NCT04063501

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

• Lung Cancer

Interventions

Type	Name	Description
OTHER	Bronchoscopy	The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
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.

Timeline

• Start date: 2021-02-09
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2019-08-21
• Last updated: 2025-12-02

Locations

1 site across 1 country: United States