Actively Recruiting
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Led by NYU Langone Health · Updated on 2025-12-02
48
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
L
Lira Gutierrez
CONTACT
R
Rosemary Schluger
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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