Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced NSCLC (DUBLIN-3)
|
|
文献详情
编号/登记号：
注册时间：
研究开始时间：
研究结束时间：
项目类型：
本院角色：
多中心研究：
招募状态：
试验分期：
研究疾病/适应症：
研究类型：
研究单位：[1]BeyondSpring Pharmaceuticals Inc.[2]Pacific Cancer Medical Center, Inc. Anaheim, California, United States, 92801[3]Innovative Clinical Research Institute Whittier, California, United States, 90603[4]Memorial Health Care System Colorado Springs, Colorado, United States, 80909[5]Cancer Center of Central Connecticut Plainville, Connecticut, United States, 06062[6]Peachtree Hematoloy-Oncology Consultants, PC Atlanta, Georgia, United States, 30318[7]Orchard Healthcare Research Inc. Skokie, Illinois, United States, 60077[8]Carle Cancer Center Urbana, Illinois, United States, 61801[9]Kansas University Medical Center Westwood, Kansas, United States, 00913[10]University of Louisville-Brown Cancer Center Louisville, Kentucky, United States, 40202[11]Henry Ford Hospital Detroit, Michigan, United States, 48202[12]Michigan Center of Medical Research Farmington Hills, Michigan, United States, 48334[13]Hattiesburg Clinic Hematology/Oncology Hattiesburg, Mississippi, United States, 39401[14]Central Care Cancer Center Bolivar, Missouri, United States, 65613[15]Wake Forest Baptist Health Winston-Salem, North Carolina, United States, 27157[16]University of Cincinnati Cincinnati, Ohio, United States, 45267[17]Toledo Cancer Center Toledo, Ohio, United States, 43623[18]Allegheny Health Network Pittsburgh, Pennsylvania, United States, 15212[19]Cookeville Regional Medical Center Cancer Center Cookeville, Tennessee, United States, 61801[20]Blacktown Cancer Centre Blacktown, New South Wales, Australia, 2148[21]Border Medical Oncology Research Unit East Albury, New South Wales, Australia, 2640[22]Gosford Hospital Gosford, New South Wales, Australia, 2250[23]Adult Mater Hospital South Brisbane, Queensland, Australia, 4101[24]Peninsula and South East Oncology Melbourne, Victoria, Australia, 3199[25]Epworth Hospital Richmond, Victoria, Australia, 3121[26]Fiona Stanley Hospital Murdoch, Western Australia, Australia, 6150[27]Perth Oncology/Mount Hospital Perth, Western Australia, Australia, 6000[28]St John of God Hospital, Subiaco Subiaco, Western Australia, Australia, 6008[29]Anhui Provincial Hospital Hefei, Anhui, China, 230000[30]Cancer Hospital Chinese Academy of Medical Science Beijing, Beijing, China, 100021[31]Beijing Cancer Hospital Beijing, Beijing, China, 100142[32]The PLA General Hospital Beijing, Beijing, China, 100853[33]The First Affiliated Hospital of Xiamen University Xiamen, Fujian, China, 361000[34]Zhongshan Hospital Xiamen University Xiamen, Fujian, China, 361000[35]Guizhou Provincial Hospital Guiyang, Guizhou, China, 550002[36]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 050011河北医科大学第四医院[37]Affiliated Cancer Hospital of Harbin Medical Unive Ha'erbin, Heilongjiang, China, 150040[38]Henan Cancer Hospital Zhengzhou, Henan, China, 450008[39]The Second Xiangya Hospital of Central South Unive Changsha, Hunan, China, 410011[40]Jiangyin People's Hospital Jiangyin, Jiangsu, China, 214400[41]Jiangsu Cancer Hospital Nanjing, Jiangsu, China, 210009[42]Nantong Tumor Hospital Nantong, Jiangsu, China, 226361[43]Jiangxi Provincial Tumor Hospital Nanchang, Jiangxi, China, 330000[44]Jilin Province Cancer Hospital Changchun, Jilin, China, 100013[45]Liaoning Cancer Hospital & Institute Shenyang, Liaoning, China, 110042[46]The First Affiliated Hospital of Xi'an Jiaotong U Xi'an, Shaanxi, China, 710061[47]Shandong Cancer Hospital Jinan, Shangdong, China, 250117[48]527-Linyi Cancer Hospital Linyi, Shangdong, China, 276000[49]Yantai Yuhuangding Hospital Yantai, Shangdong, China, 264000[50]Shanghai Chest Hospital, Shanghai Jiaotong Univers Shanghai, Shanghai, China, 200030[51]The Fifth People's Hospital of Shanghai Shanghai, Shanghai, China, 200240[52]West China Hospital of Sichuan University Chendu, Sichuan, China, 610041[53]Tianjin People's Hospital Tianjin, Tianjin, China, 300060[54]Affiliated Tumor Hospital of Xinjiang Medical Univ Ürümqi, Xinjiang, China, 830011[55]Sir Run Run Shaw Hospital, Zhejiang University Hangzhou, Zhejiang, China, 310016[56]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[57]The First Affiliated Hospital, Zhejiang University Hanzhou, Zhejiang, China, 310003[58]Ironwood Cancer & Research Centers Chandler, Arizona, United States, 85224
研究目的：
To compare the overall survival of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
Secondary purposes of the study are:
To compare overall response rate (ORR) of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
To compare progression free survival (PFS) of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
To compare incidence of Grade 4 neutropenia (absolute neutrophil count [ANC] < 0.5 × 109/L) on Day 8 (+/- 1 day) of Cycle 1 of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
To compare 24-month and 36-month OS rate of NSCLC patients receiving 2nd- or 3rd-line systemic therapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D5W) (D Arm) for advanced or metastatic disease.
