NCT04063501Recruiting
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
NYU Langone Health
Start Date
2/9/2021
Completion Date
2/1/2027
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 Criteria
Age Range: 18 years to 100 years
Inclusion Criteria:
* 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 Criteria:
* 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
OTHER
Bronchoscopy
OTHER
Research Procedures
Conditions
Lung Cancer
Locations
NYU Langone Health
New York, New York 10016
United States