Status:
RECRUITING
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18-100 years
Brief 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 associate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04063501
Start Date
February 9 2021
End Date
February 1 2027
Last Update
December 2 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016