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♦Basic information
JapicCTI-No. JapicCTI-132316
♦Title of the study
Title of the study Open-label randomized PhaseIII Study of the Efficacy and Safety of CH5424802(AF802) in ALK-Positive Advanced or Recurrent Non-Small Cell Lung Cancer with Crizotinib control
Public title of the study J-ALEX study
Primary sponsor Chugai Pharmaceutical Co., Ltd.
Secondary sponsor  
Study Type interventional (drug)
Summary To demonstrate superiority in progression-free survival (PFS) with CH5424802(Alectinib) compared with Crizotinib in previously untreated patients or patients received one line of chemotherapy, based on independent review facility(IRF)
♦Details of the study
Disease or condition Non-small cell lung cancer
Intervention
Intervention name CH5424802(AF802)
Classification name(code) of the intervention 429 (other antitumor agents)
Dosage And administration of the intervention 300mg b.i.d. (PO)
Control intervention name(code)/td> Crizotinib
Classification name(code) of the control intervention 429 (other antitumor agents)
Dosage And administration of the control intervention 250mg b.i.d. (PO)
Objectives of the study Treatment
Study phase Phase 3
Study design Randomized, controlled, multicenter, open-labeled, phaseIII trial
Target sample size 200
Inclusion Criteria 1) ECOG PS 0-2
2) Histologically or cytologically confirmed NSCLC
3) Stage IIIB/IV or recurrence
4) ALK-positive confirmed by central IHC(*1)+FISH(*2) or central RT-PCR
5) Previously untreated patients or patients received one chemotherapy
6) At least one measurable lesion under
RECIST Version 1.1

*1 Using Histofine iAEP kit
*2 Using Vysis ALK Break Apart FISH
*IHC and/or FISH test result of the central test organization can be used instead.

AgeF     20years old or more
SexF     Both
Exclusion Criteria 1) Prior treatment with ALK inhibitors
2) Meningeal metastases or brain metastases that are symptomatic or requiring treatment
3) Pleural effusion, ascites or pericardial effusion requiring treatment
4) Concurrent or historic radiographically evident interstitial lung disease
5) Multiple cancers with a disease-free interval of less than five years
6) Pregnant or lactating women

Outcome
Primary Outcome Progression-free survival (PFS) based on independent review facility(IRF)
Timepoints Measured by RECIST v1.1
Secondary Outcome OS, ORR, PRO/HRQoL, Time to CNS progression, Safety, PK
Timepoints EORTC QLQ-C30, QLQ-LC13
Institutions No. of facilities : 44, ALK central test organization: LSI medience Corporation, SRL Inc.
Duration of the study 2013-11  `  2018-6
Study status Ongoing
recruitment status Recruiting closed - ongoing study
Region Japan
♦Secondary ID
Related ID Name  
Related ID number  
♦Related information
Name of URL  
URL address  
Description of URL  
♦Contact information
Organization Chugai Pharmaceutical Co., Ltd.
Division Clinical trials information
Contact person or e-mail address etc. clinical-trials@chugai-pharm.co.jp
Organization@(Scientific) Chugai Pharmaceutical Co., Ltd.
Division@(Scientific) Clinical trials information
Contact person or e-mail address etc.@(Scientific) clinical-trials@chugai-pharm.co.jp
♦Other
Source funded
Name of research funds
Other Post marketing clinical trial
♦History
History
This information was confirmed on 2016/11/11.
2015/10/29   revised
2015/8/27   revised
2014/11/7   revised
2014/9/18   revised
2013/12/26   revised
2013/10/30   application date