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

Edward B. Garon, Martin Reck, Luis Paz-Ares, Santiago Ponce, Jesus Corral Jaime, Oscar Juan, Ernest Nadal, Pablo Lee, Rita Dalal, Jingyi Liu, Shuang He, Joseph Treat, Kazuhiko Nakagawa

Research output: Contribution to journalArticlepeer-review

11 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)96-99
Number of pages4
JournalClinical Lung Cancer
Volume18
Issue number1
DOIs
StatePublished - Jan 1 2017

Keywords

  • Epidermal growth factor receptor mutation
  • Erlotinib
  • Non-small cell lung cancer
  • RELAY trial
  • Ramucirumab

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