Status:
RECRUITING
PET/CT for Trop2 ADC Response Evaluation NSCLC
Lead Sponsor:
The First Affiliated Hospital of Xiamen University
Conditions:
NSCLC
Trop2
Eligibility:
All Genders
18+ years
Brief 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 pa...
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 qua...
Eligibility Criteria
Inclusion
- adult patients (aged 18 years or order)
- histologically or cytologically confirmed metastatic NSCLC previously treated with systemic therapy, supported by imaging (e.g. CT, MRI), tumor markers, or pathology reports
- presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
- willingness to undergo serial 68Ga-MY6349 PET/CT scans before and during Trop2-ADC therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Ability to provide written informed consent and, where applicable, assent in accordance with the requirements of the Clinical Research Ethics Committee
Exclusion
- Evidence of significantly impaired hepatic or renal function
- Estimated life expectancy of less than 3 months
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07151898
Start Date
May 1 2025
End Date
May 1 2027
Last Update
September 3 2025
Active Locations (1)
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1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000