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Stage IA NSCLCPhase 2NCT07741344

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

A Phase 2 study testing Bronchoscopic Microwave Ablation and Surgical Resection in people with Stage IA NSCLC, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stage IA NSCLC
What is being tested?
Bronchoscopic Microwave Ablation and Surgical Resection
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
1 siteHong Kong
Study dates
1 Nov 2026to 31 Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Calvin Sze Hang Ng contact

852-3505-2618

calvinng@surgery.cuhk.edu.hk

Hong Kong1 site

  • Prince of Wales Hospital

    Hong Kong

    Calvin Sze Hang Ng, 852-3505-2618, calvinng@surgery.cuhk.edu.hk

    Calvin Sze Hang Ng

Other trials in Hong Kong

About this study

Official title: 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

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
Being tested
Bronchoscopic Microwave Ablation, Surgical Resection
Keywords
Bronchoscopic ablation, Robotic assisted bronchoscopy, Image guided ENB, Stage IA NSCLC, disease-free survival
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bronchoscopic Microwave AblationProcedure or surgery

    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.

  • Surgical ResectionProcedure or surgery

    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.

Study groups in NCT07741344
Study groupRoleWhat they receive
Surgical Resection armExperimentalParticipants undergo surgical resection for treatment of the target pulmonary lesion.
Receives: Procedure: Surgical Resection
Bronchoscopic Microwave Ablation ArmExperimentalParticipants undergo bronchoscopic microwave ablation for treatment of the target pulmonary lesion.
Receives: Procedure: Bronchoscopic Microwave Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months after treatment

Secondary outcomes (18)

  1. Overall Survival

    Comparison of overall survival between treatment groups. OS is defined as the time from treatment to death from any cause.

    Measured: Up to 24 months after treatment

  2. Local Tumor Control Rate

    Proportion of participants without local recurrence at the treated lesion site.

    Measured: Up to 24 months after treatment

  3. Time to Recurrence

    Time from treatment to first documented local, regional, or distant recurrence.

    Measured: Up to 36 months after treatment

  4. Cancer-Specific Mortality

    Death attributable to lung cancer.

    Measured: Up to 36 months after treatment

  5. Major Procedure-Related Complications

    Incidence of major complications requiring intervention, hospitalization, or resulting in significant morbidity.

    Measured: 30 days and 90 days after treatment

  6. Procedure-Related Adverse Events

    Incidence and severity of treatment-related adverse events.

    Measured: 30 days and 90 days after treatment

  7. Procedure-Related Mortality

    Death attributable to the study procedure.

    Measured: 30 days and 90 days after treatment

  8. Forced Expiratory Volume in One Second (FEV1)

    Change from baseline in forced expiratory volume in one second (FEV1), percent predicted.

    Measured: 6, 12, 24, and 36 months after treatment and Baseline

  9. Health-Related Quality of Life

    Change from baseline in health-related quality of life measured using the EuroQol 5 Dimensions (EQ-5D) questionnaire.

    Measured: 6, 12, 24, and 36 months after treatment and baseline

  10. Functional Exercise Capacity

    Change from baseline in six-minute walk distance (Description in questionnaire)

    Measured: 6, 12, 24, and 36 months & Baseline

  11. Return to Usual Activities

    Time from treatment until resumption of usual daily activities.

    Measured: Up to 36 months after treatment

  12. Post-Treatment Analgesic Use

    Duration and intensity of analgesic medication use following treatment.

    Measured: Up to 36 months after treatment

  13. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

    Change from baseline in diffusing capacity of the lung for carbon monoxide (DLCO), percent predicted.

    Measured: Baseline; 6, 12, 24, and 36 months after treatment

  14. ctDNA Clearance Rate

    Percentage of participants achieving circulating tumor DNA (ctDNA) clearance, defined as the absence of detectable ctDNA in plasma using the study ctDNA assay.

    Measured: Baseline; 1 month and 6 months after treatment

  15. Change in ctDNA Level

    Logarithmic fold change in circulating tumor DNA (ctDNA) levels from baseline, measured using the study ctDNA assay

    Measured: Baseline; 1 month and 6 months after treatment

  16. Change in Immune Activation Biomarker Signature Score

    Change from baseline in immune activation biomarker signature score, measured using [specify assay/platform, e.g., RNA sequencing, NanoString immune profiling panel, multiplex immunoassay

    Measured: Baseline and 36 months after treatment

  17. Correlation Between Immune Activation Biomarker Signature Score and Duration of Response

    Correlation between immune activation biomarker signature score measured using [assay/platform] and duration of response.

    Measured: duration of response assessed up to 36 months after treatment

  18. Correlation Between Immune Activation Biomarker Signature Score and Overall Survival

    Correlation between immune activation biomarker signature score measured using [assay/platform] and overall survival

    Measured: assessed up to 36 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07741344
Sponsor's protocol ID
2026.005
Status last verified
Oct 2026
First submitted
22 Jul 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bronchoscopic Microwave Ablation and Surgical Resection in people with Stage IA NSCLC, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Calvin Sze Hang Ng (852-3505-2618, calvinng@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (DFS) at 24 Months (time frame: Up to 24 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07741344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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