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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: 27 Jun 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

  • 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.
  • 23 May 2025 According to a Sichuan Kelun-Biotech Biopharmaceutical media release, data from this study will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting is scheduled to take place in Chicago, Illinois, USA from May 30 to June 3.

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