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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: 14 Jul 2026

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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

  • 29 Jun 2026 According to a Daiichi Sankyo media release, results from the HER2 mutant cohort were published in The New England Journal of Medicine and results from the HER2 overexpressing cohort were published in The Lancet Oncology.
  • 29 Jun 2026 According to a Daiichi Sankyo media release, the approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on results from subgroups of patients with HER2 positive (IHC 3+) tumors across three phase 2 trials, including DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.
  • 29 Jun 2026 According to AstraZeneca media release, based on results from this study Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive solid tumours who have received prior treatment and who have no satisfactory treatment options.

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