HER2 Expression / Blood sampling for pharmacokinetics / PET imaging with ⁸⁹Zr-trastuzumab · Phase 1 Trial

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

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 1 diagnostic imaging study not yet recruiting, designed to evaluate ⁸⁹Zr-trastuzumab PET accumulation in HER2-mutated versus HER2-overexpressing NSCLC. No outcome data are available in this registry record; the study aims to determine feasibility and whether tracer uptake differs between HER2 phenotypes.

What was studied

Phase 1, Interventional, Single Group, Open label, Diagnostic purpose. Lung Cancer (NSCLC), HER2 Expression, HER2 Gene Mutation; age from 18 Years. Intervention: HER2-mutated NSCLC cohort and HER2-overexpressing NSCLC coh…. Compared with: Comparison between HER2-mutated and HER2-overexpressing tumor phenotypes. n = 20. 1 site: Netherlands.

Key findings

Safety

Primary outcome is a surrogate imaging measure (SUVs), not clinical efficacy or safety outcome.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 diagnostic imaging study in early recruitment with no results posted; designed to assess tracer accumulation and feasibility of detecting HER2 phenotype differences.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Standard uptake values (SUVs) in tumor lesions (assessed at During PET imaging with ⁸⁹Zr-trastuzumab)

DesignPhase 1, Interventional, Single Group, Open label, Diagnostic purpose

PopulationLung Cancer (NSCLC), HER2 Expression, HER2 Gene Mutation; age from 18 Years

Sample size20

InterventionHER2-mutated NSCLC cohort and HER2-overexpressing NSCLC coh…

ComparatorComparison between HER2-mutated and HER2-overexpressing tumor phenotypes

Setting1 site: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment20

PhasePhase 1

Primary outcome measureStandard uptake values (SUVs) in tumor lesions during PET imaging with ⁸⁹Zr-trastuzumab

Caveats

Registry record; no results posted. Study not yet recruiting.
No sample size justification, power calculation, or detailed eligibility criteria reported.
No blinding, randomization method, or follow-up duration specified.
Primary outcome is a surrogate imaging measure (SUVs), not clinical efficacy or safety outcome.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional diagnostic study with planned comparative groups; design appropriate for feasibility.

Directness

moderate

Directly measures tracer accumulation (SUVs) in target tumors; mechanistic rather than clinical outcome.

Consistency

insufficient

No results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or outcome assessment methods.

Sample adequacy

limited

Estimated enrollment 20 participants; small Phase 1 sample, no power calculation stated.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07436858). This is a study registration, not published results. Lead sponsor: The Netherlands Cancer Institute. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 20 participants (ESTIMATED). Conditions: Lung Cancer (NSCLC), HER2 Expression, HER2 Gene Mutation. Interventions: DIAGNOSTIC_TEST: PET imaging with ⁸⁹Zr-trastuzumab; DIAGNOSTIC_TEST: Blood sampling for pharmacokinetics. Primary outcome measures: Standard uptake values (SUVs) in tumor lesions , During PET imaging with ⁸⁹Zr-trastuzumab. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

HER2 ExpressionBlood sampling for pharmacokineticsPET imaging with ⁸⁹Zr-trastuzumabNCT07436858The Netherlands Cancer InstituteHER2 Gene MutationLung Cancer (NSCLC)