metastatic non-small cell lung cancer
Conditions
Brief summary
Phase 2: Progression free survival (PFS) by RECIST v1.1, Phase 3: Progression free survival (PFS) by RECIST v1.1, Phase 3: overall survival (OS).
Detailed description
Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1, Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1, Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Progression free survival (PFS) by RECIST v1.1, Phase 3: Progression free survival (PFS) by RECIST v1.1, Phase 3: overall survival (OS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1, Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1, Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities | — |
Countries
Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden