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A Phase 1/2 Study Of Pegzilarginase (AEB1102, Co-Argi-PEG) In Combination With Pembrolizumab In The Treatment Of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)
The main purpose of this Phase 1/2 study is to determine the safety and efficacy of pegzilarginase in combination with pembrolizumab in patients with ED-SCLC who have relapsed or progressive disease on or within 6 months of platinum-based chemotherapy.
Primary Objective: Phase 2: To determine (using a Simon 2-stage minimax design) the objective response rate (ORR: CR+PR) by RECIST 1.1 of pegzilarginase in combination with pembrolizumab. Secondary Objectives: * To determine the ORR by iRECIST 1.1 of pegzilarginase in combination with pembrolizumab. * To determine the following additional efficacy endpoints by both RECIST 1.1 and iRECIST: o Clinical benefit rate (CR + PR + SD lasting at least 8 weeks) o Time to response o Duration of response o Progression-free survival * To describe overall survival * To evaluate the safety profile of the combination of pegzilarginase with pembrolizumab in the study patient population (Phase 2)
> 1. Patient is > 18 years of age and able and willing to provide written informed consent
> 1. Has received more than 2 platinum-based regimens against SCLC