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NCT06099639NO_LONGER_AVAILABLE

Medical Access Program for Patritumab Deruxtecan

Medical Access Program for Patritumab Deruxtecan (HER3 DXd, U3-1402)

Sponsor: Daiichi Sankyo

No open prediction endpoints

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Key Facts

Study type
EXPANDED_ACCESS
Conditions
Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Interventions
HER3-DXd
Enrollment
Primary completion
Study completion
First posted
Oct 2023
Last updated
Jun 2025

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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Source

Open on ClinicalTrials.gov