Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC

NCT07722182 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: 2026.364
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer (NSCLC)

Keywords

Non-small cell lung cancer; navigation bronchoscopy; robotic assisted bronchoscopy; microwave ablation; stereotactic body radiotherapy; pragmatic randomised trial; local tumour control

Outcome Measures

Primary Outcomes (1)

• Local tumour control

  defined as absence of radiological local progression of the treated lesion

  24 months after treatment

Secondary Outcomes (7)

• Local Tumour Progression-Free Survival

  12 months post-treatment

• Progression-Free Survival

  12 months post-treatment

• Overall Survival

  12 months post-treatment

• Treatment-Related Toxicity

  Up to 12 months post-treatment

• Serious Adverse Events

  Up to 12 months post-treatment

Study Arms (2)

navigation bronchoscopy-guided microwave ablation

EXPERIMENTAL

Participants allocated to navigation bronchoscopy-guided microwave ablation will undergo bronchoscopic ablation according to standard institutional protocols, including navigational planning, intraprocedural imaging as per routine practice, and peri procedural care pathways. Key technical parameters will be recorded prospectively to support quality assurance and prespecified secondary analyses.

Procedure: Navigation Bronchoscopy-Guided Microwave Ablation

Stereotactic Body Radiotherapy (SBRT)

ACTIVE COMPARATOR

Participants randomized to this arm will receive stereotactic body radiotherapy according to standard radiation oncology protocols. Treatment will include simulation, target delineation, dose prescription and fractionation per routine clinical practice, and standard toxicity monitoring. Treatment parameters will be prospectively recorded.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT) RADIATION

High-precision external beam radiotherapy delivered in a limited number of fractions to the target lung lesion according to institutional and standard-of-care radiation oncology protocols.

Stereotactic Body Radiotherapy (SBRT)

Navigation Bronchoscopy-Guided Microwave Ablation PROCEDURE

Bronchoscopic delivery of microwave thermal energy to ablate the target lung lesion using navigation bronchoscopy guidance. Treatment will be performed according to institutional standards, including navigational planning, intraprocedural imaging, and standard perioperative care.

navigation bronchoscopy-guided microwave ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adults aged 18 years or above. 2. Clinically stage IA NSCLC suitable for definitive local therapy, defined as T1N0M0 with maximum tumour diameter 3 cm or less, based on routine staging work up and multidisciplinary team review.
• \. Pathological confirmation of NSCLC by histology or cytology whenever feasible. If tissue confirmation is not feasible or poses unacceptable risk, eligibility may be allowed after multidisciplinary consensus that imaging and clinical features are highly consistent with primary lung cancer, consistent with SBRT guidance for selected unbiopsied cases.
• \. Medically inoperable status, or patient declines surgery after multidisciplinary discussion, and both navigation bronchoscopy-guided microwave ablation and SBRT are considered acceptable treatment options by the treating teams (clinical equipoise).
• \. Target lesion technically suitable for both modalities, including feasibility and safety for bronchoscopy-based ablation and suitability for SBRT planning and delivery.
• \. Willing and able to provide informed consent and accept random assignment to either navigation bronchoscopy guided microwave ablation or SBRT, and able to comply with the follow up schedule.

You may not qualify if:

• \. Evidence of lymph node involvement (N1 or higher) or distant metastases (M1) on routine staging.
• \. Multiple synchronous primary lung cancers requiring different local strategies, or inability to define a single index lesion for primary endpoint assessment.
• \. Prior thoracic radiotherapy that would overlap the planned SBRT field, or prior local therapy to the index lesion.
• \. Another active malignancy that is likely to confound outcome assessment (for example, malignancy requiring systemic therapy or expected to limit 2-year survival), except adequately treated non melanoma skin cancer or in situ carcinoma with negligible recurrence risk. 5. Contraindications to bronchoscopy sedation or anaesthesia that preclude RAB or ENB guided ablation, or medical conditions that preclude SBRT positioning or safe delivery.
• \. Lesions judged unsafe or technically infeasible for either modality (for example, proximity to critical structures beyond predefined safety limits), as determined by the procedural and radiation oncology teams.
• \. Pregnant or breastfeeding women. 8. Inability or unwillingness to comply with study procedures or follow up.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Calvin Sze Hang Ng

  CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Sze Hang Ng

CONTACT

85235052618; calvinng@surgery.cuhk.edu.hk

Ng

CONTACT

+85291048780; calvinng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Environmental Foundation Professor of Thoracic Surgery

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): August 10, 2026
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

HK (1)