Non-Small Cell Lung CancerPhase 2NCT07500285
Yittrium-90(Y-90) Fibroblast Activation Protein Inhibitor (FAPI) Therapy in Patients With Non-Small Cell Lung Cancer (Phase II)
A Phase 2 study testing Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) in people with Non-Small Cell Lung Cancer and Metastatic Lung Carcinoma, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Metastatic Lung Carcinoma
- What is being tested?
- Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Apr 2026to 15 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, 34384
Muge O Tamam, Professor, +905324082376, mugetamam@yahoo.com
Merve N Acar tayyar, +905532079693, nurmacar13@gmail.com
Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul, 34384
Muge Oner Tamam, Proffesor, 905324082376, mugetamam@yahoo.com
Merve Nur Acar Tayyar, MD, 905532079693, nurmacar13@gmail.com
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)
- Keywords
- non-small cell lung cancer, Fibroblast Activation Protein, Yttrium-90 FAPI, Targeted Radionuclide Therapy, Phase II Clinical Trial, 90Y-FAPI Radioligand Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)Drug
Also called Y-90-labeled FAPI, Y-90 FAPI Radioligand Therapy, FAP-Targeted Radionuclide Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| Y-90 FAPI Radionuclide Therapy | Experimental | 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. Receives: Drug: Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to 3 months after treatment
Secondary outcomes (5)
Dosimetry
Absorbed radiation dose to tumor lesions and critical organs calculated using post-therapy SPECT/CT imaging.
Measured: 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.
Measured: Up to 6 months
Progression-Free Survival (PFS)
Time from Y-90 FAPI administration to documented disease progression or death from any cause.
Measured: Up to 12 months
Overall Survival (OS)
Time from Y-90 FAPI therapy to death from any cause.
Measured: 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.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start10 Apr 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, open-label Phase II clinical study designed to evaluate the safety, dosimetry, and therapeutic efficacy of Yttrium-90-labeled Fibroblast Activation Protein inhibitor (Y-90 FAPI) in patients with chemotherapy-resistant metastatic non-small cell lung cancer (NSCLC). Eligible patients demonstrating significant FAP expression on Ga-68 FAPI PET/CT imaging will receive intravenous Y-90 FAPI radionuclide therapy. Clinical, biochemical, radiological, and dosimetric assessments will be performed to evaluate treatment response and safety.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Muge Oner Tamam, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500285
- Sponsor's protocol ID
- 49724
- Other IDs
- 49724
- Status last verified
- Mar 2026
- First submitted
- 28 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rathke 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.
PubMed 34392291Fendler 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.
PubMed 35833949Prive 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.
PubMed 36813980
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07500285
- Acronym / sponsor ID
- 49724
- Keywords
- non-small cell lung cancer, Fibroblast Activation Protein, Yttrium-90 FAPI, Targeted Radionuclide Therapy, Phase II Clinical Trial, 90Y-FAPI Radioligand Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, open-label Phase II clinical study designed to evaluate the safety, dosimetry, and therapeutic efficacy of Yttrium-90-labeled Fibroblast Activation Protein inhibitor (Y-90 FAPI) in patients with chemotherapy-resistant metastatic non-small cell lung cancer (NSCLC). Eligible patients demonstrating significant FAP expression on Ga-68 FAPI PET/CT imaging will receive intravenous Y-90 FAPI radionuclide therapy. Clinical, biochemical, radiological, and dosimetric assessments will be performed to evaluate treatment response and safety.
| Arm | Type | Receives |
|---|---|---|
| Y-90 FAPI Radionuclide Therapy | Experimental | Drug: Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI)Also: Y-90-labeled FAPI, Y-90 FAPI Radioligand Therapy, FAP-Targeted Radionuclide TherapyYttrium-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. | Drug | Y-90 FAPI Radionuclide Therapy |
Primary outcome
1. Safety and Tolerability
Time frame: From first dose of Y-90 FAPI up to 6 months
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
Time frame: Baseline to 3 months after treatment
Proportion of patients achieving complete or partial metabolic response on FDG PET/CT according to PERCIST criteria.
5 secondary outcomes
Dosimetry
Time frame: Within 7 days after Y-90 FAPI administration
Disease Control Rate
Time frame: Up to 6 months
Progression-Free Survival (PFS)
Time frame: Up to 12 months
Overall Survival (OS)
Time frame: Up to 12 months
Correlation of FAP Expression With Treatment Response
Time frame: Baseline to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Background: PubMed 34392291Rathke 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.
- Background: PubMed 35833949Fendler 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.
- Background: PubMed 36813980Prive 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) in people with Non-Small Cell Lung Cancer and Metastatic Lung Carcinoma, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muge O. Tamam, Professor (+90532402376, mugetamam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Safety and Tolerability (time frame: From first dose of Y-90 FAPI up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07500285, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.