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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: 01 Sep 2026

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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

  • 24 Mar 2026 Planned End Date changed from 31 Jan 2026 to 15 Feb 2027.
  • 03 Feb 2026 According to Daiichi Sankyo media release, Datroway is available in the US under accelerated approval for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy based on results from the TROPION-Lung05 and TROPION-Lung01 trials.
  • 14 Aug 2025 According to Daiichi Sankyo media release, company will present data from this trial in oral presentation at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) on Monday, September 8.

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