NCT05332925

Using Ex Vivo Tumoroids To Predict Immunotherapy Response In NSCLC

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 25 (estimated)
• Sponsor: Jun Zhang, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Lung Cancer
• NSCLC
• NSCLC Stage IV

Interventions

Type	Name	Description
DRUG	Standard of care immune checkpoint inhbitors	This is NOT an interventional study.

Timeline

• Start date: 2022-07-21
• Primary completion: 2026-01-01
• Completion: 2027-02-01
• First posted: 2022-04-18
• Last updated: 2024-02-23

Locations

2 sites across 1 country: United States