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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: 24 Nov 2025

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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

  • 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.
  • 24 Jun 2025 According to AstraZeneca media release,based on results from a subgroup analysis of the TROPION-Lung05 and supported by data from the TROPION-Lung01,DATROWAY has been approved in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
  • 23 Jun 2025 According to Daiichi Sankyo media release, based on subgroup results from the this and TROPION-Lung05 phase 2 trials the U.S. FDA has approved Priority Review and Breakthrough Therapy Designation.

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