Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC

Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited.

Objective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC.

Methods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT.

Surveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation.

Impact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.