A Phase Ⅲ, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage IB- IIIB Non-small Cell Lung Cancer.
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.
• At least 1-year life expectancy.
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
• The laboratory test values should meet the following requirements:
‣ Absolute neutrophil count ≥ 1.5 x 109/L , Platelets ≥ 100 x 109/L ，hemoglobin ≥9g/dL
⁃ Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 x institutional upper limit of normal
⁃ Creatinine≤ 1.5 x institutional upper limit of normal ,if not, Creatinine Clearance ≥ 50 ml/min
⁃ International normalized ratio (INR) and prothrombin time ≤1.5 x institutional upper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 x institutional upper limit of normal
• Female patients must have a negative pregnancy test at baseline.