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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063501
• Other study ID #: 18-01845
• Status: Recruiting
• Start date: February 9, 2021
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Lira Gutierrez
• Phone: 212-263-6181
• Email: Lira.Gutierrez[@]nyulangone.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Bronchoscopy
The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	over = 1-year follow-up	3 Years
Primary	Microbiota signatures in lower and upper airways		3 Years
Primary	Microbiota signatures in stool		3 Years