Non-small cell lung cancer
Conditions
Brief summary
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Overall Survival (OS)
Detailed description
Incidence of Adverse Events (AE), Discontinuation Rate of Study Intervention Due to an AE, Objective Response Rate (ORR) Per RECIST 1.1 as assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as assessed by BICR, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score, Change From Baseline in Cough Using the EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Item 1 Score, Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score, Time to Deterioration (TTD) in health-related quality of life (HRQoL) Using the EORTC QLQ-C30 Items 29 and 30 Score, TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score, TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR), Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AE), Discontinuation Rate of Study Intervention Due to an AE, Objective Response Rate (ORR) Per RECIST 1.1 as assessed by BICR, Duration of Response (DOR) Per RECIST 1.1 as assessed by BICR, Change from Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score, Change From Baseline in Cough Using the EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Item 1 Score, Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score, Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score, Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score, Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score, Time to Deterioration (TTD) in health-related quality of life (HRQoL) Using the EORTC QLQ-C30 Items 29 and 30 Score, TTD in Cough Using | — |
Countries
Czechia, Estonia, France, Germany, Hungary, Italy, Latvia, Lithuania, Norway, Poland, Romania, Spain