NCT07500285Not yet recruitingPhase 2
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 · Last updated 31 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 28 Feb 2026
- Start date
- 10 Apr 2026
- Primary completion date
- 15 Jun 2027
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Diseases
- Lung cancer
- NCT number
- NCT07500285
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 10
- From 10 Apr 2026 to the primary completion date, 15 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of small cell lung cancer
- History of another active malignancy
- Severe uncontrolled medical illness that would interfere with study participation
Age
- Age \<18 years
Other
- Pregnancy or breastfeeding
- Refusal or inability to provide written informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prof. Dr. Cemil Taşcıoğlu City Hospital Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.