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

NCT04063501 | Recruiting

• 1 other identifier: 18-01845
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Progression-free survival (PFS)

  over ≥ 1-year follow-up

  3 Years

• Microbiota signatures in lower and upper airways

  3 Years

• Microbiota signatures in stool

  3 Years

Study Arms (1)

Advanced stage unresectable Non-Small Cell Lung Cancer

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)

Other: Bronchoscopy; Other: Research Procedures

Interventions

Bronchoscopy OTHER

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

Advanced stage unresectable Non-Small Cell Lung Cancer

Research Procedures OTHER

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.

Advanced stage unresectable Non-Small Cell Lung Cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Bacterial DNA will be extracted using an ion exchange column (Qiagen). Microbial DNA samples will potentially be further analyzed for relationships with underlying pathologies as well as to characterize in detail the genetic pool and genetic interactions..

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Leopoldo N Segal, MD, MSc

  New York Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lira Gutierrez

CONTACT

212-263-6181; Lira.Gutierrez@nyulangone.org

Rosemary Schluger

CONTACT

Rosemary.Schluger@nyulangone.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: February 9, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-12

Locations

US (1)