Early Phase 1 Completed N=21 Treatment

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

Source: ClinicalTrials.gov NCT04049474 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2025

Primary outcomePrimary: Percentage of Successful Performances Among Patients in Whom BCI is Attempted — 100 Percentage of participants

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.

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.