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A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

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Trial Profile

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 May 2025

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At a glance

  • Drugs Datopotamab deruxtecan (Primary) ; Rilvegostomig (Primary) ; Carboplatin; Cisplatin; Etoposide; Pemetrexed; Tegafur/uracil; Vinorelbine
  • Indications Adenocarcinoma; Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TROPION-Lung12
  • Sponsors AstraZeneca

Most Recent Events

  • 13 Feb 2025 Planned primary completion date changed from 21 Oct 2031 to 19 May 2033.
  • 18 Nov 2024 According to a GRAIL, Inc media release, the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study
  • 18 Nov 2024 Planned End Date changed from 1 Feb 2035 to 19 Jan 2035.

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