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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: 09 Nov 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

  • 22 Oct 2026 According to a Daiichi Sankyo media release, Enhertu (trastuzumab deruxtecan) received conditional approval in China as monotherapy for previously treated adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumours, based on four single-arm Phase 2 trials: DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and DESTINY-PanTumor03. Full approval is subject to confirmation of clinical benefit in a confirmatory trial
  • 08 Oct 2026 According to Daiichi Sankyo Media release, an additional regulatory submission for Enhertu is underway in China for the treatment of patients with unresectable or metastatic solid tumors with HER2 expression (IHC 3+) who have received prior treatment or have no satisfactory alternative treatment options based on DESTINY-PanTumor02, DESTINY-Lung01, DESTINYCRC02 and DESTINY-PanTumor03.
  • 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.

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