RecruitingObservational

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

NCT ID: NCT04063501Sponsor: NYU Langone HealthLast updated: 2025-12-02

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.

Arms & interventions

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

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

Eligibility criteria

Sex: AllAge: 18 Years to 100 YearsHealthy 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

Study locations (1)

NYU Langone Health

New York, New York, 10016

Recruiting

N · Contact

Leopoldo Segal, MD, MSc · Principal Investigator