Lung Cancer (NSCLC)Phase 2NCT07722182
Navigation Bronchoscopy Guided Microwave Ablation Versus SBRT in Early NSCLC
A Phase 2 study testing Navigation Bronchoscopy-Guided Microwave Ablation and Stereotactic Body Radiotherapy (SBRT) in people with Lung Cancer (NSCLC), run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Navigation Bronchoscopy-Guided Microwave Ablation and Stereotactic Body Radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 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
- 1. Adults aged 18 years or above. 2. Clinically stage IA NSCLC suitable for definitive local therapy, defined as T1N0M0 with maximum tumour diameter 3 cm or less, based on routine staging work up and multidisciplinary team review.
- 3. Pathological confirmation of NSCLC by histology or cytology whenever feasible. If tissue confirmation is not feasible or poses unacceptable risk, eligibility may be allowed after multidisciplinary consensus that imaging and clinical features are highly consistent with primary lung cancer, consistent with SBRT guidance for selected unbiopsied cases.
- 4. Medically inoperable status, or patient declines surgery after multidisciplinary discussion, and both navigation bronchoscopy-guided microwave ablation and SBRT are considered acceptable treatment options by the treating teams (clinical equipoise).
- 5. Target lesion technically suitable for both modalities, including feasibility and safety for bronchoscopy-based ablation and suitability for SBRT planning and delivery.
- 6. Willing and able to provide informed consent and accept random assignment to either navigation bronchoscopy guided microwave ablation or SBRT, and able to comply with the follow up schedule.
Who cannot join
- 1. Evidence of lymph node involvement (N1 or higher) or distant metastases (M1) on routine staging.
- 2. Multiple synchronous primary lung cancers requiring different local strategies, or inability to define a single index lesion for primary endpoint assessment.
- 3. Prior thoracic radiotherapy that would overlap the planned SBRT field, or prior local therapy to the index lesion.
- 4. Another active malignancy that is likely to confound outcome assessment (for example, malignancy requiring systemic therapy or expected to limit 2-year survival), except adequately treated non melanoma skin cancer or in situ carcinoma with negligible recurrence risk. 5. Contraindications to bronchoscopy sedation or anaesthesia that preclude RAB or ENB guided ablation, or medical conditions that preclude SBRT positioning or safe delivery.
- 6. Lesions judged unsafe or technically infeasible for either modality (for example, proximity to critical structures beyond predefined safety limits), as determined by the procedural and radiation oncology teams.
- 7. Pregnant or breastfeeding women. 8. Inability or unwillingness to comply with study procedures or follow up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Prince of Wales Hospital
Hong Kong
Calvin Sze Hang Ng, 85235052618, calvinng@surgery.cuhk.edu.hk
About this study
Official title: A Pragmatic Randomised Trial Comparing Navigation Bronchoscopy-guided Microwave Ablation Versus Stereotactic Body Radiotherapy for Medically Inoperable or Surgery-declining Early-stage Non-small Cell Lung Cancer
Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited.
Objective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC.
Read more
Methods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT.
Surveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation.
Impact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Navigation Bronchoscopy-Guided Microwave Ablation, Stereotactic Body Radiotherapy (SBRT)
- Keywords
- Non-small cell lung cancer, navigation bronchoscopy, robotic assisted bronchoscopy, microwave ablation, stereotactic body radiotherapy, pragmatic randomised trial, local tumour control
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation Bronchoscopy-Guided Microwave AblationProcedure or surgery
Bronchoscopic delivery of microwave thermal energy to ablate the target lung lesion using navigation bronchoscopy guidance. Treatment will be performed according to institutional standards, including navigational planning, intraprocedural imaging, and standard perioperative care.
Stereotactic Body Radiotherapy (SBRT)Radiation
High-precision external beam radiotherapy delivered in a limited number of fractions to the target lung lesion according to institutional and standard-of-care radiation oncology protocols.
| Study group | Role | What they receive |
|---|---|---|
| navigation bronchoscopy-guided microwave ablation | Experimental | Participants allocated to navigation bronchoscopy-guided microwave ablation will undergo bronchoscopic ablation according to standard institutional protocols, including navigational planning, intraprocedural imaging as per routine practice, and peri procedural care pathways. Key technical parameters will be recorded prospectively to support quality assurance and prespecified secondary analyses. Receives: Procedure: Navigation Bronchoscopy-Guided Microwave Ablation |
| Stereotactic Body Radiotherapy (SBRT) | Active comparator | Participants randomized to this arm will receive stereotactic body radiotherapy according to standard radiation oncology protocols. Treatment will include simulation, target delineation, dose prescription and fractionation per routine clinical practice, and standard toxicity monitoring. Treatment parameters will be prospectively recorded. Receives: Radiation: Stereotactic Body Radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumour control
defined as absence of radiological local progression of the treated lesion
Measured: 24 months after treatment
Secondary outcomes (7)
Local Tumour Progression-Free Survival
Time from treatment initiation to local tumour progression or death from any cause.
Measured: 12 months post-treatment
Progression-Free Survival
Time from treatment initiation to disease progression (local or distant) or death from any cause.
Measured: 12 months post-treatment
Overall Survival
Time from treatment initiation to death from any cause.
Measured: 12 months post-treatment
Treatment-Related Toxicity
Incidence and severity of treatment-related toxicities graded according to CTCAE version 5.0.
Measured: Up to 12 months post-treatment
Serious Adverse Events
Number of participants experiencing serious adverse events (SAEs).
Measured: Up to 12 months post-treatment
Quality of Life
Change in patient-reported quality of life scores measured using [questionnaire name, e.g., EORTC QLQ-C30].
Measured: Baseline to 12 months post-treatment
Healthcare Utilisation
Number of hospital visits, unplanned hospital admissions, and retreatment episodes following treatment.
Measured: Up to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calvin Sze Hang Ng, Chinese University of Hong Kong
- Investigators
- Calvin Sze Hang Ng, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722182
- Sponsor's protocol ID
- 2026.364
- Status last verified
- Oct 2026
- First submitted
- 20 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomised Trial Comparing Navigation Bronchoscopy-guided Microwave Ablation Versus Stereotactic Body Radiotherapy for Medically Inoperable or Surgery-declining Early-stage Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07722182
- Acronym / sponsor ID
- 2026.364
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Non-small cell lung cancer, navigation bronchoscopy, robotic assisted bronchoscopy, microwave ablation, stereotactic body radiotherapy, pragmatic randomised trial, local tumour control
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Stereotactic body radiotherapy (SBRT) is a standard definitive local therapy for medically inoperable early stage non-small cell lung cancer (NSCLC). Navigation bronchoscopy guided microwave ablation is an emerging alternative that may reduce treatment burden and avoid ionising radiation. However, comparative evidence against SBRT remains limited.
Objective: To generate relevant comparative evidence to inform treatment selection for medically inoperable patients or patients who decline surgery with early-stage NSCLC.
Methods: This is a Hong Kong led, pragmatic, multicentre, parallel group randomised controlled clinical trial with open label treatment delivery and blinded end point assessment. Eligible participants will be randomised one to one to navigation bronchoscopy guided microwave ablation or SBRT.
Surveillance includes scheduled chest computed tomography at 1, 3, 6, 12, 18, and 24 months, with independent blinded imaging adjudication using a prespecified review charter. The primary end point is 24-month local tumour control, defined as absence of local progression of the treated lesion. The primary analysis will follow intention to treat and will test noninferiority using an absolute risk difference margin of 0.15. Secondary outcomes include time to local progression, progression free survival, overall survival, treatment related toxicity and serious adverse events, patient reported outcomes including quality of life trajectories, and healthcare utilisation such as hospital visits, unplanned admissions, and retreatment. The target sample size is 100 participants, providing adequate power for the prespecified noninferiority margin and supporting secondary outcome estimation.
Impact: Findings will directly inform multidisciplinary decision making, local pathway design, and service planning in Hong Kong and collaborating centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigation bronchoscopy-guided microwave ablation | Experimental | Procedure: Navigation Bronchoscopy-Guided Microwave AblationParticipants allocated to navigation bronchoscopy-guided microwave ablation will undergo bronchoscopic ablation according to standard institutional protocols, including navigational planning, intraprocedural imaging as per routine practice, and peri procedural care pathways. Key technical parameters will be recorded prospectively to support quality assurance and prespecified secondary analyses. |
| Stereotactic Body Radiotherapy (SBRT) | Active comparator | Radiation: Stereotactic Body Radiotherapy (SBRT)Participants randomized to this arm will receive stereotactic body radiotherapy according to standard radiation oncology protocols. Treatment will include simulation, target delineation, dose prescription and fractionation per routine clinical practice, and standard toxicity monitoring. Treatment parameters will be prospectively recorded. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Adults aged 18 years or above. 2. Clinically stage IA NSCLC suitable for definitive local therapy, defined as T1N0M0 with maximum tumour diameter 3 cm or less, based on routine staging work up and multidisciplinary team review.
- 3. Pathological confirmation of NSCLC by histology or cytology whenever feasible. If tissue confirmation is not feasible or poses unacceptable risk, eligibility may be allowed after multidisciplinary consensus that imaging and clinical features are highly consistent with primary lung cancer, consistent with SBRT guidance for selected unbiopsied cases.
- 4. Medically inoperable status, or patient declines surgery after multidisciplinary discussion, and both navigation bronchoscopy-guided microwave ablation and SBRT are considered acceptable treatment options by the treating teams (clinical equipoise).
- 5. Target lesion technically suitable for both modalities, including feasibility and safety for bronchoscopy-based ablation and suitability for SBRT planning and delivery.
- 6. Willing and able to provide informed consent and accept random assignment to either navigation bronchoscopy guided microwave ablation or SBRT, and able to comply with the follow up schedule.
Key exclusion criteria (6 listed)
- 1. Evidence of lymph node involvement (N1 or higher) or distant metastases (M1) on routine staging.
- 2. Multiple synchronous primary lung cancers requiring different local strategies, or inability to define a single index lesion for primary endpoint assessment.
- 3. Prior thoracic radiotherapy that would overlap the planned SBRT field, or prior local therapy to the index lesion.
- 4. Another active malignancy that is likely to confound outcome assessment (for example, malignancy requiring systemic therapy or expected to limit 2-year survival), except adequately treated non melanoma skin cancer or in situ carcinoma with negligible recurrence risk. 5. Contraindications to bronchoscopy sedation or anaesthesia that preclude RAB or ENB guided ablation, or medical conditions that preclude SBRT positioning or safe delivery.
- 6. Lesions judged unsafe or technically infeasible for either modality (for example, proximity to critical structures beyond predefined safety limits), as determined by the procedural and radiation oncology teams.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation Bronchoscopy-Guided Microwave AblationBronchoscopic delivery of microwave thermal energy to ablate the target lung lesion using navigation bronchoscopy guidance. Treatment will be performed according to institutional standards, including navigational planning, intraprocedural imaging, and standard perioperative care. | Procedure or surgery | navigation bronchoscopy-guided microwave ablation |
| Stereotactic Body Radiotherapy (SBRT)High-precision external beam radiotherapy delivered in a limited number of fractions to the target lung lesion according to institutional and standard-of-care radiation oncology protocols. | Radiation | Stereotactic Body Radiotherapy (SBRT) |
Primary outcome
Local tumour control
Time frame: 24 months after treatment
defined as absence of radiological local progression of the treated lesion
7 secondary outcomes
Local Tumour Progression-Free Survival
Time frame: 12 months post-treatment
Progression-Free Survival
Time frame: 12 months post-treatment
Overall Survival
Time frame: 12 months post-treatment
Treatment-Related Toxicity
Time frame: Up to 12 months post-treatment
Serious Adverse Events
Time frame: Up to 12 months post-treatment
Quality of Life
Time frame: Baseline to 12 months post-treatment
Healthcare Utilisation
Time frame: Up to 12 months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Calvin Sze Hang Ng principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Navigation Bronchoscopy-Guided Microwave Ablation and Stereotactic Body Radiotherapy (SBRT) in people with Lung Cancer (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 5 inclusion and 6 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 (85235052618, 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?
Local tumour control (time frame: 24 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.