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)

• 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