Using 68Ga-MY6349 PET/CT to track response to Trop2 antibody‑drug therapy in NSCLC
Official title: Evaluation of Treatment Response to Trop2 ADC by 68Ga-MY6349 PET/CT in NSCLC
Run by The First Affiliated Hospital of Xiamen University · NCT07151898 · Data updated 2026-11-12
This will see if serial 68Ga-MY6349 PET/CT scans can predict how people with metastatic NSCLC respond to Trop2-targeted antibody‑drug treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | The First Affiliated Hospital of Xiamen University Academic / other |
| Locations | 1 site (Xiamen, Fujian) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | May 1, 2027 |
| Study ends | May 1, 2027 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT07151898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically or cytologically confirmed metastatic NSCLC who have at least one measurable lesion, prior systemic therapy, ECOG 0–1, and willingness to undergo baseline and on‑treatment 68Ga‑MY6349 PET/CT scans while receiving Trop2‑ADC.
✕Probably not a fit
Patients with significant liver or kidney impairment, an estimated life expectancy under three months, ECOG >1, or those unable/unwilling to have serial PET/CT scans are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with metastatic non–small cell lung cancer who are starting Trop2‑targeted antibody‑drug conjugate (Trop2‑ADC) therapy will have 68Ga-MY6349 PET/CT scans at baseline and after two and/or four treatment cycles. Tumor uptake will be quantified using SUVmax and SUVmean and changes over time will be recorded. Imaging results will be compared with clinical and radiographic response by RECIST 1.1 to test whether PET signal changes predict treatment benefit. The protocol is observational and requires participants to tolerate serial PET/CT imaging and have ECOG performance status 0–1.
Why it matters
Potential benefit: If successful, this imaging approach could let clinicians identify early which patients are benefiting from Trop2‑ADC and avoid ineffective therapy.
How similar studies have gone: Trop2‑targeted ADCs have shown activity in other cancers, but using 68Ga‑MY6349 PET/CT as a predictive biomarker for Trop2‑ADC response in NSCLC is relatively novel with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China Recruiting
Study contacts
- Study coordinator: Liang Zhao
- Email: wzhaoliang01@163.com
- Phone: 86 18818350620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.