Recruitment Complete
Sponsor ID
20190009
Study to Compare AMG 510 "proposed INN sotorasib" With Docetaxel in Non Small Cell Lung Cancer (NSCLC) (CodeBreak 200).
Study Details
A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation
Protocol Summary
Primary Outcome Measures
Progression-free survival (PFS)
Timeframe: Baseline to approximately 6 years
Secondary Outcome Measures
Overall Survival (OS)
Timeframe: Baseline to approximately 6 years
Objective Response Rate (ORR)
Timeframe: Baseline to approximately 6 years
Patient Reported Outcomes (PRO)
Timeframe: Baseline to week 12
Quality of Life Assessment
Timeframe: Baseline to week 12
Duration of response (DOR)
Timeframe: Baseline to approximately 6 years
Time to response (TTR)
Timeframe: Baseline to approximately 6 years
Disease control rate (DCR)
Timeframe: Baseline to approximately 6 years
Number of subjects with Clinically significant changes in vital signs
Timeframe: Approximately 1 year
Number of subjects with treatment-emergent adverse events
Timeframe: Estimated up to approximately 6 years
Number of subjects with Clinically significant changes in Laboratory tests
Timeframe: Estimated up to approximately 1 year
Number of Subjects with treatment-related adverse events
Timeframe: Estimated up to 6 years
Maximum plasma concentration (Cmax)
Timeframe: Estimated up to 4 months
Area under the plasma concentration-time curve (AUC)
Timeframe: Estimated up to 4 months
Locations
Location
Centre Hospitalier Universitaire de Liege
Liege, Belgium, 4000
Status
Recruiting
Location
Metropolitan Hospital
Athens, Greece, 18547
Status
Recruiting
Location
Nederlands Kanker Instituut Antoni van Leeuwenhoekziekenhuis
Amsterdam, Netherlands, 1066 CX
Status
Recruiting
Location
Center for Oncology Clinical Trials
Grand Rapids, MI, United States, 49503
Status
Recruiting
Location
Miyagi Cancer Center
Natori-shi, Miyagi, Japan, 981-1293
Status
Recruiting
Location
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Status
Recruiting
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