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. 1. David Geffen School of Medicine at UCLA, Los Angeles, CA. 2. Lungen Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany. 3. Hospital Doce de Octubre, Madrid, Spain. 4. Hospital Virgen del Rocio, Sevilla, Spain. 5. Hospital Universitario La Fe, Valencia, Spain. 6. Institut Català d'Oncologia, L'Hospitalet, Barcelona, Spain. 7. Eli Lilly and Company, Bridgewater, NJ. 8. Eli Lilly and Company, Indianapolis, IN. 9. Kinki University School of Medicine, Osaka, Japan. Electronic address: nakagawa@med.kindai.ac.jp.
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.
RCT Entities:
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 cancerpatients 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.
Authors: Manuel Cobo; Vanesa Gutiérrez; Rosa Villatoro; Jose Manuel Trigo; Inmaculada Ramos; Omar López; María Ruiz; Ana Godoy; Irene López; Macarena Arroyo Journal: Lung Cancer (Auckl) Date: 2017-07-12
Authors: Edward B Garon; Katherine B Winfree; Cliff Molife; Zhanglin Lin Cui; Edurne Arriola; Benjamin Levy; Tarek Mekhail; Maurice Pérol Journal: Support Care Cancer Date: 2020-04-21 Impact factor: 3.603