Clinical trial · Observational
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC
Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC (TUMORIN)
NCT05332925CI-TRIAL-00074316TUMORINrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard of care immune checkpoint inhbitors | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility of establishing 3D ex-vivo tumoroid model
- timeFrame
- 2 years
- description
- 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 outcomes (1)
- measure
- Correlation of response in ex vivo tumoroids with clinical objective response
- timeFrame
- 2 years
- description
- 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
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 110 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.