Portal de investigación
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
Autores de IIS La Fe
Participantes ajenos a IIS La Fe
- Garon, EB
- Reck, M
- Paz-Ares, L
- Ponce, S
- Jaime, JC
- Nadal, E
- Lee, P
- Dalal, R
- Liu, JY
- He, S
- Treat, J
- Nakagawa, K
Grupos
Abstract
Introduction: We present the treatment rationale and study design for the RELAY study (NCT02411448). This phase lb/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 lb), 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. (C) 2016 Elsevier Inc. All rights reserved.
Datos de la publicación
- ISSN/ISSNe:
- 1525-7304, 1938-0690
- Tipo:
- Article
- Páginas:
- 96-99
- PubMed:
- 27894601
- Factor de Impacto:
- 1,597 SCImago ℠
- Cuartil:
- Q1 SCImago ℠
Clinical Lung Cancer CIG MEDIA GROUP, LP
Citas Recibidas en Web of Science: 9
Documentos
- No hay documentos
Filiaciones
Keywords
- Epidermal growth factor receptor mutation; Erlotinib; Non-small cell lung cancer; Ramucirumab; RELAY trial
Campos de Estudio
Cita
Garon EB,Reck M,Paz L,Ponce S,Jaime JC,JUAN O,Nadal E,Lee P,Dalal R,Liu JY,He S,Treat J,Nakagawa K. 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. Clin. Lung Cancer. 2017. 18. (1):p. 96-99. IF:4,204. (2).