Bronchoscopy With Bronchoalveolar Lavage in Identifying Biomarkers of Response to Immune Checkpoint Inhibitors in Patients With Non-small Cell or Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To discover predictive immune biomarkers of response to immune checkpoint inhibitor
therapy in individuals with primary lung cancer.

SECONDARY OBJECTIVES:

I. To determine biomarkers that may be predictive of treatment related adverse events,
specifically pneumonitis.

II. To further elucidate lung immunologic microenvironment by performing single cell analysis
in addition to mass cytometry (Cytof) on cells of bronchoalveolar lavage.

OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes.

After completion of study, patients are followed up at 3, 6, 12, and 24 months.

Inclusion Criteria:

- Confirmed diagnosis of non-small cell lung cancer (NSCLC) or small cell lung cancer
(SCLC)

- Candidate to undergo immune checkpoint inhibitor (ICI) therapy for SCLC or NSCLC (ICI
as any line of chemotherapy is acceptable) as deemed by individual's treating
oncologist

- Enrollment into this study may occur in tandem with other clinical therapeutics trials
occurring at Vanderbilt University Medical Center (VUMC) as long as this trial does
not violate protocol or inclusion criteria of that study

Exclusion Criteria:

- Coagulopathy with international normalized ratio (INR) > 2.0 or

- Coagulopathy with platelets (Plt) < 10 k

- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
antibody (including ipilimumab or any other antibody or drug specifically targeting
T-cell co-stimulation or checkpoint pathways)

- Subjects with an active or recent history of a known or suspected autoimmune disease
or recent history of a syndrome that required systemic
corticosteroids/immunosuppressive medications

- Respiratory failure requiring greater than 6 Lpm supplemental oxygen (O2) by nasal
cannula or mechanical ventilation within the past six weeks

- Inability to perform informed consent due to any medical or psychiatric condition