Lung Cancer Clinical Trial
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
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 responses. The sample size for this study will be 15 patients. Pre- and post- BCI peripheral blood samples will be analyzed to assess for anti-tumor immune responses. Post-BCI peripheral blood will be collected 7 and 14 days after the procedure.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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There is 1 Location for this study
New York New York, 10016, United States More Info
Principal Investigator
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