A Phase 2 interventional study of Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) in Non-Small Cell Lung Cancer and Metastatic Lung Carcinoma, sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. Not yet recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization · Phase 2, Interventional, and Treatment
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.
Lung cancer remains the most common cause of cancer-related death globally, and non-small cell lung cancer (NSCLC) constitutes approximately 80% of all lung cancer cases. Patients with advanced or metastatic NSCLC have a particularly poor prognosis, with a 5-year survival rate of less than 10%, even among those who initially respond to systemic therapies. In patients with widespread metastatic disease, the addition of immune checkpoint inhibitors to chemotherapy and external beam radiotherapy provides only a limited survival benefit.
Fibroblast Activation Protein (FAP) is a cell surface protein expressed in up to 90% of cancer-associated fibroblasts and has emerged as a novel tumor-specific therapeutic target. Recent clinical studies have demonstrated that Ga-68 FAPI PET/CT is highly effective in visualizing primary NSCLC lesions as well as pleural, nodal, adrenal, and brain metastases.
Yttrium-90 (Y-90) is a beta-emitting radionuclide with a physical half-life of approximately 64 hours and favorable radiation characteristics for radionuclide therapy. Based on the high tumor uptake observed on Ga-68 FAPI PET/CT imaging, Y-90 FAPI is expected to selectively target FAP-expressing tumor lesions while minimizing radiation exposure to healthy tissues.
Although large-scale clinical trials investigating Y-90 FAPI therapy are currently lacking, limited case-based applications have been reported in other solid tumors, including breast cancer and osteosarcoma. This Phase II study aims to address this gap by systematically evaluating Y-90 FAPI therapy in patients with chemotherapy-resistant metastatic NSCLC.
Eligible patients will undergo Ga-68 FAPI PET/CT imaging prior to treatment. Patients demonstrating significant FAP expression in primary and metastatic tumor lesions will be selected for Y-90 FAPI radionuclide therapy. The radiolabeling of Y-90 FAPI will be performed under appropriate quality control conditions, including assessment of radiochemical purity and stability, prior to clinical administration.
Y-90 FAPI will be administered intravenously to selected patients. Patients will be followed with clinical assessments, laboratory tests, and radiological imaging. Post-therapy imaging and dosimetric evaluations will be performed using Single Photon Emission Computed Tomography/Computed Tomography (SPECT/CT) to assess organ and tumor radiation doses. Safety and tolerability will be monitored throughout the study, and adverse events will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
This study aims to establish a novel nuclear medicine-based theranostic treatment approach for patients with metastatic NSCLC who have exhausted standard therapeutic options and to evaluate the potential of Y-90 FAPI as a safe and effective targeted radionuclide therapy.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's planned enrollment of 10 is below the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
This single-arm study includes patients with histopathologically confirmed advanced non-small cell lung cancer (NSCLC) who are eligible for radioligand therapy. All enrolled participants will receive Yttrium-90-labeled FAPI (90Y-FAPI) administered intravenously according to the study protocol. Treatment will be performed under standardized radiation safety conditions. Patients will undergo baseline clinical and imaging evaluation prior to therapy and will be followed prospectively with clinical assessment, laboratory tests, and serial imaging (including FAPI PET/CT and/or conventional imaging) to evaluate treatment response, biodistribution, dosimetry, safety, and tolerability. Adverse events will be monitored and recorded throughout the study period in accordance with CTCAE criteria.
Drug: Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)
Yttrium-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.
Also known as: Y-90-labeled FAPI, Y-90 FAPI Radioligand Therapy, FAP-Targeted Radionuclide Therapy
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.
Time frame: From first dose of Y-90 FAPI up to 6 months
Objective Tumor Response
Proportion of patients achieving complete or partial metabolic response on FDG PET/CT according to PERCIST criteria.
Time frame: Baseline to 3 months after treatment
Dosimetry
Absorbed radiation dose to tumor lesions and critical organs calculated using post-therapy SPECT/CT imaging.
Time frame: Within 7 days after Y-90 FAPI administration
Disease Control Rate
Proportion of patients achieving complete response, partial response, or stable disease after Y-90 FAPI therapy.
Time frame: Up to 6 months
Progression-Free Survival (PFS)
Time from Y-90 FAPI administration to documented disease progression or death from any cause.
Time frame: Up to 12 months
Overall Survival (OS)
Time from Y-90 FAPI therapy to death from any cause.
Time frame: Up to 12 months
Correlation of FAP Expression With Treatment Response
Relationship between baseline Ga-68 FAPI PET/CT uptake values and post-treatment response outcomes.
Time frame: Baseline to 3 months
Plan to share: No
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization