No longer recruiting at 11 trial locations

Overseen By Erin Meyers, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ethicon, Inc.

Must not be taking: Antiplatelets, Warfarin, Anticoagulants

Disqualifiers: Pregnancy, Thoracic implants, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Immediate (day 0)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment method called transbronchial microwave ablation, a type of microwave ablation therapy, for individuals with certain lung tumors. It targets oligometastatic tumors, which are a few cancerous spots that have spread from another area, located in the outer part of the lung. The study employs advanced imaging to guide the procedure and assess its effectiveness 30 days post-treatment. It may suit individuals with a controlled primary cancer and a metastatic lung tumor not too close to the lung's edge. As an unphased trial, this study provides an opportunity to explore innovative treatment options for lung tumors.

Do I need to stop my current medications for the trial?

Yes, you may need to stop certain medications. Specifically, you must stop anti-platelet agents at least 5 days before the procedure and for 48-72 hours after. You must also stop warfarin 3-5 days before the procedure until your INR is less than 1.5, and for 48-72 hours after. Additionally, you must stop anticoagulants at least 3 days before the procedure and for 48-72 hours after. Other medications are not specified in the protocol.

What prior data suggests that this microwave ablation technique is safe for lung cancer treatment?

Research has shown that transbronchial microwave ablation, which uses heat to destroy tumors, is generally well-tolerated. In several studies, patients treated for lung tumors did not experience serious complications such as death or a collapsed lung, suggesting the procedure's safety.

For example, one study found that patients did not report severe issues after the procedure. Another study supported these findings, noting that the treatment is a practical option for lung cancer.

While these results are encouraging, individual responses can vary. Always discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transbronchial Microwave Ablation is unique because it offers a new way to target and destroy lung cancer cells directly inside the lungs. Unlike standard treatments like surgery or radiation, this method uses the NEUWAVE FLEX Microwave Ablation System to precisely heat and eliminate oligometastatic tumors. Researchers are excited about this treatment because it uses the Auris MONARCH Platform for better visualization and access, potentially leading to more effective and less invasive procedures. This approach could provide a promising alternative for patients with tumors in hard-to-reach areas of the lung.

What evidence suggests that transbronchial microwave ablation is effective for lung cancer?

Research has shown that transbronchial microwave ablation, the treatment under study in this trial, offers a promising approach for lung cancer. Studies have found it effectively treats lung tumors near the lung edges, particularly for patients unable to undergo surgery. One study reported no deaths or lung collapses (pneumothorax), highlighting its safety. The procedure uses a flexible tool and special imaging to accurately target and destroy cancer cells. Early results suggest it can help lung cancer patients by effectively shrinking tumors. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults (22+ years) with a few lung cancer spots, good performance status (able to carry out daily activities), and tumors in specific lung areas can join. They must not need continuous ventilator support, have severe lung damage, brain metastases, recent other lung treatments or be on certain blood thinners.

Inclusion Criteria

Willing to fulfill all follow-up visit requirements

My lung tumor is in the outer part of the lung and not near the lung surface.

I can take care of myself and am up and about more than 50% of my waking hours.

Exclusion Criteria

I haven't had any systemic therapy like chemotherapy in the last 14 days.

I cannot stop taking my blood thinning medication for 5 days before and up to 3 days after a procedure.

I haven't had lung surgery or treatment in the last 30 days and won't have any before a month after joining the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Transbronchial microwave ablation using the NEUWAVE FLEX Microwave Ablation System on oligometastatic tumors in the peripheral lung

Immediate (day 0)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary endpoint assessed 30 days post-ablation

30 days

1 visit (in-person)

Long-term Follow-up

Monitoring for local tumor progression, survival, and changes in pulmonary function and quality of life up to 12 months post-ablation

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Transbronchial Microwave Ablation

Trial Overview The study tests a new way to treat small areas of cancer in the lungs using microwave energy guided by advanced robotic technology and CT scans. The goal is to see how well it works one month after treatment.

How Is the Trial Designed?

Group I: Transbronchial Microwave Ablation Experimental Treatment 1 Intervention

Transbronchial microwave ablation will be performed using the NEUWAVE FLEX Microwave Ablation System and Accessories on oligometastatic tumors in the peripheral lung, guided by the Auris MONARCH Platform for visualization and access while using cone beam CT (computed tomography) to confirm probe tip placement and final ablation zone.

Transbronchial Microwave Ablation is already approved in United States for the following indications:

Approved in United States as NEUWAVE FLEX Microwave Ablation System for:

• Ablation (coagulation) of soft tissue in percutaneous, open surgical, and laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors

Who Is Running the Clinical Trial?

Ethicon, Inc.

Lead Sponsor

Trials

95

Recruited

62,300+

Tim Schmid

Ethicon, Inc.

Chief Executive Officer since 2023

Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom

Nancy Sabin

Ethicon, Inc.

Chief Medical Officer

MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University

Published Research Related to This Trial

A 63-year-old man with stage IIIC non-small cell lung cancer experienced significant immune-related adverse events (irAEs) after receiving neoadjuvant chemoimmunotherapy, including immunologic enterocolitis and interstitial lung disease, highlighting potential safety concerns in this treatment approach.

This case emphasizes the need for clinicians to be vigilant for signs of irAEs in patients undergoing neoadjuvant chemoimmunotherapy, as timely multidisciplinary management is crucial for addressing these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-organs perioperative immune-related adverse events and postoperative bronchial anastomotic fistula in a patient receiving neoadjuvant immunotherapy with NSCLC. Xu, Y., Lyu, X., Qin, Y., et al.[2022]

In a study of 9,712 patients with metastatic non-small cell lung cancer (NSCLC), those treated with immunotherapy experienced fewer adverse events (AEs) and incurred lower healthcare costs related to AEs compared to those receiving cytotoxic chemotherapy.

The incidence of AEs was lowest in the immunotherapy group, and while the costs associated with AEs were similar between immunotherapy and chemotherapy, immunotherapy patients were less likely to face high AE-related costs, suggesting a potential advantage in safety and economic burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Costs of Adverse Events in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer. Engel-Nitz, NM., Johnson, MP., Bunner, SH., et al.[2023]

In a study of 49 patients with stage IV lung adenocarcinoma, combining microwave ablation (MWA) with chemotherapy significantly improved progression-free survival (PFS) and time to local progression (TTLP) compared to chemotherapy alone.

The median PFS for patients receiving MWA with chemotherapy was notably better, indicating that MWA can be an effective adjunct treatment in managing advanced lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation combined with chemotherapy improved progression free survival of IV stage lung adenocarcinoma patients compared with chemotherapy alone. Li, C., Wang, J., Shao, JB., et al.[2020]

Transbronchial microwave ablation is an emerging treatment for lung nodules, but it can lead to complications such as pneumothorax and bronchopleural fistula, as seen in this case.

The implantation of an endobronchial valve was found to be a safe and effective solution for managing bronchopleural fistula following the procedure, leading to an immediate cessation of air leak.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of bronchopleural fistula with endobronchial valve in hybrid operating room following transbronchial microwave ablation. Mak, KL., Chan, JWY., Lau, RWH., et al.[2022]

The study demonstrated that bronchoscopic microwave ablation (MWA) using the NEUWAVE™ FLEX system and robotic-assisted bronchoscopy (RAB) with the MONARCH™ platform was performed safely in 17 Yorkshire swine, with no major complications or serious adverse events observed during the procedures.

Minor adverse events were noted, such as coughing in two animals and one requiring antibiotics for a suspected infection, but overall, the safety profile supports further clinical research into the efficacy of these devices for treating conditions like oligometastatic disease or primary non-small cell lung cancer (NSCLC).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy. De Leon, H., Royalty, K., Mingione, L., et al.[2023]

The study demonstrated that flexible bronchoscopy-guided water-cooled microwave ablation (MWA) is both feasible and safe for treating peripheral lung cancer in porcine models, with no complications reported during the procedures.

Ablation successfully created coagulation necrosis in lung tissue, indicating effective treatment, and showed signs of tissue repair after 4 weeks, suggesting potential for MWA as a therapeutic option for lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flexible bronchoscopy-guided microwave ablation in peripheral porcine lung: a new minimally-invasive ablation. Yuan, HB., Wang, XY., Sun, JY., et al.[2022]

In a pilot study involving 13 patients with inoperable peripheral lung cancer, endobronchial microwave ablation using navigation bronchoscopy achieved a technical success rate of 100%, indicating that the procedure is feasible and can be performed effectively.

The treatment resulted in a complete ablation rate of 78.6% and a 2-year local control rate of 71.4%, with a median progression-free survival of 33 months, suggesting that this method can provide significant therapeutic benefits for patients who are not candidates for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. Xie, F., Chen, J., Jiang, Y., et al.[2022]

Percutaneous microwave ablation (pMWA) is a safe and effective treatment for non-operable lung cancer, with a low incidence of serious adverse events reported during a clinical trial involving 6 patients and 7 lesions.

The procedure showed promising results in preserving pulmonary function, with minimal changes in lung capacity (FEV1 and DLCO) and significant reductions in tumor size and activity observed within 6 months post-ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective trial of CT-guided percutaneous microwave ablation for lung tumors. Reisenauer, JS., Eiken, PW., Callstrom, MR., et al.[2022]

Patients with EGFR-mutant lung cancer who are treated with epidermal growth factor receptor tyrosine kinase inhibitors (TKIs) may have an increased risk of developing pneumothorax when undergoing microwave ablation (MWA), as demonstrated in three case reports.

The cases highlight the importance of considering the potential for delayed pneumothorax or bronchopleural fistula in patients receiving TKIs prior to MWA, suggesting a need for careful patient selection and monitoring during these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pneumothorax triggered by EGFR-tyrosine kinase inhibitors in three microwave ablation candidates: A review of the literature. Guo, R., Li, Y., Bie, Z., et al.[2021]

In a pilot study involving 8 patients, endobronchial microwave ablation (MWA) successfully recanalized the airway in all cases without any complications, demonstrating its safety and efficacy for managing malignant central airway obstruction (CAO).

The technique effectively destroys tumors while preserving the airway structure, utilizing the 'oven effect' to safely devitalize tissue without harming surrounding areas, making it a promising option for patients with CAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microwave Ablation for Malignant Central Airway Obstruction: A Pilot Study. Senitko, M., Oberg, CL., Abraham, GE., et al.[2022]

In a study involving 98 patients with locally advanced non-small cell lung cancer (NSCLC), targeted percutaneous microwave ablation combined with mediastinal radiotherapy significantly reduced the incidence of radiation pneumonia (RP) compared to traditional radiotherapy, with 3.9% of patients in the ablation group experiencing RP versus 31.9% in the radiotherapy group (P < 0.001).

Although the 2-year overall survival rates were higher in the ablation group compared to the radiotherapy group, the difference was not statistically significant (P = 0.297), suggesting that while ablation may improve local control and reduce adverse effects, it does not yet show a clear survival advantage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted percutaneous microwave ablation at the pulmonary lesion combined with mediastinal radiotherapy with or without concurrent chemotherapy in locally advanced non-small cell lung cancer evaluation in a randomized comparison study. Xu, X., Ye, X., Liu, G., et al.[2018]

Neoadjuvant immunotherapy using immune checkpoint inhibitors like PD-1 and PD-L1 antibodies shows promise in improving treatment outcomes for patients with resectable stage IIIA non-small cell lung cancer (NSCLC), potentially increasing the rate of complete tumor resection and major pathological remission.

However, the use of neoadjuvant immunotherapy can lead to serious adverse reactions that may complicate surgery, highlighting the need for careful management and clinical guidelines to address these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical recommendations for perioperative immunotherapy-induced adverse events in patients with non-small cell lung cancer. Ni, J., Huang, M., Zhang, L., et al.[2022]

The use of a novel three-dimensional visualization ablation planning system (3D-VAPS) in microwave ablation (MWA) for stage I non-small cell lung cancer (NSCLC) resulted in a 100% technical success rate and a 97.35% complete ablation rate three months post-procedure, indicating high efficacy.

The study reported no deaths during or within 30 days after the MWA procedure, and while complications such as pneumothorax and intrapulmonary hemorrhage occurred, the overall safety profile was deemed acceptable, suggesting that 3D-VAPS can help optimize the procedure and reduce risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and feasibility of three-dimensional visualization planning system for CT-guided microwave ablation of stage I NSCLC (diameter ≤2.5 cm): A pilot study. Hu, Y., Xue, G., Liang, X., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03603652

NEUWAVE Flex Microwave Ablation System in the ... Patients with medically inoperable primary soft tissue lesion of the lung will have transbronchial microwave ablation performed via transbronchial approach ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10064382/

Novel Image-Guided Flexible-Probe Transbronchial ... This study aimed to determine if image-guided transbronchial microwave ablation (tMWA) is a feasible approach to treat peripheral stage 1 lung cancer.

3. jnjmedtech.com jnjmedtech.com/en-US/news-events/first-patient-treated-north-america-robot-assisted-transbronchial-microwave-ablation

Robot-Assisted Transbronchial Microwave Ablation | Ethicon This prospective, multicenter, single-arm study is intended to demonstrate the safety and effectiveness of transbronchial microwave ablation.

4. mayo.edu mayo.edu/research/clinical-trials/tests-procedures/microwave-ablation-for-cancer

Microwave Ablation For Cancer Clinical Trials The purpose of this study is to evaluate if lung ablation improves clinical outcomes for patients deemed to be surgically high-risk. ... lung will have ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10984635/

Transbronchial Microwave Ablation of Peripheral Lung ... Transbronchial microwave ablation is an alternative treatment modality for malignant lung nodules ≤30 mm. There were no deaths or pneumothorax.

6. bmcsurg.biomedcentral.com bmcsurg.biomedcentral.com/articles/10.1186/s12893-025-03230-y

Safety and feasibility of bronchoscopic microwave ablation ... Our study aims to evaluate the safety and feasibility of transbronchial microwave ablation for lung cancer using state of the art bronchoscopy ...

7. journals.lww.com journals.lww.com/bronchology/fulltext/2024/04000/transbronchial_microwave_ablation_of_peripheral.9.aspx

Transbronchial Microwave Ablation of Peripheral Lung... Transbronchial microwave ablation is an alternative treatment modality for malignant lung nodules ≤30 mm. There were no deaths or pneumothorax.

8. tlcr.amegroups.org tlcr.amegroups.org/article/view/51418/html

Transbronchial microwave ablation of lung nodules with ... Percutaneous microwave ablation for lung tumours produced reasonable results, with cancer-specific survivals ranging between 69–84.3% at 1 year, 42.1–61% at ...