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
New targeted therapy for advanced non-small cell lung cancer
Plain English Summary
Yittrium-90(Y-90) Fibroblast Activation Protein Inhibitor (FAPI) Therapy in Patients With Non-Small Cell Lung Cancer (Phase II) is a Phase 2 clinical trial sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization studying Non-Small Cell Lung Cancer, Metastatic Lung Carcinoma. This study tests a new targeted radiation therapy called Y-90 FAPI for lung cancer. It is for patients with non-small cell lung cancer that has spread and did not respond to standard treatments. Participants will receive Y-90 FAPI intravenously, and will have regular check-ups and scans. Alternative treatments may include chemotherapy, immunotherapy, or other targeted therapies, depending on the patient's specific situation. The trial aims to enroll 10 participants.
Official 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 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with a confirmed diagnosis of non-small cell lung cancer that has spread. Patients must have had their cancer assessed with specific imaging scans (F-18 FDG PET/CT and Ga-68 FAPI PET/CT) showing high uptake in tumors. Individuals must have progressed or become resistant to all standard approved therapies. Patients should have good organ function and a performance status that allows for participation. This trial is studying Non-Small Cell Lung Cancer, Metastatic Lung Carcinoma, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes will measure how safe and well-tolerated the new therapy is, and how well it shrinks tumors. The specific primary outcome measures are: 1. Safety and Tolerability (From first dose of Y-90 FAPI up to 6 months); Objective Tumor Response (Baseline to 3 months after treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a critical need for new treatments for advanced non-small cell lung cancer, which has a poor prognosis and limited options after standard therapies fail. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Non-Small Cell Lung Cancer, Metastatic Lung Carcinoma, where improved treatment options are needed.
Investor Insight
This trial explores a novel therapeutic approach for a common and deadly cancer, potentially opening a new treatment avenue if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this trial is a good fit for you, considering your specific cancer and treatment history. Participation involves receiving the Y-90 FAPI treatment and attending regular appointments for monitoring and scans. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 10 participants
Interventions
- 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.
Primary Outcomes
- 1. Safety and Tolerability (From first dose of Y-90 FAPI up to 6 months)
- Objective Tumor Response (Baseline to 3 months after treatment)
Secondary Outcomes
- Dosimetry (Within 7 days after Y-90 FAPI administration)
- Disease Control Rate (Up to 6 months)
- Progression-Free Survival (PFS) (Up to 12 months)
- Overall Survival (OS) (Up to 12 months)
- Correlation of FAP Expression With Treatment Response (Baseline to 3 months)
Full Eligibility Criteria
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
Trial Locations
- Prof. Dr. Cemil Taşcıoğlu City Hospital, Istanbul, Turkey (Türkiye)
- Prof. Dr. Cemil Taşçıoğlu City Hospital, Istanbul, Turkey (Türkiye)
Frequently Asked Questions
What is clinical trial NCT07500285?
NCT07500285 is a Phase 2 INTERVENTIONAL study titled "Yittrium-90(Y-90) Fibroblast Activation Protein Inhibitor (FAPI) Therapy in Patients With Non-Small Cell Lung Cancer (Phase II)." It is currently not yet recruiting and is sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. The trial targets enrollment of 10 participants.
What conditions does NCT07500285 study?
This trial investigates treatments for Non-Small Cell Lung Cancer, Metastatic Lung Carcinoma. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07500285?
The interventions being studied include: Yttrium-90-Labeled Fibroblast Activation Protein Inhibitor (Y-90 FAPI) (DRUG). 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.
What does Phase 2 mean for NCT07500285?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT07500285?
This trial is currently "Not Yet Recruiting." It started on 2026-04-10. The estimated completion date is 2027-11-15.
Who is sponsoring NCT07500285?
NCT07500285 is sponsored by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07500285?
The trial aims to enroll 10 participants. The trial has not yet started recruiting.
How is NCT07500285 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07500285?
The primary outcome measures are: 1. Safety and Tolerability (From first dose of Y-90 FAPI up to 6 months); Objective Tumor Response (Baseline to 3 months after treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07500285 being conducted?
This trial is being conducted at 2 sites, including Istanbul (Turkey (Türkiye)).
Where can I find official information about NCT07500285?
The official record for NCT07500285 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07500285. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07500285 testing in simple terms?
This study tests a new targeted radiation therapy called Y-90 FAPI for lung cancer. It is for patients with non-small cell lung cancer that has spread and did not respond to standard treatments.
Why is this trial significant?
This trial addresses a critical need for new treatments for advanced non-small cell lung cancer, which has a poor prognosis and limited options after standard therapies fail.
What are the potential risks of participating in NCT07500285?
Potential side effects may include fatigue, nausea, and effects on blood counts. Radiation therapy can have specific risks, and the long-term effects of Y-90 FAPI are still being studied. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07500285?
Ask your doctor if this trial is a good fit for you, considering your specific cancer and treatment history. Participation involves receiving the Y-90 FAPI treatment and attending regular appointments for monitoring and scans. Be prepared for potential side effects and discuss any concerns with your healthcare team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07500285 signal from an investment perspective?
This trial explores a novel therapeutic approach for a common and deadly cancer, potentially opening a new treatment avenue if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive Y-90 FAPI intravenously, and will have regular check-ups and scans. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Non-Small Cell Lung Cancer Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.