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Brief Title: Expanded Access to Ensartinib for Participants With ALK+ NSCLC
Official Title: Expanded Access Intermediate-Size Patient Population Protocol
Study ID: NCT04146571
Brief Summary: This is an open-label, multicenter, intermediate-sized expanded access treatment protocol to the existing IND 111,695 for ensartinib (X-396). The treatment plan is designed to provide ensartinib to participants with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).
Detailed Description: Open-label, multi-center, intermediate-sized expanded access treatment protocol for X396-CLI-101 (Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford University, Stanford, California, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Wisconsin Carbone Cancer Ctr, Madison, Wisconsin, United States