Cancer of the Lung
Conditions
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.
Interventions
DEVICEMicrowave Ablation
Percutaneous microwave ablation using the NeuWave Microwave Ablation System for non-small cell lung cancer or oligometastatic lung tumors
Sponsors
Ethicon, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm, prospective, multicenter clinical trial with a performance goal
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed the informed consent form and willing to fulfill the study-related assessments and procedure schedule. 2. Lung tumor patients ≥ 18 years of age who are ineligible for/decline surgery and who plan to receive microwave ablation therapy. 3. ECOG performance status score of 0-2. 4. Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients with clinically diagnosed oligometastatic lung tumor. 5. 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. 6. 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.
Exclusion criteria
1. Pregnant or breast-feeding. 2. Patients with implantable pacemakers or other electronic implants. 3. Oligometastatic tumors patients whose primary lesion cannot be controlled or have widely metastases, in the opinion of the investigator and/or treating oncologist. 4. Any planned concurrent procedure at the time of ablation. 5. Planned treatment for other tumors in the same side lung during the study period. 6. With a skin infection or ulceration at the site to be punctured by probe(s). 7. Clinical or imaging findings consistent with an active pulmonary infection. 8. Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-induced pulmonary fibrosis. 9. Patients with prior radiotherapy in the area intended to ablate. 10. Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate. 11. Tumors where the anticipated zone of ablation would encompass significant (in the opinion of the treating physician) emphysematous or bullous disease. 12. The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated may have overlapping ablation zones. 13. 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. 14. 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. 15. Patients with uncorrectable coagulopathy based on investigator judgment. 16. Patients with a platelet count ≤ 50 × 109/L. 17. Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours post-procedure. 18. Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours post-procedure. 19. Patients who cannot discontinue warfarin before at least 5 days before the ablation procedure of the study or have an INR \> 1.5. 20. As judged by the investigator, the patient has hypertension that cannot be effectively controlled by pharmacological treatments. 21. Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia, dehydration, and severe nutrition and metabolism disorders, which cannot be corrected or improved within a short term; or serious systemic infection; or severe neuromuscular diseases. 22. Expected survival less than 6 months. 23. Participation in any other interventional clinical study within 30 days before screening. 24. Physical or psychological condition which would impair study participation. 25. Patient is judged unsuitable for study participation by the investigator for any other reason. Intra-Ablation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Efficacy Rate | 30 days (+/- 7 days) post-ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Tumor Progression | 1 year post-ablation | Progression of disease to a tumor treated during the original microwave ablation procedure. |
| Overall Survival | 1-year post-ablation | Rate of patients still alive 1-year post-ablation (includes lead-in participants so out of 13). |
| Technical Success Rate | Ablation Day (day 0) | Percentage of tumors that achieve A0 or A1 ablation classification determinations (i.e., complete tumor ablation with a surrounding margin) based on the lung CT immediately following the initial ablation procedure and as assessed by the Independent Review Committee. |
| Progression-Free Survival | 1-year post-ablation | Rate of patients still alive 1-year post-ablation without any sort of progression of disease (local, regional, or distant). |
Countries
China
Participant flow
Recruitment details
Chinese adult patients with NSCLC (non-small cell lung cancer) or oligometastatic lung tumors (2cm or less in size) who were candidates for percutaneous microwave ablation were considered for the study. Patients were given the Informed Consent Form to read, ask questions, and sign prior to any study procedures being performed or data being collected.
Pre-assignment details
As a single-arm study, all patients enrolled received the same treatment: microwave ablation using the NEUWAVE Microwave Ablation System and Probes. The first 2 patients at each treating site (2 patients at 2 sites = 4 total patients) were part of the 'run-in' cohort. The Run-In cohort was implemented to reduce operational bias due to the learning curve. Run-In patients were included in the safety analysis set only.
Participants by arm
| Arm | Count |
|---|---|
| Microwave Ablation Lung tumors treated with microwave ablation (includes the run-in patients) and still alive at the end of the study (1-year post-ablation) | 9 |
| Microwave Ablation Lung tumors treated with microwave ablation (includes the run-in patients) and still alive at the end of the study (1-year post-ablation) | 10 |
| Total | 19 |
Baseline characteristics
| Characteristic | Microwave Ablation |
|---|---|
| Age, Continuous | 54.0 Years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 13 |
| other Total, other adverse events | 10 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
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.
Time frame: 30 days (+/- 7 days) post-ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Microwave Ablation | Technical Efficacy Rate | 8 Tumors |
Secondary
Local Tumor Progression
Progression of disease to a tumor treated during the original microwave ablation procedure.
Time frame: 1 year post-ablation
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Microwave Ablation | Local Tumor Progression | 1 Tumors |
Secondary
Overall Survival
Rate of patients still alive 1-year post-ablation (includes lead-in participants so out of 13).
Time frame: 1-year post-ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microwave Ablation | Overall Survival | 12 Participants |
Secondary
Progression-Free Survival
Rate of patients still alive 1-year post-ablation without any sort of progression of disease (local, regional, or distant).
Time frame: 1-year post-ablation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Microwave Ablation | Progression-Free Survival | 10 Participants |
Secondary
Technical Success Rate
Percentage of tumors that achieve A0 or A1 ablation classification determinations (i.e., complete tumor ablation with a surrounding margin) based on the lung CT immediately following the initial ablation procedure and as assessed by the Independent Review Committee.
Time frame: Ablation Day (day 0)
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Microwave Ablation | Technical Success Rate | 9 Tumors |