C6461004 - A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER

Condition studied

Extensive-Stage Small Cell Lung Cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Phase 2: • Confirmed ORR as assessed by investigator based on RECIST v1.1 • AEs as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study intervention., Phase 3: • OS

Endpoint detail

Phase 2 • DOR as assessed by investigator based on RECIST v1.1 • PFS as assessed by investigator based on RECIST v1.1 • OS, Phase 2 • Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing. • DLTs, Phase 2 • Predose and postdose concentrations of PF 08634404., Phase 2 • Incidence of ADA against PF-08634404., Phase 3 • PFS using RECIST v1.1 as assessed by BICR, Phase 3 • Confirmed ORR using RECIST v1.1 as assessed by BICR • Confirmed ORR using RECIST v1.1 as assessed by investigator, Phase 3 • PFS using RECIST v1.1 as assessed by investigator, Phase 3 • DOR using RECIST v1.1 as assessed by BICR • DOR using RECIST v1.1 as assessed by investigator, Phase 3 • AEs as characterized by type, frequency, intensity as graded by NCI CTCAE version 5.0, timing, seriousness, and relationship to study intervention(s)., Phase 3 • Laboratory test abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0) and timing., Phase 3 • Predose and postdose concentrations of PF 08634404., Phase 3 • Incidence of ADA against PF 08634404., Phase 3 • Mean scores and change from baseline in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30 • Mean scores and change from baseline on the EORTC QLQ-LC13 • Time to definitive deterioration in the global health status/QoL, function, and symptom scores on the EORTC QLQ-C30 • Time to definitive deterioration in dyspnea, cough, or chest pain on the EORTC QLQ-LC13