NCT04049474CompletedEarly phase 1
Bronchoscopic Cryo-Immunotherapy of Lung Cancer
Source: ClinicalTrials.gov · Last updated 24 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 6 Aug 2019
- Start date
- 15 Feb 2020
- Primary completion date
- 9 Apr 2024
- Lead sponsor
- NYU Langone Health
- Diseases
- Lung cancer
- NCT number
- NCT04049474
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 21
- From 15 Feb 2020 to the primary completion date, 9 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy.
Other illness
- Bleeding diathesis
Lab values
- 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)
Other
- Pregnancy
- Contraindication to bronchoscopy
Who the study is looking for
- 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
Age in the registry: 22 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.