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Studieoverzicht

Study name: Whole body HER3 quantification with radiolabelled Patritumab deruxtecan (HER3-DXd) PET/CT

Histology NSCLC
Tumor stage Stage IV
Host / recruiting sites Antoni van Leeuwenhoek
Enrollment Recruiting
Therapy line Later line (≥2L)
Design

Single-center, single-arm, open-label imaging study
Intervention

Patritumab-deruxtecan
Key outcome parameters

Identification of the optimal non-radiolabeled patritumab deruxtecan dose to be co-injected with 89Zr-Patritumab deruxtecan to allow optimal 89Zr-Patritumab deruxtecan PET imaging.
Key inclusion criteria
  • Have a histologically or cytologically confirmed diagnosis of (locally) advanced stage EGFR mutation positive NSCLC, not amenable for curative intent treatment.
  • Be willing to provide a qualifying tumor tissue specimen. A pretreatment tumor biopsy (if medically feasible) or otherwise archival tumor tissue (when available and obtained after the last line of therapy) is required
Key exclusion criteria
  • Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during screening.
  • Inadequate washout period prior to Cycle 1 Day 1, defined as: a. Whole brain radiation therapy
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