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

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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Lung Cancer; NSCLC Stage IV
• Intervention / Treatment: Drug: Standard of care immune checkpoint inhbitors

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Darlene Kocher; Phone Number: 9135887132; Email: dkocher@kumc.edu
• Study Contact Backup: Name: Jonathon Barnette; Phone Number: 9135887132; Email: jbarnette@kumc.edu

Study Locations

• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • The University of Kansas Cancer Center (KUCC)
      • Contact: Steve Williamson, MD; Phone Number: 913-588-3808; Email: SWILLIAM@kumc.edu
      • Contact: Clinical Trials Nurse Navigator; Phone Number: 913-945-7552; Email: ctnursenav@kumc.edu
    • Kansas City, Kansas, United States, 66205
      • Recruiting
      • The University of Kansas Cancer Center, Westwood Campus
      • Contact: Clinical Trials Nurse Navigator; Phone Number: 913-945-7552; Email: ctnursenav@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Advanced/metastatic NSCLC patients who are immunotherapy naïve and ready to receive immune checkpoint inhibitors as standard--of-care treatment.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jun Zhang, MD, PhD
• Collaborators: Nilogen Oncosystems
• Investigators: Principal Investigator: Jun Zhang, MD, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Anti-PD-1; 3D culture; Anti-CTLA-4; Organoids; Tumoroids; Immune check point inhibitor; Ex vivo model
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IIT-2021-Tumorin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No