Early Phase 1
N=21
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Advanced Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04049474 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Percentage of Successful Performances Among Patients in Whom BCI is Attempted — 100 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Successful Performances Among Patients in Whom BCI is Attempted |
100 | — |
| PRIMARY Percentage of Patients Who Experience Bleeding Complications |
— | — |
| PRIMARY Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy |
— | — |
| PRIMARY Length of Time to Perform BCI |
17 | — |
| PRIMARY Length of Fluoroscopy Exposure During BCI |
201 | — |
| PRIMARY Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure |
— | — |
| SECONDARY Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers |
50 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04049474). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.