Can a needle through the windpipe beat the knife for early lung cancer?
NCT ID NCT07741344
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether a minimally invasive procedure called bronchoscopic microwave ablation can be as effective as surgery for early-stage lung cancer (stage IA). The procedure uses a bronchoscope to guide a needle to the tumor and destroy it with heat, potentially preserving more lung tissue. The study will compare disease-free survival, lung function, and quality of life between the two approaches in about 292 adults.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bronchoscopic microwave ablation
- What this could lead to
- If successful, this could establish a less invasive, lung-sparing option for early-stage lung cancer, potentially reducing recovery time and preserving lung function.
- What could go wrong
- The trial is in Phase 2, and the ablation may not control the cancer as well as surgery. There are risks of incomplete ablation or complications from the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 292 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Bronchoscopic Microwave Ablation Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. Determined by multidisciplinary evaluation to be an appropriate candidate for bronchoscopic ablation as part of standard clinical care, and the patient agrees to a lung-preserving treatment approach 4. Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT 5. Tumour located in the middle or peripheral third of the lung parenchyma 6. Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required 7. Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols 8. Pulmonary function results or clinical assessment indicate significant benefit from preserving lung tissue, such as predicted FEV1 or DLCO less than 40%, or clinician judgment that lung preservation is critical for quality of life 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria 1. Presence of lymph node involvement (N1 or higher) or distant metastases (M1) 2. Centrally located tumours within the inner third of the lung or those requiring ablation near major airways 3. Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved 4. Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation 5. Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging 6. Pregnant or breastfeeding women 7. Inability or unwillingness to comply with study procedures 8. Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy 9. Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4 10. Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study Surgical Resection Group Inclusion Criteria 1. Adults aged ≥18 years 2. Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm) 3. Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection. 4. Tumour size between 2.5 and 3.0 cm, or smaller lesions for which surgery is considered the more appropriate option based on tumour features or safety concerns. 5. Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins. 6. Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging. 7. Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging. 8. Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment Exclusion Criteria 1. Presence of lymph node involvement (N1 or higher) or distant metastases (M1) 2. High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred. 3. Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins). 4. Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection. 5. Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study. 6. Pregnant or breastfeeding women 7. Inability or unwillingness to comply with study procedures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Prince of Wales Hospital
Hong Kong, Hong Kong