This randomized, active-controlled, multicenter, open-label, Phase II study is designed to evaluate the efficacy and safety of ensatinib compared with Platinum-Based Chemotherapy as adjuvant treatment in ALK fusion positive II-IIIA stage non-small cell lung cancer after surgical resection
Surgical resection of histologically confirmed Stage IIA to IIIA NSCLC with negative margins, ,within 10 weeks after the operation
Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS
Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
At least 3-months life expectancy
More than 10 weeks before surgery Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
Use of other investigational drug within 4 weeks prior to the first dose of Ensartinib
Prior stem cell or organ transplant
severe cardiovascular disease
Sichuan University
Lead sponsor
Betta Pharmaceuticals Co., Ltd.
Collaborator