Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Advanced Non-small Cell Lung Cancer Clinical Trial

Official title:

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04049474
• Other study ID #: 17-00812
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 15, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Lira Gutierrez
• Phone: (212)263-6181
• Email: Lira.Gutierrez[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 80 Years

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.

Related Conditions & MeSH terms

• Advanced Non-small Cell Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ability of radial endobronchial ultrasound to identify peripheral lung tumor		1 Day
Secondary	Length of time to perform BCI		1 Day
Secondary	Length of fluoroscopy exposure during BCI		1 Day
Secondary	Pre- and Post-BCI peripheral blood analysis		14 Days
Secondary	Correlation of BAL PD-1 phenotype with peripheral blood		14 Days