Early feasibility test of the CAROL device for treating small (≤2 cm) stage 1 NSCLC lung tumors

To Investigate the Safety of the CAROL Device for Lung Tumour Treatment in Patients With Non-small Cell Lung Cancer Tumours(s) ≤ 2 cm (cT1b)

This study will test the CAROL device in adults with stage 1 non-small cell lung cancer (tumors ≤2 cm) to see if the treatment can be used safely.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 7 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tau-MEDICAL Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Melbourne, Victoria)
• Trial ID: NCT07122258 on ClinicalTrials.gov

What this trial studies

This early-feasibility interventional study uses the CAROL device to deliver radiofrequency ablation (RFA) to small (cT1b, ≤2 cm) non-small cell lung cancer tumors located in the outer third of the lung. Participants must be adults who are surgical candidates for lobectomy and have pathologically confirmed NSCLC at the treatment site. The procedure will apply one or more RFA applications to target the tumour margin according to a preplanned RFA plan, with the expectation that standard lobectomy would remove gross tumour. The primary outcome is safety, measured by grading adverse events with CTCAE v5.0 at one month after the procedure, and the study is conducted at Royal Melbourne Hospital under Tau Medical sponsorship.

Who should consider this trial

Good fit: Ideal candidates are adults with pathologically confirmed stage 1 NSCLC (tumour ≤2 cm, cT1b) located in the outer third of the lung who are suitable for lobectomy and can give informed consent.

Not a fit: Patients with larger (>2 cm) or centrally located tumours, non-NSCLC histology, or those who are not surgical candidates are unlikely to benefit from this study.

Why it matters

Potential benefit: If safe, the CAROL approach could provide a local ablation option for small peripheral NSCLC that may preserve lung tissue or reduce surgical morbidity.

How similar studies have performed: Thermal ablation techniques like radiofrequency ablation have shown benefit for selected small lung tumours in prior studies, but the CAROL device itself is being tested in an early-feasibility setting and is not yet proven.

Eligibility criteria

Inclusion Criteria:

Those who meet all the following criteria are eligible to participate in the clinical trial.

1. Adults 18 years of age or older at the time of screening
2. NSCLC tumour(s)≤ 2 cm (cT1b) suitable for resection
3. Suitable candidate for resection per standard of practice (Lobectomy)
4. NSCLC is confirmed pathologically for the tissue that will be ablated
5. Location of tumour:

   * ① in outer one thirds of lung (between outermost 1/3 measured by tumour centre),
   * ② if the centre of the tumour is located within the outermost 1/3, inclusion will proceed,
   * ③ anticipation that resection (lobectomy) would remove all gross tumour and ablation with grossly negative margins,
   * ④ one or more radiofrequency ablation (RFA) applications would target entire margin according to the RFA plan
6. Signed free and informed consent as prescribed by hospital policies.

Exclusion Criteria:

Those who meet any of the following criteria are excluded from this clinical trial.

1. Centralised tumour (inner most one third) not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, oesophagus or trachea)
2. Other primary lung tumours
3. Tumour is associated with vulnerable zone of pleural effusion
4. If the centre of the tumour is not located within the outermost 1/3, exclusion will proceed
5. PFT: post-bronchodilator forced expired volume in on second (FEV1) or forced vital capacity (FVC) ≤60% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 50% predicted
6. Patients with evidence of severe chronic pulmonary disease including asthma, Chronic Obstructive Pulmonary Disease (COPD), or Interstitial Lung Disease (ILD).
7. Requirement of supplemental oxygen at rest or exercise
8. Hospitalization for cardiac disease within the preceding 3 months
9. Liver enzymes (Alanine Aminotransferase \[ALT\], Alkaline Phosphatase \[ALP\], Aspartate Aminotransferase \[AST\]) or total bilirubin \>1.5 upper limit of normal (ULN)
10. Serum creatinine \> 2 mg/dl
11. Recent infection (within 30 days)
12. Receiving immunosuppressive medication or prednisone \> 20 mg/day (or equivalent)
13. Pre-existing implants - either within the airways or any other location - that impede navigation to or visualisation of the target lesion, in the opinion of the investigator
14. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
15. Disorder of coagulation, history of severe haemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedures and 10 days post-procedures, where this refers to both the ablation and surgical procedures
16. Any condition or anatomical factor that, in the opinion of the investigator or reviewer, may interfere with the safety of the patient, the conduct of the procedure, or evaluation of the study objectives (e.g. severe bronchial narrowing, wall compromise)
17. Any tumour characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
18. Contraindication to complete neuromuscular blockade during the ablation procedure
19. Implantable cardiac devices such as pacemakers or defibrillators, especially with unipolar electrode configurations
20. Known hypersensitivity or allergy to gallium, indium, or other components of the conformable electrode
21. Medically inoperable conditions
22. Participant who is currently participating in, or planning to participate in (during the course of the trial), another non-observational clinical research study
23. Participants who have participated in a non-observational clinical research study within either the past 30 days or who are still within the intervention's wash-out period (whichever is longer)
24. Participant who, in the opinion of the investigator, is not suitable for participation in the study

Where this trial is running

Melbourne, Victoria

• Royal Melbourne Hospital — Melbourne, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Daniel Steinfort, MD, PhD

Conditions NSCLC; CAROL; TAU MEDICAL