Treatment Rationale and Study Design for the RELAY Study: A Multicenter, Randomized, Double-Blind Study of Erlotinib With Ramucirumab or Placebo in Patients With Epidermal Growth Factor Receptor Mutation-Positive Metastatic Non-Small-Cell Lung Cancer

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• 作者：Edward B. Garon¹ ; Martin Reck² ; Luis Paz-Ares³ ; Santiago Ponce³ ; Jesus Corral Jaime⁴ ; Oscar Juan⁵ ; Ernest Nadal⁶ ; Pablo Lee⁷ ; Rita Dalal⁷ ; Jingyi Liu⁸ ; Shuang He⁸ ; Joseph Treat⁸ ; Kazuhiko Nakagawa⁹ ; ^{nakagawa@med.kindai.ac.jp}
• 关键词：Epidermal growth factor receptor mutation ; Erlotinib ; Non-small cell lung cancer ; Ramucirumab ; RELAY trial
• 刊名：Clinical Lung Cancer
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：18
• 期：1
• 页码：96-99
• 全文大小：266 K
• 卷排序：18

文摘

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 MethodsThe 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.ConclusionErlotinib 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.