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A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)

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A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 Jul 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary)
  • Indications Adenocarcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Lung01
  • Sponsors Daiichi Sankyo Inc

    • Most Recent Events

    • 24 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 06 Apr 2024 According to Daiichi Sankyo Company Media Release, as part of Project Orbis, ENHERTU also is under regulatory review for the same indication by regulatory authorities in Australia, Brazil and Singapore.
    • 06 Apr 2024 According to Daiichi Sankyo Company Media Release, ENHERTU has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on DESTINY-PanTumor02, DESTINY-Lung01 or DESTINY-CRC02, contingent upon verification and description of clinical benefit in a confirmatory trial.

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