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NCT Number: NCT07151898

PET/CT for Trop2 ADC Response Evaluation NSCLC

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-MY6349 PET/CT

Diagnostic Test

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 outcomes

  1. The predictive value of series 68Ga-MY6349 PET/CT in patients with NSCLC who received Trop2-ADC therapy

    Time frame: 2025.5-2027.5

    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.

Secondary outcomes

  1. Correlation Between PET Parameters and Survival

    Time frame: 2025.5-2027.5

    Progression-free survival (PFS) amd overall survival (OS) will be monitored and analyzed in relation to imaging parameters obtained from serial 68Ga-MY6349 PET/CT scans.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Zhao

CONTACT

[email protected]

86 18818350620

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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