Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
NCT ID: NCT04636775
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
46 participants
OBSERVATIONAL
2020-07-29
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Immunotherapy naïve NSCLC patients
Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade
Microbiome
Nasal and buccal swabs, and stool sample, as well as the extracted DNAs
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Microbiome
Nasal and buccal swabs, and stool sample, as well as the extracted DNAs
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Must have a target lesion to evaluate treatment response
* Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients
* Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1
Exclusion Criteria
* Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement
* Not English-speaking
* Patients that are pregnant
* Prisoners
* Students and employees
* Psychiatric illness/social situations that would limit compliance with study requirements
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jun Zhang, MD, PhD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jun Zhang, MD, PhD
Associate Professor; Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jun Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Kansas Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States
The University of Kansas Medical Center
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
KUCC Navigator
Role: primary
KUCC Navigation
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.
Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT-2020-MIP-NSCLC
Identifier Type: -
Identifier Source: org_study_id