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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Lung Cancer

NCT04063501

NYU Langone Health

26 January 2024

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