Clinical trial · Interventional
Yittrium-90(Y-90) Fibroblast Activation Protein Inhibitor (FAPI) Therapy in Patients With Non-Small Cell Lung Cancer (Phase II)
A Novel Therapeutic Target in Non-Small Cell Lung Cancer: Evaluation of the Efficacy of Yttrium-90 (Y-90) Fibroblast Activation Protein Inhibitor (FAPI) - A Phase II Study
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Lung Carcinoma | Lung Carcinoma | CURATED_BROADER | 0.78 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Y-90 FAPI Radionuclide Therapy
- description
- 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.
- interventionNames
- Drug: Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)
Primary outcomes (2)
- measure
- 1. Safety and Tolerability
- timeFrame
- From first dose of Y-90 FAPI up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Histologically confirmed diagnosis of non-small cell lung cancer (NSCLC) * Metastatic disease * Prior staging with F-18 FDG PET/CT * Ga-68 FAPI PET/CT demonstrating increased tracer uptake in tumor lesions (SUVmax ≥10 in more than 50% of metastatic lesions) * Disease progression or resistance after all standard approved therapies as determined by a multidisciplinary tumor board * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Adequate organ function: * Serum creatinine ≤150 μmol/L * Hemoglobin ≥8.0 g/dL * White blood cell count ≥2.0 × 10⁹/L * Platelet count ≥50 × 10⁹/L * Total bilirubin ≤3 × upper limit of normal * Serum albumin ≥2.0 g/dL * Ability to understand and willingness to sign written informed consent Exclusion Criteria: * Age \<18 years * Diagnosis of small cell lung cancer * History of another active malignancy * Pregnancy or breastfeeding * Severe uncontrolled medical illness that would interfere with study participation * Refusal or inability to provide written informed consent
References
Publications (3)
- BACKGROUNDRathke H, Fuxius S, Giesel FL, Lindner T, Debus J, Haberkorn U, Kratochwil C. Two Tumors, One Target: Preliminary Experience With 90Y-FAPI Therapy in a Patient With Metastasized Breast and Colorectal Cancer. Clin Nucl Med. 2021 Oct 1;46(10):842-844. doi: 10.1097/RLU.0000000000003842. PMID 34392291
- BACKGROUNDFendler WP, Pabst KM, Kessler L, Fragoso Costa P, Ferdinandus J, Weber M, Lippert M, Lueckerath K, Umutlu L, Kostbade K, Mavroeidi IA, Schuler M, Ahrens M, Rischpler C, Bauer S, Herrmann K, Siveke JT, Hamacher R. Safety and Efficacy of 90Y-FAPI-46 Radioligand Therapy in Patients with Advanced Sarcoma and Other Cancer Entities. Clin Cancer Res. 2022 Oct 3;28(19):4346-4353. doi: 10.1158/1078-0432.CCR-22-1432. PMID 35833949
- BACKGROUNDPrive BM, Boussihmad MA, Timmermans B, van Gemert WA, Peters SMB, Derks YHW, van Lith SAM, Mehra N, Nagarajah J, Heskamp S, Westdorp H. Fibroblast activation protein-targeted radionuclide therapy: background, opportunities, and challenges of first (pre)clinical studies. Eur J Nucl Med Mol Imaging. 2023 Jun;50(7):1906-1918. doi: 10.1007/s00259-023-06144-0. Epub 2023 Feb 23. PMID 36813980