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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: 03 Jun 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

  • 30 May 2025 Status changed from completed to discontinued. Reason the study was stopped: Last participant transitioned to alternative study.
  • 24 Apr 2025 According to Daiichi Sankyo Media release, Based on data from four phase 2 trials including HERALD,DESTINY-PanTumor02,DESTINY-CRC02 and DESTINY-Lung01,the company has submitted a supplemental New Drug Application (sNDA) to Japans Ministry of Health, Labour and Welfare (MHLW) for ENHERTU(trastuzumab deruxtecan) for the treatment of adult patients with HER2 positive advanced or recurrent solid tumors refractory or intolerant to standard treatments.
  • 24 Apr 2024 Status changed from active, no longer recruiting to completed.

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