Bronchoscopic Cryo-Immunotherapy of Lung Cancer

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 Overview

• Status: Recruiting
• Conditions: Advanced Non-small Cell Lung Cancer
• Intervention / Treatment: Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Rosemary Schluger; Email: Rosemary.Schluger@nyulangone.org
• Study Contact Backup: Name: Lira Gutierrez; Phone Number: (212)263-6181; Email: Lira.Gutierrez@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Daniel Sterman, MD
      • Contact: Lira Gutierrez; Phone Number: 212-263-6181; Email: Lira.Gutierrez@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Daniel Sterman, MD, New York Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 17-00812

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No