No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Study type
Observational
Participants needed
48 (estimated)
Sponsor
NYU Langone Health · Other
Who this trial is looking for
This trial is looking for adults with advanced lung cancer who are starting immunotherapy treatment. Participants will donate samples of blood, stool, and airway fluids to help understand the relationship between their body’s immune response and the microbes in their bodies.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced stage unresectable Non-Small Cell Lung Cancer
I need PD-1 blockade treatment, either alone or with chemotherapy
You may not be able to join if
I have taken antibiotics, steroids, or chemotherapy in the last month
I have brain metastasis
My lung function is below 50% predicted
I have cardiovascular disease
I have renal disease
I have coagulopathy
I have liver disease
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 fre…
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.
Trial Locations
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Eligibility Criteria
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 mon…
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
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