Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
NCT ID: NCT05332925
Last Updated: 2024-02-23
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
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RECRUITING
25 participants
OBSERVATIONAL
2022-07-21
2027-02-28
Brief Summary
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Detailed Description
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However, a large proportion of patients do not derive benefit due to primary, adaptive or acquired resistance. Hence, better identifying this patient population, understanding the resistance mechanism and exploring novel combinations with current SOC immunotherapy are urgently needed to continue to benefit our NSCLC patients.
The investigators hypothesize that patient-derived immune cell containing ex-vivo tumoroids could serve these purposes. In this study, the investigators plan to develop such a 3D ex-vivo system utilizing fresh biopsied tissue from NSCLC patients. The investigators plan to prospectively evaluate the value of these ex-vivo tumoroids in immunotherapy naive advanced/metastatic NSCLC patients who will be receiving anti-PD-1/L1 (with or without anti-CTLA-4) per standard-of-care.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Standard of care immune checkpoint inhbitors
This is NOT an interventional study.
Eligibility Criteria
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Inclusion Criteria
* Patients with advanced/metastatic NSCLC
* Must be immunotherapy naive
* Males and females age ≥ 18 years
* ECOG Performance Status 0 - 2
* Measurable disease by RECIST 1.1
* Must have a lesion (either primary or metastatic lesion) that can be safely biopsied to have sufficient tissue (at minimum, 3-4 cores using 20g or larger core biopsy) to generate tumoroids
* Must have at least one target lesion to evaluate treatment response
* Will be receiving anti-PD-1/L1 with or without anti-CTLA-4 per standard of care Adequate organ function defined per standard of care in this setting.
* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception as required/recommended by each immune checkpoint inhibitor used in the setting of standard of care.
Exclusion Criteria
* Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.
18 Years
110 Years
ALL
No
Sponsors
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Nilogen Oncosystems
INDUSTRY
Jun Zhang, MD, PhD
OTHER
Responsible Party
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Jun Zhang, MD, PhD
Associate Professor
Principal Investigators
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Jun Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2021-Tumorin
Identifier Type: -
Identifier Source: org_study_id
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