NCT04049474

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Completed EARLY_PHASE1 Results posted Last updated 24 April 2025

What this trial tests

EARLY_PHASE1 trial testing ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany) in Advanced Non-small Cell Lung Cancer in 21 participants. Completed in 9 April 2024.

Timeline

15 February 2020

Primary endpoint
9 April 2024

9 April 2024

Quick facts

Lead sponsor	NYU Langone Health
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	15 February 2020
Primary completion	9 April 2024
Estimated completion	9 April 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Advanced Non-small Cell Lung Cancer — all drugs for Advanced Non-small Cell Lung Cancer →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 22 to 80, any sex, with Advanced Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Successful Performances Among Patients in Whom BCI is Attempted Primary · 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.

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	100

Percentage of Patients Who Experience Bleeding Complications Primary · Up to Day 7 Post-BCI

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	0

Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy Primary · Up to Day 7 Post-BCI

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	0

Length of Time to Perform BCI Primary · Day 0

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	17	11.5 – 32.65

Length of Fluoroscopy Exposure During BCI Primary · Day 0

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	201	135 – 284.5

Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure Primary · 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.

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	0

Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers Secondary · 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.

Group	Value	95% CI
Bronchoscopic Cryo-Immunotherapy (BCI)	50

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cryoablation and immunity in non-small cell lung cancer: a new era of cryo-immunotherapy.
   Velez A, DeMaio A, Sterman D. · · 2023 · cited 21× · PMID 37671163 · DOI 10.3389/fimmu.2023.1203539
2. Combined with interventional therapy, immunotherapy can create a new outlook for tumor treatment.
   Fang T, Xiao J, Zhang Y, Hu H, et al · · 2021 · cited 8× · PMID 34079746 · DOI 10.21037/qims-20-173
3. CRYOVATE: A Pilot Study of Lung Cancer Cryoactivation in Combination With Immunotherapy in Advanced NSCLC.
   Desilets A, Pinheiro G, Belkaid W, Salko O, et al · · 2024 · cited 5× · PMID 39624249 · DOI 10.1016/j.jtocrr.2024.100737
4. ERJ Advances: interventional bronchoscopy.
   Garner JL, Shah PL, Herth F, Slebos DJ. · · 2024 · cited 3× · PMID 38991719 · DOI 10.1183/13993003.01946-2023
5. A Phase I Dose-Escalation Clinical Trial of Bronchoscopic Cryoimmunotherapy in Advanced-Stage NSCLC.
   Tsay JJ, Velez A, Collazo D, Laniado I, et al · · 2025 · cited 2× · PMID 40678346 · DOI 10.1016/j.jtocrr.2025.100849
6. Early Effects of Bronchoscopic Cryotherapy in Metastatic Non-Small Cell Lung Cancer Patients Receiving Immunotherapy: A Single-Center Prospective Study.
   Vasiliauskas G, Žemaitė E, Skrodenienė E, Poškienė L, et al · · 2025 · cited 2× · PMID 39857085 · DOI 10.3390/diagnostics15020201
7. [Current Status and Progress of Thermal Ablation Combined with Immunotherapy for Lung Tumors].
   Liu B. · · 2022 · cited 1× · PMID 35477191 · DOI 10.3779/j.issn.1009-3419.2022.102.09