NCT04146571

Expanded Access to Ensartinib for Participants With ALK+ NSCLC

Expanded Access Intermediate-Size Patient Population Protocol

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Xcovery Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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)

Conditions

• Non-Small Cell Lung Cancer
• ALK Gene Rearrangement Positive

Interventions

Type	Name	Description
DRUG	Ensartinib	Oral, ALK inhibitor

Timeline

• First posted: 2019-10-31
• Last updated: 2022-10-20

Locations

4 sites across 1 country: United States