Phase II, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
This study is designed to identify the target NSCLC population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second-line or third-line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).
Primary:The primary objective is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ NSCLC.
Secondary: The secondary objectives are to determine: Duration of response (DoR), Disease control rate (DCR), Duration of disease control (DDC), Progression free survival (PFS), Overall survival (OS), Safety and tolerability.
Exploratory: The exploratory objectives are to: Correlate c-Met expression level (nucleic acid and protein) in tumor and plasma (ctDNA) with ORR and DoR, To explore the relationship between pharmacokinetic (PK) and pharmacodynamic (PDx), safety, and efficacy endpoints. To evaluate other predictive biomarkers that correlate with efficacy and safety. To assess the following patient reported outcomes (PROs): European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Core 15 Palliative (EORTC QLQ-C15-PAL) EORTC QLQ Lung Cancer (EORTC QLQ-LC13) EORTC QLQ Chemotherapy-induced Peripheral Neuropathy (EORTC QLQ-CIPN20) EuroQoL EQ-5D-5L.