Spots Global Cancer Trial Database for A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
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Trial Identification
Brief Title: A Study to Evaluate and Compare the Efficacy and Safety of Alectinib Versus Crizotinib and to Evaluate the Pharmacokinetics of Alectinib in Asian Participants With Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)
Official Title: Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Asian Patients With Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
Study ID: NCT02838420
Study Description
Brief Summary: This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of alectinib versus crizotinib and to evaluate the pharmacokinetics of alectinib in asian participants with treatment-naive ALK-positive advanced NSCLC. Participants will be randomized 2:1 into one of the two treatment groups to receive either alectinib (600 milligrams \[mg\] twice daily \[BID\]) or crizotinib (250 mg BID) orally, respectively.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Cancer Hospital, Beijing, , China
Beijing Chest Hospital; Oncology Department, Beijing, , China
the First Hospital of Jilin University, Changchun, , China
Jilin Cancer Hospital, Changchun, , China
West China Hospital, Sichuan University, Chengdu, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
Guangdong General Hospital, Guangzhou, , China
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Shanghai chest hospital, Shanghai, , China
Shanghai Pulmonary Hospital, Shanghai, , China
Zhejiang Cancer Hospital, Zhejiang, , China
Kangbuk Samsung Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Songklanagarind Hospital; Department of Internal Medicine, Division of Respiratory, Songkhla, , Thailand
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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