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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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Trial Profile

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: Discontinued
Phase of Trial: Phase II

Latest Information Update: 04 Nov 2025

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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 Sep 2025 ENHERTU (5.4 mg/kg) is approved in more than 10 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials.
  • 11 Sep 2025 According to Daiichi Sankyo Media release, the European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU (trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive (immunohistochemistry [IHC] 3+) unresectable or metastatic solid tumors who have received prior treatment and have no satisfactory alternative treatment options.
  • 30 May 2025 Status changed from completed to discontinued. Reason the study was stopped: Last participant transitioned to alternative study.

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