Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1, Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.
Detailed description
Phase 2: PFS based on BICR assessment per RECIST version 1.1., Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1., Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1., Phase 2: Overall Survival, Phase 3: Overall Survival, Phase 3: OR based on BICR assessment per RECIST version 1.1., Phase 3: DoR based on BICR assessment per RECIST version 1.1., Phase 3: DC based on BICR assessment per RECIST version 1.1., Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30, Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13., Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Objective response (OR) based on Blinded independent central review (BICR) assessment per RECIST version 1.1, Phase 3: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2: PFS based on BICR assessment per RECIST version 1.1., Phase 2: Duration of response (DoR) based on BICR assessment per RECIST version 1.1., Phase 2: Disease control rate (DC) based on BICR assessment per RECIST version 1.1., Phase 2: Overall Survival, Phase 3: Overall Survival, Phase 3: OR based on BICR assessment per RECIST version 1.1., Phase 3: DoR based on BICR assessment per RECIST version 1.1., Phase 3: DC based on BICR assessment per RECIST version 1.1., Phase 3: Change from baseline at Week 12 in physical functioning as measured by the EORTC QLQ‑C30, Phase 3: Change from baseline at Week 12 in key lung cancer symptoms as measured by the EORTC QLQ-LC13., Phase 3: Change from baseline at Week 12 in GHS/QoL as measured by the EORTC QLQ-C30. | — |
Countries
Belgium, Italy, Portugal, Spain