Observational Study on Immunotherapy for Lung Cancer

This observational study is looking at how the body's natural defenses (immune system) and the tiny living organisms (microbiota) in your airways and gut might affect how well immunotherapy works for advanced non-small cell lung cancer. Researchers will collect samples like blood, stool, and from your airways to see if certain patterns in these samples can predict how you respond to PD-1 blockade treatment. You may be able to join if you have advanced non-small cell lung cancer and are starting PD-1 blockade treatment, either alone or with chemotherapy. The study will look at how long you live without your cancer getting worse (progression-free survival) and changes in your microbiota over three years. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 48 participants. It will collect samples and information over time to understand how different factors relate to treatment outcomes.
What's involved
You would have an electrocardiogram, blood work, X-ray, and lung function tests. You would also provide a stool collection kit and undergo a research bronchoscopy to sample your airways.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years to assess progression-free survival and changes in microbiota signatures.

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NCT04063501

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

Recruiting
Not specifiedAges 18+Observational
NYU Langone Health
~48 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:BronchoscopyResearch Procedures

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS)
Measured over 3 Years
+2 more outcomes measured
Lung Cancer
1 sites across 1 states
New York1
  • Leopoldo N Segal, MD, MSc · PRINCIPAL_INVESTIGATOR · New York Langone Health

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Eligibility criteria

Inclusion

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

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
  • Progression-free survival (PFS)3 Years

    over ≥ 1-year follow-up

  • Microbiota signatures in lower and upper airways3 Years
  • Microbiota signatures in stool3 Years