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Completed

NCT Number: NCT04049474

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.

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Key information

Conditions

Advanced Non-Small Cell Lung Cancer

Age range

22 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

See BCI description.

Primary outcomes

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

    Time frame: 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.

  2. Percentage of Patients Who Experience Bleeding Complications

    Time frame: Up to Day 7 Post-BCI

  3. Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy

    Time frame: Up to Day 7 Post-BCI

  4. Length of Time to Perform BCI

    Time frame: Day 0

  5. Length of Fluoroscopy Exposure During BCI

    Time frame: Day 0

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2019
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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