Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

NCT05332925 | Recruiting

• 1 other identifier: IIT-2021-Tumorin
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Lung Cancer; NSCLC; NSCLC Stage IV

Keywords

Tumoroids; Organoids; Immunotherapy; Immune check point inhibitor; Anti-PD-1; Anti-CTLA-4; Ex vivo model; 3D culture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation of response in ex vivo tumoroids with clinical objective response

  2 years

Interventions

Standard of care immune checkpoint inhbitors DRUG

This is NOT an interventional study.

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Incarcerated
• Not competent to make medical decision, noncommunicative or noncompliant per investigator's judgement.

Sponsors & Collaborators

• Jun Zhang, MD, PhD: lead
• Nilogen Oncosystems: collaborator

Study Sites (2)

The University of Kansas Cancer Center (KUCC)

Fairway, Kansas, 66205, United States

RECRUITING

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3-4 cores fresh tissue using 20g or larger core biopsy

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Jun Zhang, MD, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Darlene Kocher

CONTACT

9135887132; dkocher@kumc.edu

Jonathon Barnette

CONTACT

9135887132; jbarnette@kumc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 18, 2022
• Study Start: July 21, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

US (2)