A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Previously Treated Extensive Stage Small Cell Lung Cancer (ESSCLC)
Primary Objectives To compare the effect of SG to SOC on ORR as assessed by BICR according to the RECIST v1.1 To compare the effect of SG to SOC on OS Secondary Objectives To compare the effect of SG to SOC on PFS as assessed by BICR according to RECIST v1.1 To compare the effect of SG to SOC on DOR as assessed by BICR according to RECIST v1.1 To compare the effect of SG to SOC on shortness of breath as assessed by the Non Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) shortness of breath domain To compare the effect of SG to SOC on physical functioning as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) physical functioning domain To compare the safety and tolerability of SG to SOC Exploratory Objectives To compare the effect of SG to SOC on progression of disease after the next line of therapy (PFS2 [progression-free survival 2]) To compare the effect of SG to SOC on CNS metastases To characterize the pharmacokinetics (PK) of SG To assess the immunogenicity of SG To compare the effect of SG to SOC on disease-related symptoms and health-related quality of life (HRQOL) as assessed by NSCLC-SAQ, EORTC QLQ-C30, the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) Pain Intensity 3a Item 1, and the EuroQol (5 dimensions, 5-levels) (EQ-5D-5L) To assess and compare the effect of SG to SOC on treatment-related symptoms using Functional Assessment of Cancer Therapy Item GP5 (FACT-Item GP5) and Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) To assess potential biomarker correlation with clinical outcomes