NCT06099639

Medical Access Program for Patritumab Deruxtecan

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

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this Medical Access Program is to provide access to HER3-DXd for eligible patients with NSCLC who, in their treating physician's opinion, have an unmet clinical need which cannot be treated with approved and commercially available drugs and who cannot enter a clinical trial prior to commercial availability.

Detailed description

This is a Medical Access Program which will be available to adult patients in the US with metastatic or locally advanced EGFRm NSCLC who have received at least 2 prior systemic therapies, who have no alternative commercially available treatment options, and are not able to enter a clinical trial. In this Medical Access Program, eligible patients will be treated with HER3-DXd and will continue to receive treatment until any of the following occurs: * Disease progression * Unacceptable toxicity * The benefit-risk no longer favors the individual * HER3-DXd becomes commercially available in the US and reimbursement is approved for the concerned indication of the Medical Access Program. * Withdrawal of consent * Pregnancy * Physician discretion * Death

Conditions

• Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	HER3-DXd	5.6 mg/kg Q3W \[on Day 1 of each 21-day cycle\]) infused IV over approximately 90 minutes

Timeline

• First posted: 2023-10-25
• Last updated: 2025-06-08

Locations

21 sites across 1 country: United States