Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Lung Cancer Clinical Trial

— TUMORIN  

Official title:

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332925
• Other study ID #: IIT-2021-Tumorin
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• NSCLC
• NSCLC Stage IV

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