Advanced Non-small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DEVICEERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)
See BCI description.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure | 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. |
| Length of Time to Perform BCI | Day 0 | — |
| Length of Fluoroscopy Exposure During BCI | Day 0 | — |
| Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy | Up to Day 7 Post-BCI | — |
| Percentage of Successful Performances Among Patients in Whom BCI is Attempted | 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. |
| Percentage of Patients Who Experience Bleeding Complications | Up to Day 7 Post-BCI | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Bronchoscopic Cryo-Immunotherapy (BCI) |
|---|---|
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 21 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Length of Fluoroscopy Exposure During BCI
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Length of Fluoroscopy Exposure During BCI | 201 Seconds |
Primary
Length of Time to Perform BCI
Time frame: Day 0
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Length of Time to Perform BCI | 17 Seconds |
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.
Time frame: Up to Day 7 Post-BCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure | 0 Percentage of participants |
Primary
Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
Time frame: Up to Day 7 Post-BCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy | 0 Percentage of participants |
Primary
Percentage of Patients Who Experience Bleeding Complications
Time frame: Up to Day 7 Post-BCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Percentage of Patients Who Experience Bleeding Complications | 0 Percentage of participants |
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.
Time frame: Day 0 (Intraoperative)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Percentage of Successful Performances Among Patients in Whom BCI is Attempted | 100 Percentage of participants |
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.
Time frame: Up to Day 14 Post-BCI
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bronchoscopic Cryo-Immunotherapy (BCI) | Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers | 50 Percentage of participants |