← Back to Search

Cryo-Immunotherapy

Cryo-Immunotherapy for Lung Cancer

Q: Is the age cut-off for this research 55 or below?

As per the criteria for entry, eligible participants must be between 22 and 80 years old.

Q: Are there any limitations to the number of participants accepted into this research study?

Affirmative. The information accessible on clinicaltrials.gov elucidates that this research effort, which first went live on February 15th 2020, is currently recruiting participants. There are 24 roles to be filled across a single site location.

Q: Are there any remaining slots available in this experiment?

According to the records held on clinicaltrials.gov, this research is presently in search of participants. The initial posting dates back to February 15th 2020 and most recently was updated June 24th 2022.

Q: Am I qualified to take part in this research?

This trial is currently enrolling 24 participants between the ages of 22 and 80, who are suffering from lung cancer. In order to be considered a possible candidate for this study, one must possess an identifiable bronchus or airway path leading directly to their peripheral tumor as evidenced by pre-procedure chest CT scans, have documented non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> either prior to procedure or during bronchoscopy onsite pathology assessment (before proceeding with planned BCI), demonstrate ECOG performance status less than or equal 2, exhibit comprehension of informed consent process, and may be receiving concomitant chemotherapy; <a href="https://www.withpower.com/clinical-trials/immunotherapy">immunotherapy</a>; radiation therapy treatments

Phase < 1

Recruiting

Led By Daniel Sterman, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status less than or equal to 2

Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days

Awards & highlights

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?

This trial is for adults with advanced non-small cell lung cancer who have a tumor accessible by airway on CT scan, can give consent, and may be undergoing other cancer treatments. They must not be pregnant, have bleeding issues or low platelets, take certain blood thinners that can't be stopped for the procedure, or lack a confirmed diagnosis.Check my eligibility

What is being tested?

The study tests bronchoscopic cryo-immunotherapy (BCI) using ERBOKRYO® CA to freeze lung tumors and potentially trigger immune responses against the cancer. It's being tested in 15 patients to see if it's safe and feasible.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks might include discomfort at the treatment site, potential damage to surrounding tissues from freezing temperatures used in BCI therapy, and general anesthesia-related complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am scheduled for a bronchoscopy for reasons not related to this study.

Select...

My lung cancer type has been confirmed as non-small cell.

Select...

My lung cancer is advanced and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility

Safety

Secondary outcome measures

Ability of radial endobronchial ultrasound to identify peripheral lung tumor

Correlation of BAL PD-1 phenotype with peripheral blood

Length of fluoroscopy exposure during BCI

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bronchoscopic Cryo-Immunotherapy (BCI)Experimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,702 Total Patients Enrolled

Daniel Sterman, MDPrincipal InvestigatorNew York Langone Health

1 Previous Clinical Trials

53 Total Patients Enrolled

Media Library

Bronchoscopic Cryo-Immunotherapy (Cryo-Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04049474 — Phase < 1

Non-Small Cell Lung Cancer Research Study Groups: Bronchoscopic Cryo-Immunotherapy (BCI)

Non-Small Cell Lung Cancer Clinical Trial 2023: Bronchoscopic Cryo-Immunotherapy Highlights & Side Effects. Trial Name: NCT04049474 — Phase < 1

Bronchoscopic Cryo-Immunotherapy (Cryo-Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04049474 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cut-off for this research 55 or below?

"As per the criteria for entry, eligible participants must be between 22 and 80 years old."

Answered by AI

Are there any limitations to the number of participants accepted into this research study?

"Affirmative. The information accessible on clinicaltrials.gov elucidates that this research effort, which first went live on February 15th 2020, is currently recruiting participants. There are 24 roles to be filled across a single site location."

Answered by AI

Are there any remaining slots available in this experiment?

"According to the records held on clinicaltrials.gov, this research is presently in search of participants. The initial posting dates back to February 15th 2020 and most recently was updated June 24th 2022."

Answered by AI

Am I qualified to take part in this research?

"This trial is currently enrolling 24 participants between the ages of 22 and 80, who are suffering from lung cancer. In order to be considered a possible candidate for this study, one must possess an identifiable bronchus or airway path leading directly to their peripheral tumor as evidenced by pre-procedure chest CT scans, have documented non-small cell lung cancer either prior to procedure or during bronchoscopy onsite pathology assessment (before proceeding with planned BCI), demonstrate ECOG performance status less than or equal 2, exhibit comprehension of informed consent process, and may be receiving concomitant chemotherapy; immunotherapy; radiation therapy treatments"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bronchoscopic Cryo-Immunotherapy of Lung Cancer

2020. "Bronchoscopic Cryo-Immunotherapy of Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04049474.

All > Lung Cancer Philadelphia