Rationale and protocol design of a phase II study of first-line osimertinib treatment for patients with poor performance status and EGFR mutation-positive non-small cell lung cancer (OPEN/TORG2040)

BMC Cancer

Study Protocol

Akiko Kada¹  Toshiki I. Saito¹  Hiroaki Okamoto²  Satoshi Igawa³  Katsuhiko Naoki³  Tomoya Fukui³  Yoshihito Kogure⁴  Jiichiro Sasaki⁵ 

[1] Clinical Research Center, National Hospital Organization Nagoya Medical Center, Aichi, Japan;Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen’s Hospital, Kanagawa, Japan;Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, 252-0374, Sagamihara, Kanagawa, Japan;Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Aichi, Japan;Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan;

关键词: Osimertinib;    Epidermal growth factor receptor;    Non-small cell lung cancer;    Poor performance status;    First-line chemotherapy;   

DOI  :  10.1186/s12885-022-10409-6

 received in 2021-12-28, accepted in 2022-12-05,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundCancer chemotherapy indications for patients with poor performance status and advanced lung cancer are limited. Molecular targeted drugs, including epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors, can be used in patients with poor performance status owing to their high efficacy and safety. The third-generation EGFR-tyrosine kinase inhibitor osimertinib has demonstrated effectiveness in the initial treatment of advanced EGFR mutation-positive non-small cell lung cancer in patients with good performance status; however, no evidence exists of the drug’s effectiveness in patients with poor performance status in a prospective study. We designed a study that aims to investigate the efficacy and safety of first-line osimertinib treatment in patients with advanced non-small cell lung cancer harboring sensitive EGFR mutations and with poor performance status.MethodsThe OPEN/TORG2040 study is a multicenter, single-arm, phase II trial for patients with unresectable, advanced EGFR mutation-positive non-small cell lung cancer with a poor performance status (≥ 2). Eligible patients will receive osimertinib until disease progression or unacceptable toxicity. The primary endpoint is the objective response rate of the first-line osimertinib treatment. Considering a threshold value of 45%, expected value of 70% for objective response rate, one-sided significance level of 5%, statistical power of 80%, and ineligible patients, the sample size was set to 30. The secondary endpoints are disease control rate, performance status improvement rate, and safety and patient-reported outcomes using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Quality of Life Questionnaire and Lung Cancer 13. Time to treatment failure, progression-free survival, and overall survival will also be assessed.DiscussionOur study can determine the clinical benefits of osimertinib treatment in patients with poor performance status, since the clinical outcomes of patients with EGFR mutation-positive non-small cell lung cancer with poor performance status treated with this drug as a first-line treatment have not been sufficiently evaluated.Trial registrationJapan Registry of Clinical Trials: jRCTs041200100 (registration date: February 12, 2021).

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

Fig. 7