Lung CancerNCT04063501
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bronchoscopy and Research Procedures
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rosemary Schluger contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
N
Leopoldo Segal, MD, MSc
About this study
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
- Being tested
- Bronchoscopy, Research Procedures
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyOther
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
Research ProceduresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Bronchoscopy; Other: Research Procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
over ≥ 1-year follow-up
Measured: 3 Years
Microbiota signatures in lower and upper airways
Measured: 3 Years
Microbiota signatures in stool
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start9 Feb 2021
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Leopoldo N Segal, MD, MSc, Principal investigator, New York Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063501
- Sponsor's protocol ID
- 18-01845
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2019
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
- ClinicalTrials.gov ID
- NCT04063501
- Acronym / sponsor ID
- 18-01845
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced stage unresectable Non-Small Cell Lung Cancer | – | Other: Bronchoscopy, Other: Research ProceduresAdult 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyThe patient will then return within a week for a research bronchoscopy to sample the upper and lower airways | Other | Advanced stage unresectable Non-Small Cell Lung Cancer |
| Research Procedureselectrocardiogram, 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. | Other | Advanced stage unresectable Non-Small Cell Lung Cancer |
Primary outcome
Progression-free survival (PFS)
Time frame: 3 Years
over ≥ 1-year follow-up
Microbiota signatures in lower and upper airways
Time frame: 3 Years
Microbiota signatures in stool
Time frame: 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rosemary Schluger contact
Leopoldo N Segal, MD, MSc principal investigator
New York Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lira Gutierrez (212-263-6181, Lira.Gutierrez@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 3 Years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.