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An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)

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Trial Profile

An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients With HER2-mutant Metastatic NSCLC Who Have Disease Progression on or After at Least One-line of Treatment (DESTINY-Lung05)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Dec 2024

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At a glance

  • Drugs Trastuzumab-deruxtecan (Primary)
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DESTINY-Lung05; DL-05
  • Sponsors AstraZeneca

Most Recent Events

  • 04 Dec 2024 Status changed from active, no longer recruiting to completed.
  • 14 Oct 2024 According to an AstraZeneca media release, Ying Cheng is principal investigator in this trial.
  • 14 Oct 2024 According to an AstraZeneca media release, based on results from DESTINY-Lung02 and DESTINY-Lung05 trials, the Enhertu has received conditional approval from China's NMPA as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations and who have received a prior systemic therapy. Full approval for this indication will depend on the clinical benefit from the confirmatory trial.

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