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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05332925
Other study ID # IIT-2021-Tumorin
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 21, 2022
Est. completion date February 2027

Study information

Verified date February 2024
Source University of Kansas Medical Center
Contact Darlene Kocher
Phone 9135887132
Email dkocher@kumc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To test whether it is feasible to perform the 3D-EX functional predictive response bioassay in the context of patients with advanced/metastatic NSCLC receiving immune checkpoint inhibitors in the standard of care clinical setting.


Description:

Non-small cell lung cancer (NSCLC), which accounts for approximately 85% of all lung cancer cases, remains the leading cause of cancer death worldwide. Immunotherapy such as using immune checkpoint inhibitors (ICIs) to target the programmed death-1 and its ligand (PD-1/L1) has revolutionized our management of this deadly disease. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 25
Est. completion date February 2027
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria: - Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent - 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: - Incarcerated - Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

Study Design


Intervention

Drug:
Standard of care immune checkpoint inhbitors
This is NOT an interventional study.

Locations

Country Name City State
United States The University of Kansas Cancer Center (KUCC) Fairway Kansas
United States The University of Kansas Cancer Center, Westwood Campus Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
Jun Zhang, MD, PhD Nilogen Oncosystems

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility of establishing 3D ex-vivo tumoroid model Twenty-five patients will be enrolled. The bioassay will be considered to be feasible if the 3D Ex-Vivo assay results are obtained on at least 20 patients. 2 years
Secondary Correlation of response in ex vivo tumoroids with clinical objective response To test whether the 3D-EX functional response bioassay can predict tumor response (using RECIST v1.1) in patients with advanced/metastatic NSCLC, receiving treatment with immune checkpoint inhibitors, in a standard clinical setting. 2 years
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