Spots Global Cancer Trial Database for Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC
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Trial Identification
Brief Title: Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC
Official Title: Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC
Study ID: NCT03300115
Conditions
Interventions
Study Description
Brief Summary: The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety.
Detailed Description: The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand the sample size based on the fixed dose recommended by the results of previous dose exploration studies in order to further evaluate the study drug's efficacy and safety with overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and further evaluate subjects' duration of response (DOR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety indicators of subjects are further evaluated through adverse events, vital signs and clinical laboratory parameters.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, Beijing, China
Chinese PLA General Hospital, Beijing, Beijing, China
Daping Hospital,Research Institute of Surgery Third Military Medical University, Chongqing, Chongqing, China
Fujian Cancer Hospital, Fuzhou, Fujian, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Medical College of HUST, Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University, Changsha, Hunan, China
Xiangya Hospital Central South University, Changsha, Hunan, China
The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China
Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China
Jilin Cancer Hospital, Chang chun, Jilin, China
The First Hospital of Jilin University, Changchun, Jilin, China
Shandong Cancer Hospital, Jinan, Shandong, China
Tangdu Hospital, Xi'an, Shanxi, China
West China Hospital, Sichuan University, Chengdu, Sichuan, China
Tianjin Cancer Hospital, Tianjin, Tianjin, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Hangzhou First People's Hospital, Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital,Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Contact Details
Name: Yilong Wu, MD
Affiliation: Guangdong Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR
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