XALT3: Phase 3 Randomized Study Comparing X-396 to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of X-396 vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no prior ALK inhibitor.
* Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive. Patients may have received up to 1 prior chemotherapy regimen, which may also include maintenance therapy.
* Patients must have measurable disease per RECIST v. 1.1.
* Patients must be ALK-positive by IHC.
* Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy.
* Brain metastases allowed if asymptomatic at study baseline.
Rachel Sanborn, M.D.
- Oncology and Hematology Care Eastside
- Oncology and Hematology Care Westside