The investigators investigate whether PET imaging with ⁸⁹Zr-trastuzumab can reliably demonstrate the extent of tracer accumulation in tumors of patients with HER2-mutated or HER2-overexpressing non-small cell lung cancer (NSCLC). The aim is to determine whether differences in tracer uptake can be detected between these groups, as translational studies indicate that HER2-mutated tumors may internalize trastuzumab-based agents more efficiently than tumors that solely overexpressed HER2.
Signed written informed consent
Age≥ 18 years, willing and able to comply with the protocol as judged by the investigator
Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at screening.
HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation
Contraindications for systemic treatment (as will be assigned by the treating physician)
Pregnant or lactating women
Prior allergic reaction to immunoglobulins or immunoglobulin allergy
Inability to comply with study procedures
Single group
PET imaging with ⁸⁹Zr-trastuzumab
Diagnostic testParticipants will receive one injection of ⁸⁹Zr-trastuzumab and undergo a PET/CT scan four days later.
Blood sampling for pharmacokinetics
Diagnostic testTo assess the pharmacokinetics of ⁸⁹Zr-trastuzumab, the investigators collect blood samples at multiple time points following tracer administration. Samples are drawn at 10 minutes, 30 minutes, 1 hour, and 2 hours post-injection, and again on day 4 and day 7 post-injection.
Standard uptake values (SUVs) in tumor lesions
measurable tumor lesions and enlarged lymph nodes (\>20 mm)
Tumor-to-background ratio (TBR)
Tumor-to-plasma ratio (TPR)
SUVs in tumor lesions
Total expression volume (TEV)
The sum of lesion volumes with uptake above the bloodpool
Visual PET-based heterogeneity assessment
Intralesion heterogeneity (only for >1.5 cm)
Whole-blood and plasma pharmacokinetics of ⁸⁹Zr-trastuzumab: AUCplasma
Whole-blood and plasma pharmacokinetics of ⁸⁹Zr-trastuzumab: Cplasma
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