Medical Access Program for Datopotamab Deruxtecan in EGFRm NSCLC Patients

NCT06279728 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Datopotamab deruxtecan

6 mg/kg intravenous infusion Q3W (on Day 1 of each 21-day cycle)

Sponsors & Collaborators

Principal Investigators

  • Global Medical Affairs · Daiichi Sankyo

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279728 on ClinicalTrials.gov