Non-small cell lung cancer
Conditions
Brief summary
1. Progression-free survival (PFS), 2. Overall survival (OS)
Detailed description
1. Objective response rate (ORR), 2. Duration of response (DOR), 3. Number of participants who experience one or more Adverse Events (AEs), 4. Number of participants who discontinue study treatment due to an AE, 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30, 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13, 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, 12. TTD in the physical functioning (items 1-5) score, on the EORTC-QLQ-C30, 13. TTD in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 14. TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30, 15. TTD in the cough (item 31) score, on the EORTC QLQ-Lung Cancer version (LC13), 16. TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival (PFS), 2. Overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective response rate (ORR), 2. Duration of response (DOR), 3. Number of participants who experience one or more Adverse Events (AEs), 4. Number of participants who discontinue study treatment due to an AE, 5. Change from baseline in global health status/quality of life (items 29 and 30) score, on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), 6. Change from baseline in the physical functioning (items 1-5) score, on the EORTC QLQ-C30, 7. Change from baseline in the role functioning (items 6-7) score, on the EORTC QLQ-C30, 8. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30, 9. Change from baseline in the cough (item 31) score, on the EORTC QLQ- LC13, 10. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13, 11. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30, 12. TTD in the physical functioni | — |
Countries
Austria, Bulgaria, France, Germany, Greece, Italy, Netherlands, Poland, Romania, Spain