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A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

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Trial Profile

A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy

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

Latest Information Update: 03 Jun 2025

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At a glance

  • Drugs Patritumab Deruxtecan (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERTHENA-Lung02
  • Sponsors Daiichi Sankyo Inc

Most Recent Events

  • 29 May 2025 According to Daiichi Sankyo media release, data from this study will be presented during an oral presentation (#8506) at the 2025 American Society of Clinical Oncology (ASCO25) Annual Meeting on Sunday, June 1, 2025.
  • 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States and Canada, patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial, has been voluntarily withdrawn.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.
  • 17 Sep 2024 Results published in the Merck and Co media release

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