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Clinical lung cancer v.19 no.1, 2018년, pp.e5 - e9   SCIE
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Treatment Rationale and Design for J-SONIC: A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non–Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis

Otsubo, Kohei (Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan ) ; Kishimoto, Junji (Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University, Fukuoka, Japan ) ; Kenmotsu, Hirotsugu (Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho, Sunto-gun, Japan ) ; Minegishi, Yuji (Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan ) ; Ichihara, Eiki (Department of Hematology, Oncology, and Respiratory Medicine, Okayama University Hospital, Okayama, Japan ) ; Shiraki, Akira (Department of Respiratory Medicine, Ogaki Municipal Hospital, Gifu, Japan ) ; Kato, Terufumi (Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan ) ; Atagi, Shinji (Department of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan ) ; Horinouchi, Hidehito (Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan ) ; Ando, Masahiko (Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan ) ; Kondoh, Yasuhiro ; Kusumoto, Masahiko ; Ichikado, Kazuya ; Yamamoto, Nobuyuki ; Nakanishi, Yoichi ; Okamoto, Isamu ;
  • 초록  

    Abstract We describe the treatment rationale and procedure for a randomized study (J-SONIC; University Hospital Medical Information Network Clinical Trials Registry identification no., UMIN000026799) of carboplatin plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) with or without nintedanib for patients with advanced non–small cell lung cancer (NSCLC) and idiopathic pulmonary fibrosis (IPF). The study was designed to examine the efficacy and safety of nintedanib administered with carboplatin plus nab-paclitaxel versus carboplatin plus nab-paclitaxel alone in chemotherapy-naive patients with advanced NSCLC associated with IPF. Eligible patients (enrollment target, n = 170) will be randomized at a 1:1 ratio to receive 4 cycles of carboplatin (area under the curve, 6 on day 1) plus nab-paclitaxel (100 mg/m 2 on days 1, 8, and 15) administered every 3 weeks either without (arm A) or with (arm B) nintedanib (150 mg twice daily), to be followed in arm B by single-agent administration of nintedanib (150 mg twice daily). The present trial is the first randomized controlled study for the treatment of NSCLC associated with IPF. The goal of the study is to demonstrate that nintedanib combined with carboplatin plus nab-paclitaxel prolongs the interval to acute exacerbation of IPF compared with carboplatin plus nab-paclitaxel alone.


  • 주제어

    Acute exacerbation .   Chemotherapy .   IPF .   NSCLC .   Prospective study.  

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