Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation … (NCT07436858) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Whole Body HER2 Quantification With 89Zr-Trastuzumab PET/CT to Asses Zr-trastuzumab Accumulation in HER2-mutated and HER2-overexpressing Metastatic Non-small Cell Lung Cancer
Netherlands20 participantsStarted 2026-08-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
* Patients with histologically or cytologically confirmed diagnosis of advanced stage:
* HER2 overexpression, defined as an immunohistochemistry score (IHC) of 2+ or 3+ in at least 10% of tumour cells without an activating HER2 mutation
* HER2 activating (insertion) mutation diagnosed through RNA sequencing (RNAseq)
* Disease progression after at least one line of platinum-based chemotherapy ± immunotherapy and starting (new) systemic treatment.
* Be willing to provide a recent tumor tissue specimen after the last line of therapy. Samples must be of sufficient quantity and of adequate tumor tissue content.
* Able to undergo PET imaging procedures.
* Measurable disease according to RECIST 1.1.
* At least two measurable lesions with a long axis diameter ≥2 cm.
* Adequate organ and bone marrow function within 21 days prior to tracer injection, defines as:
Laboratory Test Laboratory Value Platelet count ≥100 000/mm3 or ≥100 × 109/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) Hemoglobin ≥9.0 g/dL or 5.6 mmol/L (transfusion and/or growth factor support is allowed) Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 × 109/L Aspartate aminotransferase /alanine aminotransferase ≤3 × ULN (if liver metasta…
What they're measuring
1
Standard uptake values (SUVs) in tumor lesions
Timeframe: During PET imaging with ⁸⁹Zr-trastuzumab