Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

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Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

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Hematinics

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Liver Extracts

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)

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

Bronchoscopy

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.

Research Procedures

Lira Gutierrez

Rosemary Schluger

Leopoldo Segal, MD, MSc

Leopoldo N Segal, MD, MSc

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.

Bacterial DNA will be extracted using an ion exchange column (Qiagen). Microbial DNA samples will potentially be further analyzed for relationships with underlying pathologies as well as to characterize in detail the genetic pool and genetic interactions..

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

National Cancer Institute (NCI)

NYU Langone Health

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer	NCT04063501	Lung Cancer	Bronchoscopy Research Proced...	18 Years - 100 Years	NYU Langone Health
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer	NCT04063501	Lung Cancer	Bronchoscopy Research Proced...	18 Years - 100 Years	NYU Langone Health
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer	NCT04063501	Lung Cancer	Bronchoscopy Research Proced...	18 Years - 100 Years	NYU Langone Health

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