NCT07151898

PET/CT for Trop2 ADC Response Evaluation NSCLC

Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in NSCLC

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate whether serial 68Ga-MY6349 PET/CT imaging can serve as a noninvasive biomarker to predict the therapeutic efficacy of Trop2-targeted antibody-drug conjugate (Trop2-ADC) therapy in NSCLC patients.

Detailed description

Patients diagnosed with metastatic Non-Small Cell Lung Cancer（NSCLC） will undergo 68Ga-MY6349 PET/CT imaging at baseline and after two and/or four cycles of Trop2-ADC therapy. Tumor uptake will be quantified using both maximum standardized uptake value (SUVmax) and mean SUV (SUVmean). Imaging changes will be correlated with treatment response to assess the utility of 68Ga-MY6349 PET/CT as a predictive biomarker.

Conditions

• NSCLC
• Trop2
• PET/CT

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-MY6349 PET/CT	Each participant will receive an intravenous injection of 68Ga-MY6349 and undergo PET/CT imaging at baseline and following two and/or four cycles of Trop2-ADC therapy.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-09-03
• Last updated: 2025-09-03

Locations

1 site across 1 country: China