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

NYU Langone Health

Status: Enrolling

Conditions: Lung Cancer

Treatments: Other: Research Procedures; Other: Bronchoscopy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04063501

18-01845

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Advanced stage unresectable Non-Small Cell Lung Cancer

Description:

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)

Treatment:

Other: Research Procedures

Other: Bronchoscopy