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.
Age ≥18 years
Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
Metastatic disease
Prior staging with F-18 FDG PET/CT
Age <18 years
Diagnosis of small cell lung cancer
History of another active malignancy
Pregnancy or breastfeeding
Single group
Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)
DrugYttrium-90-labeled Fibroblast Activation Protein inhibitor (Y-90 FAPI) administered intravenously as targeted radionuclide therapy in patients with chemotherapy-resistant metastatic non-small cell lung cancer demonstrating significant FAP expression on Ga-68 FAPI PET/CT imaging.
1. Safety and Tolerability
Safety and Tolerability Measure Description: Incidence and severity of treatment-related adverse events following Y-90 FAPI therapy, graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Objective Tumor Response
Proportion of patients achieving complete or partial metabolic response on FDG PET/CT according to PERCIST criteria.
Dosimetry
Absorbed radiation dose to tumor lesions and critical organs calculated using post-therapy SPECT/CT imaging.
Disease Control Rate
Proportion of patients achieving complete response, partial response, or stable disease after Y-90 FAPI therapy.
Progression-Free Survival (PFS)
Time from Y-90 FAPI administration to documented disease progression or death from any cause.
Overall Survival (OS)
Time from Y-90 FAPI therapy to death from any cause.
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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead sponsor
Health Institutes of Turkey
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
