Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Conditions
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Advanced Non-small Cell Lung Cancer

Intervention / Treatment
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* Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bronchoscopic Cryo-Immunotherapy (BCI)<br>BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation. | Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)<br>* See BCI description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility | 1. Successful performance in at least 80% of patients in whom BCI is attempted. This will require identification of the target peripheral lung tumor by radial endobronchial ultrasound within 20 minutes followed by completed cryoablation of target tumor. | 1 Day | 
| Safety | Incidence of bleeding complications Incidence of pneumothorax Incidence of NCI Common Terminology Criteria for Adverse Events (CTCAE) grade 3, 4, or 5 adverse events which may be possibly, probably, or definitely related to BCI Maximum tolerated dose (ie, freeze time) | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of radial endobronchial ultrasound to identify peripheral lung tumor |  | 1 Day | 
| Length of time to perform BCI |  | 1 Day | 
| Length of fluoroscopy exposure during BCI |  | 1 Day | 
| Pre- and Post-BCI peripheral blood analysis |  | 14 Days | 
| Correlation of BAL PD-1 phenotype with peripheral blood |  | 14 Days |