TUMORIN: Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

Sponsor
Jun Zhang, MD, PhD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05332925
Collaborator
Nilogen Oncosystems (Industry)
25
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Feasibility of establishing 3D ex-vivo tumoroid model [2 years]

    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.

Secondary Outcome Measures

  1. Correlation of response in ex vivo tumoroids with clinical objective response [2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Jun Zhang, MD, PhD
  • Nilogen Oncosystems

Investigators

  • Principal Investigator: Jun Zhang, MD, PhD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jun Zhang, MD, PhD, Associate Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT05332925
Other Study ID Numbers:
  • IIT-2021-Tumorin
First Posted:
Apr 18, 2022
Last Update Posted:
Apr 22, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jun Zhang, MD, PhD, Associate Professor, University of Kansas Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 22, 2022