Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
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.
Checked against the public recordLast updated Dec 2, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Not specified
- Study type
- Observational
- Phase
- Not applicable
- Sponsor
- NYU Langone Health
- Interventions being studied
- Other: Bronchoscopy; Other: Research Procedures
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- NYU Langone HealthNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 2, 2025. Always confirm current availability with the study team.