The REMOVE Study - Endobronchial Thermal Liquid Ablation - Lung Cancer (ETLA-LC) for the Treatment of Pulmonary Cancer Lesions - A First in Human Treat and Resect Study (CSP-21123)

Not Applicable

• Conditions: ung Cancer; Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12624001045505
• Lead Sponsor: Morair Medtech, Pty. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-28
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

General Inclusion Criteria
-Age greater than or equal to 18 years old
-Non-small cell lung cancer tumor(s) suitable for lobectomy
-Suitable candidate for lobectomy as per standard of care
-Pathologically confirmed malignancy obtained via bronchoscopic biopsy with adequate yield to perform definitive diagnosis
-Cognitively able to provide written informed consent

Radiographic Inclusion Criteria
-Longest axis of tumor less than 3cm per HRCT analysis by QCT Core lab
-Tumor is identified in the periphery of lung (outer 2/3rd) by radiologic reviewer in addition to site radiologist.
-Tumor resides in eligible segment(s) per HRCT analysis by QCT Core lab, with target treatment location not adjacent to lobar fissure planned for resection, and assessed by surgeon
-Tumor resides within two or fewer eligible segments per HRCT analysis by QCT Core lab with treatment at the segmental or subsegmental level.

Exclusion Criteria

General Exclusion Criteria
-Post-bronchodilator FEV1 of less than 40% predicted or recent COPD exacerbation requiring treatment within 1 year of screening
-DLCO less than 40% predicted
-Supplemental oxygen at rest or during exercise
-Hospitalization for cardiac event within 6 months of screening
-Liver enzymes (AST, ALT, ALP) or total bilirubin more than 1.5 times upper limit of normal (ULN)
-Serum creatinine greater than 2 mg/dL
-Receiving immunosuppressive medication or prednisone greater than 15 mg/day (or equivalent)
-Receiving adjunct chemotherapy
-Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.
-History of severe hemoptysis or persistent hemoptysis.
-Disorder of coagulation or receiving anticoagulant and/or antiplatelet medication.

Note: Antiplatelet/anticoagulant medication is permitted provided that the medication can be held per physician discretion based on specific agent prior to the procedure and through to planned surgical resection.

-Unablated tumor tissue is required from the resection to inform patient’s ongoing cancer treatment.
-Any condition that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
-Any condition that would interfere with completion of the study including study assessments and procedures.
-Any tumor characteristic that in the opinion of the investigator may interfere with the safety of the patient or evaluation of the study objectives.
-Currently enrolled in another trial studying an experimental treatment that in the opinion of the investigator may impact this study.

Radiographic Exclusion Criteria
-Tumor invading beyond pleura into chest wall
NOTE: HRCT analysis by QCT Core Lab
Tumor invading beyond pleura into check wall assessed by Radiologic Eligibility Reviewer in addition to site radiology

Pre-procedural Exclusion Criteria
-Active respiratory infection or recent respiratory infection with resolution less than 4 weeks prior to screening or procedure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified