埃罗替尼
催眠药
医学
内科学
肿瘤科
表皮生长因子受体
耐受性
临床终点
安慰剂
临床研究阶段
随机对照试验
临床试验
不利影响
癌症
病理
替代医学
作者
Edward B. Garon,Martin Reck,Luis Paz‐Ares,Santiago Ponce,Jesús Corral Jaime,Óscar Juan,Ernest Nadal,Pablo Lee,Rita P. Dalal,Jingyi Liu,Song He,Joseph Treat,Kazuhiko Nakagawa
标识
DOI:10.1016/j.cllc.2016.05.023
摘要
Introduction We present the treatment rationale and study design for the RELAY study (NCT02411448 ). This phase Ib/III study will assess safety, tolerability, and efficacy of the combination of ramucirumab with erlotinib in previously untreated stage IV non–small-cell lung cancer patients with an activating epidermal growth factor receptor (EGFR) mutation. Patients and Methods The study is being conducted in approximately 120 sites in North America, Europe, and Asia and is currently open for enrollment. In part A (phase Ib), approximately 12 patients will receive ramucirumab (10 mg/kg) every 2 weeks with erlotinib (150 mg) every day. Dose-limiting toxicity will be assessed during 2 cycles (4 weeks) of treatment. In part B (phase III), approximately 450 patients will be randomized in a 1:1 ratio to receive ramucirumab or placebo every 2 weeks with erlotinib daily until disease progression, unacceptable toxicity, or other withdrawal criteria are met. The primary end point is progression-free survival, on the basis of investigator assessment. Secondary end points include overall survival, objective response rate, disease control rate, duration of response, safety, and quality of life. Conclusion Erlotinib with ramucirumab combination was chosen because the addition of an antiangiogenic agent, such as ramucirumab, would further improve the efficacy of erlotinib, which is a standard of care in the first-line treatment of patients with activating EGFR mutations.
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