RecruitingNCT04063501

Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Sponsor

NYU Langone Health

Enrollment

48 participants

Start Date

Feb 9, 2021

Study Type

OBSERVATIONAL

Conditions

Lung Cancer

Summary

This study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria1

Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)

Exclusion Criteria7

Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
FEV1\<50% predicted
Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
Renal disease
Coagulopathy
Liver disease

Interventions

OTHERBronchoscopy

The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways

OTHERResearch Procedures

electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.