Non-small cell lung cancer harboring EML4-ALK
Conditions
Interventions
Crizotinib 250 mg oral administration twice per day
Sponsors
Okayama Lung Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Advanced non-small cell lung cancer confirmed by histological or cytological diagnosis. EML4-ALK fusion gene is positive. There is no treatment history with ALK inhibitors excluding alectinib. The treatment history with cytotoxic chemotherapy is unquestioned. Disease stage is III/IV period which is postoperative recurrence or unavailable for surgery or radical irradiation. Performance status (ECOG scale): 0-2
Exclusion criteria
Exclusion criteria: Patients with symptomatic brain metastases. Pregnant women, nursing mothers, the women who may be pregnant or have the will to get pregnant, and the men who hope for fertility with pregnancy. The patients with a history of hypersensitivity to crizotinib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, overall survival, expression of EML4-ALK and MET, adverse events, quality of life, and survey using the care notebook | — |
Countries
Japan
Contacts
Public ContactHideko Isozaki
Okayama University Hospital Department of Respiratory Medicine
Outcome results
None listed