Medical Access Program for Patritumab Deruxtecan
Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)
Sponsor: Daiichi Sankyo
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Eligibility Criteria
Inclusion Criteria - Initial Requests * Signed informed consent. * Male or female aged ≥18 years (or local regulatory requirements). * Histologically or cytologically documented locally advanced or metastatic EGFRm NSCLC not amenable to curative surgery or radiation. * Documentation of radiological disease progression whilst on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Patients must have received both of the following: 1. Prior treatment with any EGFR TKI, with at least one of them being osimertinib. Patients receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to the first infusion of HER3 DXd. 2. Systemic therapy with at least 1 PBC regimen. * Documentation of an EGFR-activating mutation detected from tumor tissue or blood (exon 19 deletion or L858R mutation). * Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at the time of entering the Medi…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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