Evaluating Microbial and Host Signatures in Lung Cancer Immunotherapy
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
This study is trying to see if the germs in the lungs and gut, along with immune responses in the blood, can help predict how well lung cancer patients do on immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04063501 on ClinicalTrials.gov |
What this trial studies
This observational study will collect airway, stool, and blood samples from 80 patients with lung cancer who are receiving immunotherapy. The goal is to analyze microbial signatures in the airway and stool, as well as immune responses in the blood, to determine their association with treatment outcomes. Researchers will conduct longitudinal assessments to see if these microbial and host signatures can predict the patients' responses to immunotherapy, with follow-up sampling after 8 weeks of treatment to deepen the understanding of the mechanisms involved.
Who should consider this trial
Good fit: Ideal candidates are adults with advanced stage unresectable Non-Small Cell Lung Cancer who are eligible for PD-1 blockade treatment.
Not a fit: Patients with recent antibiotic, steroid, or chemotherapy treatments, or those with significant comorbidities such as brain metastasis or severe cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for lung cancer patients based on their microbiome and immune profiles.
How similar studies have performed: While the approach of evaluating microbiome impacts on immunotherapy is gaining interest, this specific longitudinal evaluation in lung cancer is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Leopoldo N Segal, MD, MSc — New York Langone Health
- Study coordinator: Lira Gutierrez
- Email: Lira.Gutierrez@nyulangone.org
- Phone: 212-263-6181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.