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

NCT07741344 | Not Yet Recruiting Phase 2 FDA Device

• 1 other identifier: 2026.005
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage IA NSCLC

Keywords

Bronchoscopic ablation; Robotic assisted bronchoscopy; Image guided ENB; Stage IA NSCLC; disease-free survival

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS) at 24 Months

  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.

  Up to 24 months after treatment

Secondary Outcomes (18)

• 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

Study Arms (2)

Surgical Resection arm

EXPERIMENTAL

Participants undergo surgical resection for treatment of the target pulmonary lesion.

Procedure: Surgical Resection

Bronchoscopic Microwave Ablation Arm

EXPERIMENTAL

Participants undergo bronchoscopic microwave ablation for treatment of the target pulmonary lesion.

Procedure: Bronchoscopic Microwave Ablation

Interventions

Bronchoscopic Microwave Ablation PROCEDURE

The study doctor perform robotic-assisted or electromagnetic navigation bronchoscopy to locate the target lung lesion, deliver the ablation catheter through the bronchus to the target site for lesion puncture, and conduct microwave ablation. After the surgery, CBCT scanning is conducted to evaluate the ablation effect, and repeated ablation is performed as needed.

Bronchoscopic Microwave Ablation Arm

Surgical Resection PROCEDURE

The study doctor will begin by opening the hilar pleural reflection, followed by dissection of and division of lobar / segmental vein and artery by endostaplers. Segmental or lobar bronchus is dissected out and stapled. Lymphadenectomy will be performed and the specimens will be retrieved using protective bags via utility wound. This lung tissue specimen may also be analysed for research purpose.

Surgical Resection arm

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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Calvin Sze Hang Ng

  CUHK

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Sze Hang Ng

CONTACT

852-3505-2618; calvinng@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON 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 22, 2026
• First Posted: August 3, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

HK (1)