What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, cryotherapy, and chemotherapy. Immunotherapy can cause autoimmune-related adverse events such as dermatologic, gastrointestinal, and endocrinologic side effects. Cryotherapy may lead to local tissue damage and inflammation. Chemotherapy is associated with side effects like neuropathy, hearing loss, and neurocognitive changes. Combining these treatments, as in bronchoscopic cryo-immunotherapy, aims to enhance anti-tumor immune responses but may also compound these side effects.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 antibody, is approved for use in combination with chemotherapy for advanced nonsquamous NSCLC. Atezolizumab, another immunotherapy drug, has been approved in combination with bevacizumab and chemotherapy (ABCP regimen) for patients without EGFR mutations or ALK translocations, as demonstrated in the IMpower 150 trial. Nivolumab, an anti-PD-1 antibody, is approved for use after progression on platinum-based chemotherapy. These treatments aim to induce anti-tumor immune responses, similar to the goal of Bronchoscopic Cryo-Immunotherapy (BCI).

What other types of research exist?

Promising novel alternatives to Bronchoscopic Cryo-Immunotherapy for NSCLC patients include immune checkpoint inhibitors like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways. Combination therapies, such as nivolumab plus ipilimumab or nivolumab with VEGFR inhibitors like cabozantinib, are also being explored and have shown potential in clinical trials. These treatments aim to enhance anti-tumor immune responses and have demonstrated efficacy in advanced NSCLC.

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Cryo-Immunotherapy

Cryo-Immunotherapy for Lung Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, works by enhancing the body's immune system to recognize and attack cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, while targeted therapy focuses on specific genetic mutations within cancer cells to inhibit their growth. Bronchoscopic Cryo-Immunotherapy (BCI) combines cryotherapy, which freezes and destroys tumor cells, with the goal of inducing an anti-tumor immune response. This approach is significant for NSCLC patients as it not only directly targets the tumor but also aims to stimulate the immune system to fight cancer more effectively, potentially leading to better outcomes and prolonged survival.

Phase < 1

Waitlist Available

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

Must not have

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

Bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

Summary

This trial is testing a new treatment that freezes lung tumors in patients with advanced non-small cell lung cancer. The goal is to kill the cancer cells and help the immune system fight the disease. Blood samples will be taken at different times to see if it works.

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.

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.

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

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am taking a blood thinner or platelet inhibitor that can't be stopped for a lung exam.

Select...

I have a bleeding disorder.

Select...

I have not been diagnosed with non-small cell lung cancer through tissue diagnosis.

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I cannot undergo bronchoscopy due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility

Safety

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 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, works by enhancing the body's immune system to recognize and attack cancer cells. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, while targeted therapy focuses on specific genetic mutations within cancer cells to inhibit their growth. Bronchoscopic Cryo-Immunotherapy (BCI) combines cryotherapy, which freezes and destroys tumor cells, with the goal of inducing an anti-tumor immune response. This approach is significant for NSCLC patients as it not only directly targets the tumor but also aims to stimulate the immune system to fight cancer more effectively, potentially leading to better outcomes and prolonged survival.

Immunotherapy for Non-Small Cell Lung Cancer - Finally a Hint of Hope.Cryosurgery for lung cancer.