Lung Cancer Clinical Trial

Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for 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.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Lung Cancer

Estimated Enrollment:

80

Study ID:

NCT04063501

Recruitment Status:

Recruiting

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States More Info
Ashley N Witzl
Contact
212-263-1208
[email protected]
Leopoldo Segal, MD, MSc
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

80

Study ID:

NCT04063501

Recruitment Status:

Recruiting

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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