An observational study in Lung Cancer, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by NYU Langone Health · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 48 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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 · Other: Research Procedures
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
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.
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 is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NYU Langone Health