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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04063501
Collaborator
National Cancer Institute (NCI) (NIH)
80
Enrollment
1
Location
42
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Bronchoscopy
  • Other: Research Procedures

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Actual Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [3 Years]

    over ≥ 1-year follow-up

  2. Microbiota signatures in lower and upper airways [3 Years]

  3. Microbiota signatures in stool [3 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04063501
Other Study ID Numbers:
  • 18-01845
First Posted:
Aug 21, 2019
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Jun 30, 2022