PET/CT for Trop2 ADC Response Evaluation NSCLC
Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in NSCLC
1 other identifier
observational
50
1 country
1
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 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2025
CompletedFirst Submitted
Initial submission to the registry
August 26, 2025
CompletedFirst Posted
Study publicly available on registry
September 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
September 3, 2025
July 1, 2025
2 years
August 26, 2025
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The predictive value of series 68Ga-MY6349 PET/CT in patients with NSCLC who received Trop2-ADC therapy
For 68Ga-MY6349 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. SUVmax values obtained at baseline and after two and/or four cycles of Trop2-ADC therapy were collected and analyzed in relation to treatment response.
2025.5-2027.5
Secondary Outcomes (1)
Correlation Between PET Parameters and Survival
2025.5-2027.5
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Adult patients with previously treated metastatic NSCLC (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report).
You may qualify if:
- 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
You may not qualify if:
- Evidence of significantly impaired hepatic or renal function
- Estimated life expectancy of less than 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2025
First Posted
September 3, 2025
Study Start
May 1, 2025
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
September 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share