Home › Lung Cancer › NCT04063501

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

Who can join

Ages 18 to 100 · All sexes

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

About the study

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.

What is being tested

• Bronchoscopy (other)
• Research Procedures (other)

Sponsor: NYU Langone Health · Participants: 48 · Started: Feb 9, 2021

Contact the study team

• Lira Gutierrez · Phone: 212-263-6181

Official record on ClinicalTrials.gov — NCT04063501

Locations in the U.S.

Conditions

• Lung Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.