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NCT Number: NCT04063501

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

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.

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Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Leopoldo Segal, MD, MSc

PRINCIPAL_INVESTIGATOR

N

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bronchoscopy

Other

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

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.

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: 3 Years

    over ≥ 1-year follow-up

  2. Microbiota signatures in lower and upper airways

    Time frame: 3 Years

  3. Microbiota signatures in stool

    Time frame: 3 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Lira Gutierrez

CONTACT

[email protected]

212-263-6181

Rosemary Schluger

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Aug 21, 2019
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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