Whole Body HER3 Quantification With Radiolabelled Patritumab Deruxtecan (HER3-DXd) PET/CT
Sponsor: The Netherlands Cancer Institute + Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
The optimal imaging dose patritumab deruxtecan to co-inject with 89Zr-Patritumab deruxtecan (HER3-DXd), defined by adequate visualisation of the circulation five days after tracer injection.
Time frame: From the date of cycle 1, day 1 until the date of cycle 1, day 5.
Secondary Endpoints
SUV of tumor lesions
Eligibility Criteria
Inclusion Criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Have a histologically or cytologically confirmed diagnosis of (locally) advanced stage EGFR mutation positive NSCLC, not amenable for curative intent treatment. 3. Have measurable disease according to RECIST 1.1. 4. At least two lesions with a long axis diameter ≥2 cm. 5. Have received at least one line of EGFR TKI treatment for (locally) advanced stage NSCLC. 6. In case the tumor is positive for T790M mutation, prior treatment with a third generation EGFR TKI is mandatory. 7. Patients must be ≥18 years of age. 8. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 at the time of Screening. 9. 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 or ≥100 × 109/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1 Day 1 to meet eligibility) …
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