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

Inclusion Criteria:

• 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 basisof 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:

1. Absolute neutrophil count ≥ 1.5 x 109/L , Platelets ≥ 100 x 109/L ，hemoglobin ≥9g/dL

2. Total bilirubin≤ 1.5 x institutional upper limit of normal,AST and ALT≤ 2.5 xinstitutional upper limit of normal

3. Creatinine≤ 1.5 x institutional upper limit of normal ,if not, CreatinineClearance ≥ 50 ml/min

4. International normalized ratio (INR) and prothrombin time ≤1.5 x institutionalupper limit of normal; and activated partial thromboplastin time (aPTT) ≤1.5 xinstitutional upper limit of normal

• Female patients must have a negative pregnancy test at baseline.

Exclusion Criteria:

• Patients who are participating in other clinical studies or are receiving otherinvestigational drugs , or investigational devices within 4 weeks before the firstdose of our study drugs. If patients are participating in non-interventionalclinical trials, they can be included in this study.

• Patients who have a presence of unresectable or metastatic disease, the pathologicaldiagnosis 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.

• History of other malignancies within 5 years of the first dose of the study drug,except: malignant tumors that can be expected to recover after treatment.

• Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy,radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitorstargeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.),immunotherapy, investigational therapy, etc. but except platinum based chemotherapyfor adjuvant therapy.

• Major surgery within 3 weeks of the first dose of the study drug.

• Patients who have used traditional Chinese medicines and traditional Chinesemedicine preparations with indications for anti-tumor therapy or adjuvant therapyfor tumors within 14 days of the first dose of the study drug.

• Patients who have used the following drugs within 14 days before the first dose :strong inhibitors, strong inducers of CYP3A or CYP3A substrates with a narrowtherapeutic index.

• Patients who have severe cardiovascular disease.

• Patients with a known allergy to Tartrazine，a dye used in 100mg capsules.

• Severe active infection, interstitial lung disease/pneumonitis, or any seriousunderlying disease that may interfere with the subject's treatment with the regimenwithin 2 weeks prior to the first dose of study drug.

• Active HIV virus antibody,Treponema pallidum antibody positive.

• Active hepatitis B, hepatitis C virus antibody positive, or active tuberculosis.

• Presence of active gastrointestinal (GI) disease or other conditions that willinterfere significantly with the absorption, distribution, metabolism, or excretionof study drugs.

• According to the judgment of the investigator, other conditions may affect thecompliance of the protocol or affect the subject's signing of the informed consent,or is not suitable for participating in this clinical trial.