Spots Global Cancer Trial Database for A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
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Trial Identification
Brief Title: A Clinical Trial of Fruquintinib in Patients With Advanced Non-small Cell Lung Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Clinical Trial to Evaluate the Efficacy and Safety of Fruquintinib Plus Best Supportive Care in Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Study ID: NCT02590965
Conditions
Study Description
Brief Summary: This is a randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial to evaluate the efficacy and safety of Fruquintinib plus best supportive care in patients with advanced non-squamous non-small cell lung cancer who failed to second-line standard chemotherapy.
Detailed Description: Approximately 90 subjects will be randomized to Fruquintinib plus best supportive care or placebo plus best supportive care at a 2:1 ratio. Randomization will be stratified by EGFR (epidermal growth factor receptor) gene status: mutant vs. wild type vs. unknown. All subjects will receive Fruquintinib/placebo for consecutive 3 weeks, followed by one-week rest. A treatment cycle consists of 4 weeks. Tumor assessment will be performed every 4 weeks in the first 3 cycles, and every 8 weeks since the 4th cycle, until disease progression. Further treatment and survival follow-up after progression will be recorded.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
307 Hospital of PLA, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Chest Hospital, Beijing, Beijing, China
Xi Nan Hospital, Third Military Medical University, Chongqing, Chongqing, China
Guangdong General Hospital, Guangzhou, Guangdong, China
Nantong Tumor Hospital, Nantong, Jiangsu, China
The First Hospital of Jilin University, Changchun, Jilin, China
Linyi Tumor Hospital, Linyi, Shandong, China
The Cancer Hospital of Fudan University, Shanghai, Shanghai, China
Shanghai Chest Hospital, Shanghai, Shanghai, China
West China Hospital, Chengdu, Sichuan, China
The First Affiliated Hosptial of College of Medicine, Zhejiang University, Hangzhou, Zhejiang, China
Contact Details
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