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RecruitingNot applicableNCT04063501
Official study title

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

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBronchoscopy and Research Procedures

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 2, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?NYU Langone Health

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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)

Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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