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Recruiting NCT07151898

PET/CT for Trop2 ADC Response Evaluation NSCLC

— Observational NSCLC Trop2 PET/CT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-MY6349 PET/CT.
Who it may be relevant to
Registry conditions: NSCLC, Trop2, PET/CT. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The predictive value of series 68Ga-MY6349 PET/CT in patients with NSCLC who received Trop2-ADC therapy [Time frame: 2025.5-2027.5]
Secondary outcome measures (1)
  • Correlation Between PET Parameters and Survival [Time frame: 2025.5-2027.5]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • Evidence of significantly impaired hepatic or renal function
  • Estimated life expectancy of less than 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • The First Affiliated Hospital of Xiamen University — Xiamen

Identifiers

NCT: NCT07151898 · XMYY-2025KY101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗