Bronchoscopic Cryo-Immunotherapy for the Treatment of Advanced Unresectable Non-small Cell Lung Cancer

Status: closed to accrual

This phase I trial studies the side effects and best dose of bronchoscopic cryo-immunotherapy in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced) and cannot be removed by surgery (unresectable). Bronchoscopic cryo-immunotherapy (BCI) involves “cryoablating” part of the lung tumor during bronchoscopy. BCI applies freezing temperatures to the lung tumor, which may cause tumor cell death and injury. The purpose of this study is to evaluate the safety of BCI and the ability of BCI to cause the immune system to attack the lung tumor.

Inclusion Criteria

Biopsy-proven, advanced, inoperable non-small cell lung cancer (stages IIIA/B/C and IVA/B based on the 8th edition TNM staging guidelines) or suspected inoperable non-small cell lung cancer (stage as defined above) who may undergo on-site pathology review of tissue specimen obtained at time of diagnostic and staging bronchoscopy * If on-site pathology review is not feasible or is unable to confirm the diagnosis of non-small cell lung cancer, patients with high-risk features for the diagnosis of non-small cancer including past or current cigarette smoking, history of chronic obstructive pulmonary disease (COPD), spiculated lesion with bronchus sign on chest computed tomography (CT), presence of mediastinal/hilar adenopathy or evidence of distant metastatic disease on chest CT scan or positron emission tomography (PET) CT scan may be included
Pre-procedure chest CT scan with the presence of an airway path leading directly to the peripheral lung tumor (also known as a “bronchus sign”), and the peripheral lung tumor will need to be visualized by radial endobronchial ultrasound at time of bronchoscopy
Undergoing bronchoscopy for diagnostic and/or palliative purpose unrelated to this study
Age of 22 years or older
Ability to provide informed consent
Concomitant chemotherapy, immunotherapy, and/or radiation therapy are allowed
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2

Exclusion Criteria

Pregnancy (negative pregnancy test required for women of child-bearing age)
Currently on a platelet inhibitor (such as clopidogrel) other than aspirin or non-steroidal anti-inflammatory drugs (NSAIDS), or on a blood thinner (such as heparin, enoxaparin, or a novel oral anticoagulant), which is unable to be held for planned bronchoscopy
International normalized ratio (INR) >= 1.5 (after correction and only if checked pre-operatively based on clinical indication)
Platelets =< 100,000 (post correction)
Absence of tissue diagnosis of non-small cell lung cancer either prior to procedure or during on-site pathology review at time of bronchoscopy in patients without the above specified high-risk features
Absolute contraindication to bronchoscopy

PRIMARY OBJECTIVES:

I. Demonstrate feasibility of bronchoscopic cryo-immunotherapy (BCI).

II. Determine the safety and maximum tolerated dose (MTD) of BCI.

SECONDARY OBJECTIVES:

I. Pre- and post-BCI peripheral blood analysis.

II. Investigate BCI association with PD-1 phenotype of effector T cells in non-small cell lung cancer (NSCLC).

OUTLINE: This is a dose-escalation study.

Patients undergo BCI for up to 20 minutes during standard of care bronchoscopy.

After completion of study treatment, patients are followed up at 7 and 14 days.

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Bronchoscopic Cryo-Immunotherapy for the Treatment of Advanced Unresectable Non-small Cell Lung Cancer

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