NCT04063501Recruiting
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 48 (estimated)
- First submitted
- 19 Aug 2019
- Start date
- 9 Feb 2021
- Primary completion date
- Dec 2027
- Lead sponsor
- NYU Langone Health
- Diseases
- Lung cancer
- NCT number
- NCT04063501
What you commit to
- Study type: Observational
- Planned participants: 48
- From 9 Feb 2021 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity.
Other illness
- Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure)
- Renal disease
- Liver disease
Other
- Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation)
- FEV1\<50% predicted
- Coagulopathy
Who the study is looking for
- 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)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.