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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Standard uptake values (SUVs) in tumor lesions
Timeframe: During PET imaging with ⁸⁹Zr-trastuzumab