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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

August 3, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

June 30, 2026

Conditions
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Interventions
DRUG

Alectinib

Alectinib capsules will be administered orally at a dose of 600 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.

DRUG

Crizotinib

Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.

Trial Locations (21)

10400

Rajavithi Hospital, Bangkok

Ramathibodi Hospital, Bangkok

90110

Songklanagarind Hospital, Songkhla

100142

Beijing Cancer Hospital, Beijing

101149

Beijing Chest Hospital, Beijing

130021

the First Hospital of Jilin University, Changchun

132013

Jilin Cancer Hospital, Changchun

150081

Harbin Medical University Cancer Hospital, Harbin

200030

Shanghai chest hospital, Shanghai

200032

Fudan University Shanghai Cancer Center, Shanghai

200433

Shanghai Pulmonary Hospital, Shanghai

210009

Jiangsu Cancer Hospital, Nanjing

310003

The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

510060

Sun Yet-sen University Cancer Center, Guangzhou

510080

Guangdong General Hospital, Guangzhou

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

03181

Kangbuk Samsung Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY