A Phase III Open-Label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-Small Cell Lung Cancer That Has Progressed After a Platinum-Containing Doublet

简要总结

主要结局

次要结局

• Progression-Free Survival (PFS) Time in Full Analysis Set Population(Time from date of randomization up to 907 days)
• Progression-Free Survival (PFS) Time in PD-L1+ Full Analysis Set Population(Time from date of randomization up to 907 days)
• Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in Full Analysis Set Population(Time from date of randomization up to 907 days)
• Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Composite Index Score at End of Treatment (EOT)(Baseline, End of treatment visit (up to Week 124))
• Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT)(Baseline, End of treatment visit (up to Week 124))
• Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity(Time from date of randomization up to 1420 days)
• Overall Survival (OS) Time in Full Analysis Set Population(Time from date of randomization up to 1420 days)
• Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population(Time from date of randomization up to 907 days)
• Percentage of Participants With Objective Response as Assessed by Independent Endpoint Review Committee (IERC) in PD-L1+ Full Analysis Set Population(Time from date of randomization up to 907 days)
• Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance: Baseline Score vs. Worst Post-baseline Score(Time from date of randomization up to 1420 days)
• Number of Participants With Confirmed Best Overall Response (BOR) as Assessed by an Independent Endpoint Review Committee (IERC) in Full Analysis Set Population(Time from date of randomization up to 907 days)
• Change From Baseline in European Quality of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire Through Visual Analogue Scale (VAS) at End of Treatment (EOT)(Baseline, End of treatment visit (up to Week 124))
• Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT)(Baseline, End of treatment visit (up to Week 124))
• Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), Drug Related Treatment Emergent Adverse Events and Treatment Emergent Adverse Events Leading to Death(Time from date of randomization up to 1420 days)
• Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) for Avelumab(Time from date of randomization up to 1420 days)