Study to Compare AMG 510 "Proposed INN Sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).

Official Title

A Phase 3 Multicentre, 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

Summary:

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Trial Description

Primary Outcome:

  • Progression-free survival (PFS)
Secondary Outcome:
  • Overall Survival (OS)
  • Objective Response Rate (ORR)
  • Patient Reported Outcomes (PRO)
  • Quality of Life Assessment
  • Duration of response (DOR)
  • Time to response (TTR)
  • Disease control rate (DCR)
  • Number of subjects with Clinically significant changes in vital signs
  • Number of subjects with treatment-emergent adverse events
  • Number of subjects with Clinically significant changes in Laboratory tests
  • Number of Subjects with treatment-related adverse events
  • Maximum plasma concentration (Cmax)
  • Area under the plasma concentration-time curve (AUC)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society