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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Experimental | BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany) | Device | See BCI description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Successful Performances Among Patients in Whom BCI is Attempted | 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. | Day 0 (Intraoperative) |
| Percentage of Patients Who Experience Bleeding Complications | Up to Day 7 Post-BCI | |
| Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy | Up to Day 7 Post-BCI | |
| Length of Time to Perform BCI | Day 0 | |
| Length of Fluoroscopy Exposure During BCI | Day 0 | |
| Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure | 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. | Up to Day 7 Post-BCI |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers | 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. | Up to Day 14 Post-BCI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sterman, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bronchoscopic Cryo-Immunotherapy (BCI) | BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation. ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bronchoscopic Cryo-Immunotherapy (BCI) | BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation. ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Successful Performances Among Patients in Whom BCI is Attempted | 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. | Posted | Number | Percentage of participants | Day 0 (Intraoperative) |
|
12 months
Systematic - chart review per protocol timelines
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bronchoscopic Cryo-Immunotherapy (BCI) | BCI is performed by advancing a flexible cryoprobe through a bronchoscope to reach a peripheral tumor. The cryoprobe is activated to freeze a portion of the tumor. The cryoprobe is allowed to thaw to prevent removal of lung or airway tissue. The tumor must be located by radial EBUS and a guide sheath placed prior to cryoablation. ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany): See BCI description. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lira Gutierrez | NYU Langone Health | 212-263-6181 | Lira.Gutierrez@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2023 | Apr 3, 2025 | Prot_SAP_000.pdf |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Percentage of Patients Who Experience Bleeding Complications | Posted | Number | Percentage of participants | Up to Day 7 Post-BCI |
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| Primary | Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy | Posted | Number | Percentage of participants | Up to Day 7 Post-BCI |
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| Primary | Length of Time to Perform BCI | Posted | Median | Inter-Quartile Range | Seconds | Day 0 |
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| Primary | Length of Fluoroscopy Exposure During BCI | Posted | Median | Inter-Quartile Range | Seconds | Day 0 |
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| Primary | Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure | 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. | Posted | Number | Percentage of participants | Up to Day 7 Post-BCI |
|
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| Secondary | Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers | 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. | Posted | Number | Percentage of participants | Up to Day 14 Post-BCI |
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| 3 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
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