Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Bronchoscopic Cryo-Immunotherapy (BCI) 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)
See BCI description.
|
Outcome Measures
Primary Outcome Measures
- Feasibility [1 Day]
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.
- Safety [7 Days]
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)
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
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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")
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Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study.
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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
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Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
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ECOG performance status less than or equal to 2
Exclusion Criteria:
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Pregnancy
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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
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INR >= 1.5 (post correction)
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Platelets =< 100,000 (post correction)
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Bleeding diathesis
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Contraindication to bronchoscopy
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Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Daniel Sterman, MD, New York Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-00812