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Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

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Trial Profile

Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Docetaxel
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Pharmacogenomic; Registrational; Therapeutic Use
  • Acronyms TROPION-LUNG01
  • Sponsors Daiichi Sankyo Inc
  • Most Recent Events

    • 09 Apr 2024 Planned primary completion date changed from 1 May 2024 to 10 May 2024.
    • 02 Apr 2024 Planned primary completion date changed from 29 Feb 2024 to 1 May 2024.
    • 04 Mar 2024 According to a Daiichi Sankyo Media Release, the European Medicines Agency (EMA) has validated MAA for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment. The validations confirm the completion of the applications and commence the scientific review process by the EMA's Committee for Medicinal Products for Human Use.
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