TheranosticTrials.org

Clinical Trial · NCT07500285

Yittrium-90(Y-90) Fibroblast Activation Protein Inhibitor (FAPI) Therapy in Patients With Non-Small Cell Lung Cancer (Phase II)

Overview

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related mortality worldwide and accounts for approximately 80% of all lung cancer cases. Despite advances in chemotherapy, radiotherapy, and immunotherapy, the prognosis of patients with advanced-stage metastatic NSCLC remains poor, with limited therapeutic options after the development of treatment resistance. Fibroblast Activation Protein (FAP) is highly expressed in cancer-associated fibroblasts in a wide range of solid tumors and represents a promising target for tumor-specific theranostic approaches. Gallium-68-labeled FAPI (Ga-68 FAPI) PET/CT has recently demonstrated high sensitivity in imaging primary lung tumors and metastatic lesions. This Phase II study aims to evaluate the safety, feasibility, dosimetry, and therapeutic efficacy of Yttrium-90-labeled FAPI (Y-90 FAPI) radionuclide therapy in patients with chemotherapy-resistant metastatic NSCLC showing significant FAP expression on Ga-68 FAPI PET/CT imaging.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Merve N Acar Tayyar (CONTACT)

nurmacar13@gmail.com

+905532079693

Muge O. Tamam, Professor (CONTACT)

mugetamam@yahoo.com

+90532402376

ClinicalTrials.gov

NCT07500285

Drug / Compound

FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

FAPI

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Disease progression or resistance after all standard approved therapies as determined by a multidisciplinary tumor board
  • Metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ga-68 FAPI PET/CT demonstrating increased tracer uptake in tumor lesions (SUVmax ≥10 in more than 50% of metastatic lesions)
  • Platelet count ≥50 × 10⁹/L
  • Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
  • Serum albumin ≥2.0 g/dL
  • Hemoglobin ≥8.0 g/dL

Exclusion

  • Diagnosis of small cell lung cancer