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NCT04063501 | RECRUITING | Lung Cancer

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

NYU Langone Health

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 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.

Condition or disease

Lung Cancer

Intervention/treatment

Bronchoscopy

Research Procedures

Study Type : OBSERVATIONAL
Estimated Enrollment : 40 participants
Official Title : Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Actual Study Start Date : 2021-02-09
Estimated Primary Completion Date : 2026-12
Estimated Study Completion Date : 2027-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer

Location Details

NCT04063501

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

NYU Langone Health

New York, New York, United States, 10016