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Protocol No. UW16148

Principal Investigator Leal, Ticiana

Phase III

Age Group Adult

Scope National

Sponsor Type Industry

Title eXALT3: Phase 3 Randomized Study Comparing Ensartinib to Crizotinib in Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Patients

Objective This research study is being done to evaluate the efficacy and safety of an investigational drug, X-396,(Ensartinib) compared to crizotinib, the standard treatment for patients with the type of cancer that you have. "Investigational" means that X-396 has not been approved by the United States Food and Drug Administration (FDA) for use outside of clinical studies. X-396 has been evaluated in one clinical study before the study you are being asked to participate in.

Treatment Different genes have been shown to change and affect the development and growth of tumors. Based on laboratory studies, X-396 (Ensartinib) blocks the effects of at least 2 of these genes (ALK and MET), similar to crizotinib.

Description You will be randomly assigned (similar to flipping a coin) to receive either the investigational drug, X-396, (Ensartinib) or crizotinib. You have an equal chance of receiving either drug. You and your doctor do not get to choose which medication you will receive. You and your doctor will know which medication you are assigned to take. A supply of the study drug will be given to you to take home, with instructions on how and when to take the medication. You will take the study drug by mouth, once or twice every day, as instructed. You will also be told how often you will need to come back to the clinic for testing and to see how you are doing. This study will include the collection of blood to check and monitor your general health while on the study. We will also collect other blood and tumor tissue samples from you during the study.

Key Eligibility
  • 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
  • Brain metastases allowed if asymptomatic at study baseline. Patients with untreated brain metastases must not be on corticosteroids
  • Patients must have measurable disease
  • Patients that have previously received an ALK TKI, and patients currently receiving cancer therapy (i.e., other targeted therapies, chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) will be excluded
  • Patients who received any chemotherapy within 4 weeks, or major surgery or radiotherapy within the last 14 days will be excluded
  • Patients with primary CNS tumors and leptomeningeal disease will be excluded
  • Women who are pregnant or breastfeeding will be excluded
  • Patients who have active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications will be excluded

Applicable Disease Sites Lung

Therapies Involved Other

Drugs Involved X-396; crizotinib

Status Open

Participating Institutions UW Hospital and Clinics