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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: 27 Jun 2024

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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

    • 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.
    • 22 Dec 2023 According to a Daiichi Sankyo Company media release, the U.S. Food and Drug Administration has accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is June 26, 2024.
    • 22 Nov 2023 This trial has been completed in Austria, according to the European Clinical Trials Database record.
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