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

March 26, 2024 updated by: NYU Langone Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Leopoldo Segal, MD, MSc
        • Contact:
          • N

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Leopoldo N Segal, MD, MSc, New York Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-01845

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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