Non-Small Cell Lung Cancer
Conditions
Brief summary
Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs), Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC), OR (CR and PR) per RECIST 1.1
Detailed description
Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS), OR (CR and PR), DC, DOR, TTR, PFS, Overall survival (OS), Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs, PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC, Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response (OR) (complete response [CR] and partial response [PR]) measured by computed tomography (CT) or Magnetic resonance imaging (MRI) and assessed per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), Incidence of treatment-emergent adverse events (TEAEs), grade ≥ 3 TEAEs, Serious Adverse Events (SAEs), and Events of Interest (EOIs), Pharmacokinetic (PK) parameters of AMG 193 including, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), and area under the concentration-time curve (AUC), OR (CR and PR) per RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control (DC), Duration of response (DOR), Time to response (TTR), Progression free survival (PFS), OR (CR and PR), DC, DOR, TTR, PFS, Overall survival (OS), Incidence and severity of TEAEs, grade ≥ 3 TEAEs, SAEs, and EOIs, PK parameters of AMG 193 including, but not limited to Cmax, Tmax, and AUC, Changes in cancer-specific symptoms, treatment-related symptom and overall health status using subject-reported outcome instruments: o EORTC QLQ-C30 o QLQ LC13 o EQ-5D-5L o PRO-CTCAE o GP5 of FACT-G | — |
Countries
Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Latvia, Netherlands, Poland, Portugal, Spain