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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
NYU Langone Health
New York, New York, United States
Percentage of Successful Performances Among Patients in Whom BCI is Attempted
Success is defined as identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor.
Time frame: Day 0 (Intraoperative)
Percentage of Patients Who Experience Bleeding Complications
Time frame: Up to Day 7 Post-BCI
Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
Time frame: Up to Day 7 Post-BCI
Length of Time to Perform BCI
Time frame: Day 0
Length of Fluoroscopy Exposure During BCI
Time frame: Day 0
Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure
Incidence of National Cancer Institute Common Terminology Criteria for Adverse Events Grade 4 or 5 adverse events that may be possibly, probably, or definitely related to BCI.
Time frame: Up to Day 7 Post-BCI
Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers
The number of patients whose peripheral blood CD8+ T cells (collected via blood sample) display at least one combination of the following markers after BCI: HLA-DR, CD38, Ki-67, Bcl-2, or PD-1.
Time frame: Up to Day 14 Post-BCI
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