Non-Small Cell Lung Cancer
Conditions
Interventions
Alectinib, 300 mg orally administered twice daily
Sponsors
Lung Oncology Group in Kyushu, Japan (LOGIK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic 2) Positive for ALK fusion gene by "immunohistochemistry (IHC) and fluorescence in-situ hybridisation (FISH)" or "RT-PCR" 3) ALK-TKI naive other than crizotinib 4) At least 1 measurable tumor lesion as per RECIST v1.1 5) Female or male, 20 years of age or older 6) ECOG performance status 2 to 4 7) Adequate organ function 8) Signed and dated informed consent
Exclusion criteria
Exclusion criteria: 1) known interstitial fibrosis or interstitial lung disease 2) Evidence of active malignancy 3) Brain metastasis with disordered consciousness 4) Uncontrolled Grade >/=3 SVC syndrome, pericardial effusion, pleural effusion, ascites 6) Active infectious disease 7) Concurrent radiotherapy including lung field
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate | — |
Secondary
| Measure | Time frame |
|---|---|
| PS improvement rate Safety Progression Free Survival Overall Survival | — |
Countries
Japan
Contacts
Public ContactEiji Iwama
Graduate School of Medical Sciences, Kyushu University Faculty of Medical Sciences, Department of Comprehensive Clinical Oncology
Outcome results
None listed