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

Description

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

Lung Cancer

Study Overview

Study Details

Study 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.

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

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

Condition
Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Leopoldo N Segal, MD, MSc, PRINCIPAL_INVESTIGATOR, New York Langone Health

Study Record Dates

2026-02