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.
Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis of pathologic criteria after complete surgical resection(R0).
Complete recovery from surgery and standard post-operative therapy (if applicable) at the time of randomization.
Confirmation by the central laboratory that the tumour harbours ALK positive.
Patients who are participating in other clinical studies or are receiving other investigational drugs , or investigational devices within 4 weeks before the first dose of our study drugs. If patients are participating in non-interventional clinical trials, they can be included in this study.
Patients who have a presence of unresectable or metastatic disease, the pathological diagnosis show the microscopically positive surgical margins or extranodal invasion, or residual disease of surgery，or had only segmentectomies or wedge resections.
Patients with superior sulcus cancer.
Patients who have received a surgery with total right lung resection.
Parallel
Ensartinib
DrugEnsartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
Placebo
DrugPlacebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.
Disease free survival (DFS)
From date of randomization until date of tumor recurrence or death, whichever occurs earlier
DFS rate at 3 years
DFS rate at 5 years
Overall survival (OS)
OS rate at 5 years
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