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

• Published in: Clinical lung cancer 2016
• Main Authors: Garon, Edward B., MD, Reck, Martin, MD, Paz-Ares, Luis, MD, Ponce, Santiago, MD, Jaime, Jesus Corral, MD, Juan, Oscar, MD, Nadal, Ernest, MD, Lee, Pablo, MD, Dalal, Rita, MD, Liu, Jingyi, PhD, He, Shuang, PhD, Treat, Joseph, MD, Nakagawa, Kazuhiko, MD
• Format: Article
• Language: English
• Subjects: Hematology, Oncology and Palliative Medicine; Pulmonary/Respiratory
• ISSN: 1525-7304
• DOI: 10.1016/j.cllc.2016.05.023

Abstract Introduction We present the treatment rationale and study design for the RELAY study (NCT02411448). This phase 1b/3 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 1b), 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 3), 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 endpoint is progression-free survival, based on investigator assessment. Secondary endpoints include overall survival, objective response rate, disease control rate, duration of response, safety, and quality of life. Conclusion Erlotinib plus ramucirumab combination was chosen since 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.