NCT07741344Not yet recruitingPhase 2

Study of Robotic Assisted/Image Guided Electromagnetic Navigation Bronchoscopic Therapies and Surgery in Stage IA NSCLC

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

Source: ClinicalTrials.gov · Last updated 21 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 292 (estimated)
First submitted: 22 Jul 2026
Start date: 1 Nov 2026
Primary completion date: 30 Nov 2026
Lead sponsor: Chinese University of Hong Kong
Diseases: Lung cancer
NCT number: NCT07741344

What you commit to

Study type: Interventional · Phase 2
Planned participants: 292
From 1 Nov 2026 to the primary completion date, 30 Nov 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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
Presence of electronic implants (e.g., pacemaker or defibrillator) at risk of interference from microwave energy
Patients with multiple lesions requiring both surgery and ablation who cannot represent a single treatment strategy within the study
- Surgical Resection Group Inclusion Criteria
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.
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
High surgical risk or limited pulmonary reserve where a lung-preserving strategy is preferred.
Patients with multiple lesions, some requiring surgery and others ablation, who cannot be assigned to a single treatment strategy within the study.

Other illness

Active pulmonary infection, uncorrectable coagulopathy, or ASA score ≥4
Active pulmonary infection, uncorrectable coagulopathy, or unfit for general anaesthesia or lung resection.

Age

Adults aged ≥18 years

Other

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
Pregnant or breastfeeding women
Inability or unwillingness to comply with study procedures
Histologically or cytologically confirmed stage IA NSCLC (T1N0M0, tumor ≤3 cm)
Imaging findings suggest possible lymph node involvement or a clinical indication for systematic nodal dissection and pathological staging.
Presence of lymph node involvement (N1 or higher) or distant metastases (M1)
Tumours clearly suitable for ablation (≤2.5 cm, located in the middle or peripheral third, and safely ablatable with adequate margins).
Pregnant or breastfeeding women
Inability or unwillingness to comply with study procedures

Criteria the registry did not label

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Prince of Wales Hospital Coordinator of this site? Confirm its status	Hong Kong	Hong Kong SAR China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.