Non-small cell lung cancer (NSCLC)
Conditions
Brief summary
Objective response (OR) (OR = complete response [CR] + partial response [PR]), measured by computed tomography (CT) or magnetic resonance imaging (MRI) and assessed per RECIST 1.1 per Blinded Independent Central Review (BICR)
Detailed description
Disease control (CR + PR + stable disease [SD]), Duration of response (DOR), Time to response (TTR), Progression-free survival (PFS), Overall survival (OS), Treatment-emergent adverse events, treatment-related adverse events, and changes in vital signs, electrocardiogram [ECGs], and clinical laboratory tests., PK parameters of sotorasib including, but not limited to, maximum plasma concentration (Cmax), time to achieve Cmax (tmax), and area under the plasma concentration-time curve (AUC)
Interventions
DRUGSOTORASIB
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response (OR) (OR = complete response [CR] + partial response [PR]), measured by computed tomography (CT) or magnetic resonance imaging (MRI) and assessed per RECIST 1.1 per Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control (CR + PR + stable disease [SD]), Duration of response (DOR), Time to response (TTR), Progression-free survival (PFS), Overall survival (OS), Treatment-emergent adverse events, treatment-related adverse events, and changes in vital signs, electrocardiogram [ECGs], and clinical laboratory tests., PK parameters of sotorasib including, but not limited to, maximum plasma concentration (Cmax), time to achieve Cmax (tmax), and area under the plasma concentration-time curve (AUC) | — |
Countries
Belgium, France, Italy, Spain, Sweden
Outcome results
None listed