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

Recruiting

• Conditions: Lung Cancer
• Interventions: Other: Bronchoscopy; Other: Research Procedures

• Registration Number: NCT04063501
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Study Start: 2021-02-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced stage unresectable Non-Small Cell Lung Cancer	Research Procedures	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)
Advanced stage unresectable Non-Small Cell Lung Cancer	Bronchoscopy	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States