Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bronchoscopy, Research Procedures.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Bronchoscopy
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways - Other Research Procedures
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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: 3 Years]
- Microbiota signatures in lower and upper airways [Time frame: 3 Years]
- Microbiota signatures in stool [Time frame: 3 Years]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT04063501 · 18-01845