Microwave Ablation for Lung Cancer

Recruiting at 10 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)

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new procedure that uses microwave energy to destroy lung tumors. It targets patients with a few metastatic lung tumors. The treatment involves a device that heats and kills cancer cells, guided by robotic and imaging technology for accuracy. This developing treatment option offers advantages such as larger treatment areas and shorter heating times compared to other methods.

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 data supports the idea that Microwave Ablation for Lung Cancer is an effective treatment?

The available research shows that Microwave Ablation (MWA) for lung cancer can be effective, especially when combined with chemotherapy. One study found that patients with stage IV lung adenocarcinoma who received MWA along with chemotherapy had better outcomes compared to those who only received chemotherapy. This suggests that MWA can help improve the time patients live without the cancer getting worse. Additionally, MWA is being explored as a safe and feasible option for patients who cannot undergo surgery, offering a local treatment for inoperable lung cancer. ^{1 2 3 4 5}

What safety data is available for microwave ablation in lung cancer treatment?

The safety data for microwave ablation in lung cancer treatment includes a study comparing targeted percutaneous microwave ablation combined with mediastinal radiotherapy to radiotherapy alone in patients with locally advanced non-small cell lung cancer (NSCLC). The study found a significantly lower incidence of radiation pneumonia in the ablation group (3.9%) compared to the radiotherapy group (31.9%). Additionally, there are reports of pneumothorax occurring in patients who were candidates for microwave ablation and treated with EGFR-tyrosine kinase inhibitors, suggesting a potential risk of pneumothorax or bronchopleural fistula in these patients. Overall, while microwave ablation appears to have a lower risk of certain adverse effects like radiation pneumonia, there are other risks such as pneumothorax that need to be considered. ^{6 7 8 9 10}

Is Transbronchial Microwave Ablation a promising treatment for lung cancer?

Yes, Transbronchial Microwave Ablation is a promising treatment for lung cancer. It offers a new way to treat lung cancer that can't be removed by surgery. Studies show it can be safe and effective, and it can even help improve survival when combined with chemotherapy. ^{1 5 11 12 13}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Management of bronchopleural fistula with endobronchial valve in hybrid operating room following transbronchial microwave ablation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy. [2023]

4. China pubmed.ncbi.nlm.nih.gov

Flexible bronchoscopy-guided microwave ablation in peripheral porcine lung: a new minimally-invasive ablation. [2022]

5. Singapore pubmed.ncbi.nlm.nih.gov

Microwave ablation combined with chemotherapy improved progression free survival of IV stage lung adenocarcinoma patients compared with chemotherapy alone. [2020]

6. United States 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. [2018]

7. Singapore 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. [2022]

8. Singapore pubmed.ncbi.nlm.nih.gov

Pneumothorax triggered by EGFR-tyrosine kinase inhibitors in three microwave ablation candidates: A review of the literature. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Real-World Costs of Adverse Events in First-Line Treatment of Metastatic Non-Small Cell Lung Cancer. [2023]

10. Singapore pubmed.ncbi.nlm.nih.gov

Clinical recommendations for perioperative immunotherapy-induced adverse events in patients with non-small cell lung cancer. [2022]

11. China pubmed.ncbi.nlm.nih.gov

A prospective trial of CT-guided percutaneous microwave ablation for lung tumors. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Microwave Ablation for Malignant Central Airway Obstruction: A Pilot Study. [2022]

13. India 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. [2023]