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

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NYU Langone Health

Status

Enrolling

Conditions

Lung Cancer

Treatments

Other: Research Procedures
Other: Bronchoscopy

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04063501
18-01845

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Advanced stage unresectable Non-Small Cell Lung Cancer
Description:
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)
Treatment:
Other: Research Procedures
Other: Bronchoscopy

Trial contacts and locations

1

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Central trial contact

Rosemary Schluger; Lira Gutierrez

Data sourced from clinicaltrials.gov

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