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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT04063501
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Bronchoscopy — OTHER
    The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
  • Research Procedures — OTHER
    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 Details

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.

Key Dates

Start date
Feb 9, 2021
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: Advanced stage unresectable Non-Small Cell Lung Cancer
    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 Measure

Progression-free survival (PFS) [ Time Frame: 3 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
N
Leopoldo Segal, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
NYU Langone Health· New York, NY

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