Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT04063501

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy

Research Procedures

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT04063501

Start date

Feb 9, 2021

Status verified date

Dec, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Interventions

Bronchoscopy

The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways

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.

Primary outcome measure

  • Progression-free survival (PFS) [ Time Frame: 3 Years ]
  • Microbiota signatures in lower and upper airways [ Time Frame: 3 Years ]
  • Microbiota signatures in stool [ Time Frame: 3 Years ]

Central Contacts and Locations

Central contacts

Lira Gutierrez

212-263-6181Lira.Gutierrez@nyulangone.org

Rosemary Schluger

Rosemary.Schluger@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Leopoldo Segal, MD, MSc

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 2, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-02.