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- W3137333075 abstract "Immune check point inhibitors (ICIs) has revolutionized first-line treatment of advanced NSCLC patients. Antiangiogenic agent (e.g. anlotinib, lenvatinib) combined with ICIs have provided a promising therapeutic strategy. Our previous explanatory study suggested that anlotinib has staggering synergetic effect when combined with ICIs. Based on previous studies, we propose our hypothesis that nivolumab combined with anlotinib may confer survival benefit even in patients previously treated with ICIs because of the staggering synergetic effect, and may serve as a better second-line treatment. This is a phase Ib/IIa, open-label, single center study, aiming to investigate safety and efficacy of nivolumab (administered intravenously) in combination with anlotinib (administered orally) in immunotherapy-treated advanced NSCLC. The study has been designed to allow an investigation of the optimal combination dose and schedule while ensuring the safety of patients with intensive safety monitoring. There are two main parts to this study; Part A, combination dose finding and Parts B, dose expansion. Part B will either be initiated if recommended phase 2 dose (RP2D) reached in Part A, or not initiated if RP2D was not reached in Part A. The primary objective in part A is to define the RP2D of nivolumab combined with anlotinib, secondary objective is to investigate the safety and tolerability of nivolumab combined with anlotinib. The primary objective in part B is ORR, secondary objective is progression-free survival (PFS), disease control rate (DCR) and overall survival (OS). The study has been registered in clinicaltrial.gov and the registration number is NCT04507906. The study will recruit a total of 62 participants in September 2020 and is expected to take 35 months. We conduct a phase II study to investigate the safety and efficacy of nivolumab combined with anlotinib in advanced non-small cell lung cancer patients previously treated with checkpoint inhibitors." @default.
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- W3137333075 date "2021-03-01" @default.
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- W3137333075 title "P86.16 Rationale of a Phase II Trial of Nivolumab Combined with Anlotinib in Advanced NSCLC Previously Treated with Immunotherapy" @default.
- W3137333075 doi "https://doi.org/10.1016/j.jtho.2021.01.1245" @default.
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