RecruitingNCT04063501

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

Sponsor

NYU Langone Health

Enrollment

48 participants

Start Date

Feb 9, 2021

Study Type

OBSERVATIONAL

Conditions

Lung Cancer

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 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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how gut bacteria (the microbiome) and the immune system interact in patients with advanced lung cancer who are receiving immunotherapy. Researchers want to understand why immunotherapy works better for some patients than others, and whether gut bacteria play a role. **You may be eligible if...** - You are an adult with advanced non-small cell lung cancer (a type that cannot be surgically removed) - You are scheduled to receive an immunotherapy drug that targets PD-1 (a checkpoint inhibitor), either alone or with chemotherapy **You may NOT be eligible if...** - You have taken antibiotics, steroids, or chemotherapy within the past month - You have brain metastases (cancer that has spread to the brain) - Your lung function is significantly reduced (FEV1 below 50% predicted) - You have significant heart, kidney, liver, or blood clotting problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBronchoscopy

The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways

OTHERResearch 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.