NCT07741344Not yet recruitingPhase 2
A Dual-Phase Study Comparing Survival, Immune Activation, and Functional Preservation Between Robotic-assisted / Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC
Chinese University of Hong Kong1 site in 1 country292 target enrollmentStarted: July 31, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 292
- Locations
- 1
- Primary Endpoint
- Disease-Free Survival (DFS) at 24 Months
Study Overview
Brief Summary
This study aims to address the core deficiencies in the field by situating bronchoscopic ablation within the same evidentiary frame as segmentectomy and lobectomy. It will deliver adjusted retrospective comparisons with external validation using population data, a prospective noninferiority evaluation on disease control and safety, quantitative evidence on pulmonary function and quality of life, and translational endpoints linking circulating tumour DNA (ctDNA) dynamics and immune activation to durability of control. The work is directly aligned with Hong Kong service needs, where a safe lung preserving option that shortens recovery and optimises resource use could relieve surgical waiting pressure while maintaining oncologic outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Bronchoscopic Microwave Ablation Group Inclusion Criteria
- •Adults aged ≥18 years
- •Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- •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
- •Tumour size less than 2.5 cm in maximum diameter as measured on thin-slice chest CT
- •Tumour located in the middle or peripheral third of the lung parenchyma
- •Imaging and clinical evaluation indicate no lymph node involvement, and lymph node dissection for staging is not required
- •Medically fit for bronchoscopic procedure under standard institutional anaesthesia protocols
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Exclusion Criteria
- •Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- •Centrally located tumours within the inner third of the lung or those requiring ablation near major airways
- •Tumours adjacent to heat-sensitive structures (e.g., main bronchi, oesophagus, pericardium, aorta, or pulmonary artery) where adequate ablation margins cannot be safely achieved
- •Rapidly enlarging lesions or those with high metabolic activity on PET-CT that warrant surgical resection and lymph node evaluation
- •Imaging findings suggesting possible nodal involvement that necessitate surgical dissection for accurate staging
- •Pregnant or breastfeeding women
- •Inability or unwillingness to comply with study procedures
- •Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy
- •Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4
- •Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study
- •Surgical Resection Group Inclusion Criteria
- •Adults aged ≥18 years
- •Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
- •Determined by multidisciplinary evaluation to have surgical resection as the preferred standard treatment option, and patient agrees to surgical resection.
- •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.
- •Tumour located in the central third of the lung, or in proximity to heat-sensitive structures where surgery offers better oncologic and safety margins.
- •Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging.
- •Rapidly growing or high-SUV lesions on PET-CT requiring complete resection and full histologic staging.
- •Medically fit for general anaesthesia and surgical resection, with capability for intraoperative frozen-section margin assessment
- •Exclusion Criteria
- •Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
- •High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred.
- •Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins).
- •Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection.
- •Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study.
- •Pregnant or breastfeeding women
- •Inability or unwillingness to comply with study procedures
Outcomes
Primary Outcomes
Disease-Free Survival (DFS) at 24 Months
Time Frame: Up to 24 months after treatment
To determine whether bronchoscopic microwave ablation is non-inferior to segmentectomy or lobectomy with respect to disease-free survival (DFS) at 24 months in eligible patients with stage IA lung cancer. DFS is defined as the time from treatment to disease recurrence, progression, or death from any cause.
Secondary Outcomes
- Overall Survival(Up to 24 months after treatment)
- Local Tumor Control Rate(Up to 24 months after treatment)
- Time to Recurrence(Up to 36 months after treatment)
- Cancer-Specific Mortality(Up to 36 months after treatment)
- Major Procedure-Related Complications(30 days and 90 days after treatment)
- Procedure-Related Adverse Events(30 days and 90 days after treatment)
- Procedure-Related Mortality(30 days and 90 days after treatment)
- Forced Expiratory Volume in One Second (FEV1)(6, 12, 24, and 36 months after treatment and Baseline)
- Health-Related Quality of Life(6, 12, 24, and 36 months after treatment and baseline)
- Functional Exercise Capacity(6, 12, 24, and 36 months & Baseline)
- Return to Usual Activities(Up to 36 months after treatment)
- Post-Treatment Analgesic Use(Up to 36 months after treatment)
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Baseline; 6, 12, 24, and 36 months after treatment)
- ctDNA Clearance Rate(Baseline; 1 month and 6 months after treatment)
- Change in ctDNA Level(Baseline; 1 month and 6 months after treatment)
- Change in Immune Activation Biomarker Signature Score(Baseline and 36 months after treatment)
- Correlation Between Immune Activation Biomarker Signature Score and Duration of Response(duration of response assessed up to 36 months after treatment)
- Correlation Between Immune Activation Biomarker Signature Score and Overall Survival(assessed up to 36 months after treatment)
Investigators
Calvin Sze Hang Ng
Environmental Foundation Professor of Thoracic Surgery
Chinese University of Hong Kong
Study Sites (1)
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