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Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Primary Purpose

Advanced Non-small Cell Lung Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small Cell Lung Cancer

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bronchoscopic Cryo-Immunotherapy (BCI)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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)

Secondary Outcome Measures

Ability of radial endobronchial ultrasound to identify peripheral lung tumor
Length of time to perform BCI
Length of fluoroscopy exposure during BCI
Pre- and Post-BCI peripheral blood analysis
Correlation of BAL PD-1 phenotype with peripheral blood

Full Information

First Posted
August 6, 2019
Last Updated
May 9, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT04049474
Brief Title
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Official Title
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bronchoscopic Cryo-Immunotherapy (BCI)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)
Intervention Description
See BCI description.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
1 Day
Title
Safety
Description
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)
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
Ability of radial endobronchial ultrasound to identify peripheral lung tumor
Time Frame
1 Day
Title
Length of time to perform BCI
Time Frame
1 Day
Title
Length of fluoroscopy exposure during BCI
Time Frame
1 Day
Title
Pre- and Post-BCI peripheral blood analysis
Time Frame
14 Days
Title
Correlation of BAL PD-1 phenotype with peripheral blood
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lira Gutierrez
Phone
(212)263-6181
Email
Lira.Gutierrez@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Rosemary Schluger
Email
Rosemary.Schluger@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Sterman, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lira Gutierrez
Phone
212-263-6181
Email
Lira.Gutierrez@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Daniel Sterman, MD

12. IPD Sharing Statement

Learn more about this trial

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

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