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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Bronchoscopic Microwave Ablation
  • Surgical Resection

Treatment groups

292 Participants
are divided into 2 treatment groups