Clinical trial NCT04049474: Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Official title: Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Successful Performances Among Patients in Whom BCI is Attempted
timeFrame: Day 0 (Intraoperative)
measure: Percentage of Patients Who Experience Bleeding Complications
timeFrame: Up to Day 7 Post-BCI
measure: Percentage of Participants Who Experience Pneumothorax Requiring Tube Thoracostomy
timeFrame: Up to Day 7 Post-BCI
measure: Length of Time to Perform BCI
timeFrame: Day 0
measure: Length of Fluoroscopy Exposure During BCI
timeFrame: Day 0
measure: Percentage of Participants Who Experience Grade 4-5 Adverse Events Potentially Related to Procedure
timeFrame: Up to Day 7 Post-BCI
Secondary outcomes:
measure: Percentage of Patients With Peripheral Blood CD8+ T Cells Displaying at Least One Combination of Hypothesized Markers
timeFrame: Up to Day 14 Post-BCI
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Health
name: Daniel Sterman, MD
role: PRINCIPAL_INVESTIGATOR
References: