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CompletedEarly Phase 1NCT04049474
Official study title

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 24, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Early Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?NYU Langone Health

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Early Phase 1
Sponsor
NYU Langone Health
Interventions being studied
Device: ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Surgery→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NYU Langone HealthNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 24, 2025. Always confirm current availability with the study team.

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