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HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

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Trial Profile

HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects With Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Patritumab Deruxtecan (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERTHENA-Lung01
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 29 May 2025 According to Daiichi Sankyo company media release, the Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo and Merck outside of the United States and Canada, patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial, has been voluntarily withdrawn. The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial.
  • 20 Aug 2024 Planned End Date changed from 1 Nov 2024 to 30 Jan 2026.
  • 26 Jun 2024 According to a Daiichi Sankyo Company media release,U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo(TSE4568) and merck patritumab deruxtecan for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer previously treated with two or more systemic therapies on basis of results of this trial.

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