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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04063501

Enrollment

Registered

2019-08-21

Start date

2021-02-09

Completion date

2027-02-28

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

OTHERBronchoscopy

The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways

OTHERResearch Procedures

electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression-free survival (PFS)	3 Years	over ≥ 1-year follow-up
Microbiota signatures in lower and upper airways	3 Years	—
Microbiota signatures in stool	3 Years	—

Countries

United States

Contacts

Primary ContactLira Gutierrez

Lira.Gutierrez@nyulangone.org212-263-6181

Backup ContactRosemary Schluger

Rosemary.Schluger@nyulangone.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026