Clinical Trial

Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

Recruiting Phase 3
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Record status
This record was last updated August 23, 2024 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-04-18; most recent amendment 2024-08-21.
Status change: Not Yet Recruiting → Recruiting 2022-07-13
Trial Details
NCT Number NCT05341583
Lead Sponsor Betta Pharmaceuticals Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 202 participants
Start Date 2022-05-24
Primary Completion 2025-06-01 (estimated)
Study Completion 2025-07-23 (estimated)
Updated on ClinicalTrials.gov 2024-08-23