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

NCT04063501 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2025-12-02

No results posted yet for this 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.

Conditions

Interventions

OTHER

Research 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.

OTHER

Bronchoscopy

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

Sponsors & Collaborators

Principal Investigators

  • Leopoldo N Segal, MD, MSc · New York Langone Health

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063501 on ClinicalTrials.gov