Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Early Phase 1

Completed

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

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Bronchoscopic Cryo-Immunotherapy (BCI)	ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)	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.

Primary Outcome Measures

Name	Time	Method
Length of Fluoroscopy Exposure during BCI	Day 0
Percentage of Successful Performances among patients in whom BCI is attempted	Day 0 (Intraoperative)	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.
Incidence of Bleeding Complications	Up to Day 7 Post-BCI
Incidence of Pneumothorax requiring Tube Thoracostomy	Up to Day 7 Post-BCI
Length of Time to Perform BCI	Day 0
Incidence of Grade 4-5 Adverse Events Potentially Related to Procedure	Up to Day 7 Post-BCI	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with peripheral blood CD8+ T cells displaying at least one combination of hypothesized markers	Up to Day 14 Post-BCI	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.

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