NCT07436858

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer (NSCLC)
• HER2 Expression
• HER2 Gene Mutation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PET imaging with ⁸⁹Zr-trastuzumab	Participants will receive one injection of ⁸⁹Zr-trastuzumab and undergo a PET/CT scan four days later.
DIAGNOSTIC_TEST	Blood sampling for pharmacokinetics	To 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.

Timeline

• Start date: 2026-08-01
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Netherlands