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A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

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Trial Profile

A Phase 3 Multicenter, Randomized, Open Label, Active-controlled, Study of AMG 510 Versus Docetaxel for the Treatment of Previously Treated Locally Advanced and Unresectable or Metastatic NSCLC Subjects With Mutated KRAS p.G12C

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

Latest Information Update: 22 Jul 2025

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At a glance

  • Drugs Sotorasib (Primary) ; Docetaxel
  • Indications Non-small cell lung cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms CodeBreak 200
  • Sponsors Amgen

Most Recent Events

  • 10 Jul 2025 Planned End Date changed from 27 Apr 2026 to 25 Feb 2026.
  • 04 Feb 2025 According to an Amgen media release, Regulatory review by the EMA of the CodeBreaK 200 Phase 3 study of adults with previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC concluded with the conditional status of marketing authorization maintained.
  • 01 Oct 2024 Results reporting additional PRO outcomes with respect to the secondary and exploratory endpoints published in the Lung Cancer

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