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.

Inclusion Criteria:
• 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.

Exclusion Criteria:
• Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy.
• Brain metastases allowed if asymptomatic at study baseline.
Phase III
Rachel Sanborn, M.D.
Brenda Fisher
  • Oncology and Hematology Care Westside
  • Providence Cancer Institute Franz Clinic
  • Providence Cancer Institute Newberg Clinic