Nonsquamous non-small cell lung cancer
Conditions
Brief summary
Part 1 (Dose-Finding): Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to dose-modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2 (Randomized): Progression-free survival (PFS), defined as time from randomization to the date of first documented radiological progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause
Detailed description
Part 1: ORR; DoR; percent CTS from baseline; DCR, PFS, OS., Part 2: Incidence and frequency of AEs, SAEs, and AEs leading to dose modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2: ORR; DoR; percent CTS from baseline; DCR; OS., Part 2: Time to definitive deterioration in global health status/quality of life (QoL), shortness of breath and pain per EORTC QLQ-C30 questionnaire. Please refer to Protocol for other secondary endpoints.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 (Dose-Finding): Incidence of adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), AEs leading to dose-modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2 (Randomized): Progression-free survival (PFS), defined as time from randomization to the date of first documented radiological progression using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: ORR; DoR; percent CTS from baseline; DCR, PFS, OS., Part 2: Incidence and frequency of AEs, SAEs, and AEs leading to dose modifications or discontinuation, deaths, and clinically significant laboratory abnormalities., Part 2: ORR; DoR; percent CTS from baseline; DCR; OS., Part 2: Time to definitive deterioration in global health status/quality of life (QoL), shortness of breath and pain per EORTC QLQ-C30 questionnaire. Please refer to Protocol for other secondary endpoints. | — |
Countries
Belgium, Czechia, France, Germany, Italy, Spain