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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PET imaging with ⁸⁹Zr-trastuzumab
  • Blood sampling for pharmacokinetics

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

1
The Netherlands Cancer Institute - Antoni van Leeuwenhoek1066CX, AmsterdamNorth Holland, Netherlands

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor