Metastatic Non-Small Cell Lung Cancer
Conditions
Brief summary
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%
Detailed description
Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30, Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ- C30, TTD in Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30, TTD in Dyspnea Score (Item 8) on the EORTC QLQ-C30, TTD in Cough Score (Item 31) on the EORTC QLQ-LC13, TTD in Chest Pain Score (Item 40) on the EORTC QLQ-LC13, Number of Participants Who Experienced One or More Adverse Events (AEs), Number of Participants Who Discontinued Study Intervention Due to an AE, Duration of Response (DOR)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1% | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS), Progression-Free Survival (PFS), Objective Response Rate (ORR), Change from Baseline in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), Change from Baseline in Physical Functioning (Items 1-5) Combined Score on the EORTC QLQ-C30, Change from Baseline for Role Functioning (Items 6 and 7) Combined Score on the EORTC QLQ-C30, Change from Baseline in Dyspnea Score (Item 8) on the EORTC QLQ-C30, Change from Baseline in Cough Score (Item 31) on the European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13), Change from Baseline in Chest Pain Score (Item 40) on the EORTC QLQ- LC13, Time to Deterioration (TTD) in the Global Health Status/Quality of Life (Items 29 and 30) Combined Score on the EORTC QLQ-C30, TTD in Physical Functioning (Items 1-5) Combin | — |
Countries
Austria, France, Germany, Poland, Spain