OncoMatch/Clinical Trials/NCT06222489
Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT
Is NCT06222489 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies 89Zr-Patritumab deruxtecan for non-small cell lung carcinoma.
Treatment: 89Zr-Patritumab deruxtecan — Activity of patritumab deruxtecan (U3-1402; HER3-DXd) has been shown in a phase I/II study in patients with HER3 expressing breast cancer as well as in a phase I study in patients with EGFR TKI refractory EGFR mutation positive NSCLC with a preliminary ORR of 25%. HER3 expression can be seen in multiple tumor types and is therefore an attractive target for antibody drug conjugate (ADC) treatment. However, intra- and intertumor heterogeneity of HER3 expression might be substantial, as is seen for HER2, and might contribute to treatment failure or heterogeneous responses. In addition, HER3 expression is dynamic and has been shown to change over time. In order to identify patients that may benefit most from treatment with patritumab deruxtecan, better knowledge of the in vivo behaviour of the drug is warranted. One way to visualize this behaviour is positron emission tomography (PET) imaging with radiolabelled antibodies (immune-PET). 89Zr-Patritumab deruxtecan PET/CT can assess HER3 expression non-invasively at a whole body level, including sites that may be difficult to biopsy. It also visualizes and quantifies biodistribution of patritumab deruxtecan, thereby obtaining valuable information for safety and toxicity analyses.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
EGFR mutation positive NSCLC
Allowed: EGFR T790M
In case the tumor is positive for T790M mutation, prior treatment with a third generation EGFR TKI is mandatory.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor — (locally) advanced stage
Have received at least one line of EGFR TKI treatment for (locally) advanced stage NSCLC.
Cannot have received: HER3 antibody
Prior treatment with an HER3 antibody
Cannot have received: antibody drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (trastuzumab deruxtecan)
Prior treatment with an ... ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan)
Lab requirements
Blood counts
Platelet count ≥100,000/mm3; Hemoglobin (Hgb) ≥9.0 g/dL; Absolute neutrophil count (ANC) ≥1500/mm3; Serum albumin ≥2.5 g/dL
Kidney function
Creatinine clearance (CrCl) ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl
Liver function
AST/ALT ≤3 × ULN (if liver metastases are present, ≤5 × ULN); Total bilirubin ≤1.5 × ULN if no liver metastases (<3 × ULN in the presence of documented Gilbert's Syndrome or liver metastases)
Cardiac function
QTcF >470 ms for females and >450 ms for males excluded; LVEF <50% by ECHO or MUGA excluded; Resting systolic BP >180 mmHg or diastolic BP >110 mmHg excluded; Myocardial infarction within 6 months excluded; NYHA Classes 2 to 4 within 28 days excluded; Uncontrolled angina pectoris within 6 months excluded; Cardiac arrhythmia requiring antiarrhythmic treatment excluded.
Has adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1, Day 1, defined as: Platelet count ≥100 000/mm3 ... Hemoglobin (Hgb) ≥9.0 g/dL ... ANC ≥1500/mm3 ... Creatinine clearance (CrCl) ≥30 mL/min ... AST/ALT ≤3 × ULN (if liver metastases are present, ≤5 × ULN) ... Total bilirubin (TBL) ≤1.5 × ULN if no liver metastases (<3 × ULN in the presence of documented Gilbert's Syndrome or liver metastases) ... Serum albumin ≥2.5 g/dL ... PT/INR/aPTT ≤1.5 × ULN except for subjects on anticoagulants ... Cardiac: see exclusion criteria.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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