Recruiting

Immunotherapy Response

Sponsor:

Jun Zhang, MD, PhD

Code:

NCT05332925

Conditions

Lung Cancer

NSCLC

NSCLC Stage IV

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard of care immune checkpoint inhbitors

Study Details

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

Study ID

NCT05332925

Start date

Jul 21, 2022

Status verified date

Feb, 2024

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Interventions

Standard of care immune checkpoint inhbitors

This is NOT an interventional study.

Primary outcome measure

  • Feasibility of establishing 3D ex-vivo tumoroid model [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Darlene Kocher

9135887132dkocher@kumc.edu

Jonathon Barnette

9135887132jbarnette@kumc.edu

Locations

The University of Kansas Cancer Center (KUCC)

Recruiting

Fairway, Kansas, United States, 66205

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

Steve Williamson, MD

913-588-3808SWILLIAM@kumc.edu

The University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

More Information

Sponsor

Jun Zhang, MD, PhD

Last update posted

Feb 23, 2024

Last verified

Feb, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jun Zhang, MD, PhD on 2024-02-23.