NCT06279728

Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients

Medical Access Program for Datopotamab Deruxtecan (Dato-DXd, DS-1062a)

• Status: Approved For Marketing
• 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 (also referred to as an Expanded Access Program in the USA) is to provide access to Dato-DXd for eligible patients with previously treated advanced or metastatic EGFR mutated non-small cell lung cancer (NSCLC) who, in their treating physician's opinion, have an unmet clinical need, are unlikely to obtain optimal benefit from currently approved and commercially available drugs, and who cannot enter a suitable clinical trial.

Detailed description

This is a Medical Access Program that will be available to adult patients with previously treated advanced or metastatic EGFR mutated NSCLC who have no suitable treatment options and are not able to enter a clinical trial. Patients enrolled in the Medical Access Program can continue treatment until any of the following occurs: * Disease progression * Unacceptable toxicity * The benefit-risk no longer favors the individual * Dato-DXd becomes commercially available and reimbursement is approved * The patient chooses to discontinue treatment * Withdrawal of consent * Pregnancy * Physician discretion * Death Patients enrolled in the Medical Access Program have an option to participate in collection of safety-focused clinical practice data. This will contribute towards better understanding of the clinical experience of treatment with Dato-DXd. Participation in this optional data collection will have no bearing on receipt of treatment.

Conditions

• EGFRm Advanced Non-Small Cell Lung Cancer
• EGFRm Metastatic Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Datopotamab deruxtecan	6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Timeline

• First posted: 2024-02-28
• Last updated: 2025-07-03

Locations

14 sites across 1 country: United States