Non-small cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : CH5424802(AF802)
INN of investigational material : alectinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investi
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Measured by RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics other EORTC QLQ-C30, QLQ-LC13 | — |
Countries
Japan
Outcome results
None listed