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

Phase

N/A

Condition

Cancer

Lung Cancer

Non-small Cell Lung Cancer

Treatment

Research Procedures

Bronchoscopy

Clinical Study ID

NCT04063501

18-01845

Ages 18-100
All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell LungCancer and indication for PD-1 blockade treatment (either as monotherapy or combinedwith chemotherapy)

Exclusion

Exclusion Criteria:

Antibiotic, steroid, or chemotherapy received within the prior month since these arepossible confounders that may impact the microbiome and the host immunity.
Brain metastasis (as evaluated by MRI obtained as part of standard of care stagingevaluation)
FEV1<50% predicted
Cardiovascular disease (defined as abnormal EKG, known or suspected coronary arterydisease or congestive heart failure)
Renal disease
Coagulopathy
Liver disease

Study Design