Status:
COMPLETED
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Lead Sponsor:
NYU Langone Health
Conditions:
Advanced Non-small Cell Lung Cancer
Eligibility:
All Genders
22-80 years
Phase:
EARLY_PHASE1
Brief Summary
This is a safety and feasibility study of bronchoscopic cryo-immunotherapy (BCI) of peripheral lung tumors in advanced non-small cell lung cancer for the intention of inducing anti-tumor immune respon...
Eligibility Criteria
Inclusion
- Peripheral lung tumor on pre-procedure chest CT scan, which is known or suspected to be advanced, inoperable non-small cell lung cancer (stages IIIA/B/C and IVA/B) based on the 8th edition TNM staging guidelines
- Pre-procedure chest CT scan with the presence of a bronchus or airway path leading directly to the peripheral lung tumor (also known as a "bronchus sign")
- Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study.
- Documentation of non-small cell lung cancer either prior to procedure or via on-site pathology review during bronchoscopy (prior to proceeding with planned BCI)
- Ability to provide informed consent
- Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
- ECOG performance status less than or equal to 2
Exclusion
- Pregnancy
- Currently on a platelet inhibitor (such as Clopidogrel) other than aspirin or NSAIDS, or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy
- INR \>= 1.5 (post correction)
- Platelets =\< 100,000 (post correction)
- Bleeding diathesis
- Contraindication to bronchoscopy
- Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.
Key Trial Info
Start Date :
February 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04049474
Start Date
February 15 2020
End Date
April 9 2024
Last Update
April 24 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016