Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Registration Number
- NCT05341583
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.<br><br> - Patients must be classified post-operatively as Stage IB-IIIB(T3N2M0) on the basis<br> of pathologic criteria after complete surgical resection(R0).<br><br> - Complete recovery from surgery and standard post-operative therapy (if applicable)<br> at the time of randomization.<br><br> - Confirmation by the central laboratory that the tumour harbours ALK positive.<br><br> - At least 1-year life expectancy.<br><br> - Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.<br><br> - The laboratory test values should meet the following requirements:<br><br> 1. Absolute neutrophil count = 1.5 x 109/L , Platelets = 100 x 109/L ,hemoglobin<br> =9g/dL<br><br> 2. Total bilirubin= 1.5 x institutional upper limit of normal,AST and ALT= 2.5 x<br> institutional upper limit of normal<br><br> 3. Creatinine= 1.5 x institutional upper limit of normal ,if not, Creatinine<br> Clearance = 50 ml/min<br><br> 4. International normalized ratio (INR) and prothrombin time =1.5 x institutional<br> upper limit of normal; and activated partial thromboplastin time (aPTT) =1.5 x<br> institutional upper limit of normal<br><br> - Female patients must have a negative pregnancy test at baseline.<br><br>Exclusion Criteria:<br><br> - Patients who are participating in other clinical studies or are receiving other<br> investigational drugs , or investigational devices within 4 weeks before the first<br> dose of our study drugs. If patients are participating in non-interventional<br> clinical trials, they can be included in this study.<br><br> - Patients who have a presence of unresectable or metastatic disease, the pathological<br> diagnosis show the microscopically positive surgical margins or extranodal invasion,<br> or residual disease of surgery,or had only segmentectomies or wedge resections.<br><br> - Patients with superior sulcus cancer.<br><br> - Patients who have received a surgery with total right lung resection.<br><br> - History of other malignancies within 5 years of the first dose of the study drug,<br> except: malignant tumors that can be expected to recover after treatment.<br><br> - Prior treatment with other anti-cancer treatments or NSCLC including chemotherapy,<br> radiotherapy, targeted therapy (such as small molecule tyrosine kinase inhibitors<br> targeting EGFR, VEGFR or other pathways, monoclonal antibodies, etc.),<br> immunotherapy, investigational therapy, etc. but except platinum based chemotherapy<br> for adjuvant therapy.<br><br> - Major surgery within 3 weeks of the first dose of the study drug.<br><br> - Patients who have used traditional Chinese medicines and traditional Chinese<br> medicine preparations with indications for anti-tumor therapy or adjuvant therapy<br> for tumors within 14 days of the first dose of the study drug.<br><br> - Patients who have used the following drugs within 14 days before the first dose :<br> strong inhibitors, strong inducers of CYP3A or CYP3A substrates with a narrow<br> therapeutic index.<br><br> - Patients who have severe cardiovascular disease.<br><br> - Patients with a known allergy to Tartrazine,a dye used in 100mg capsules.<br><br> - Severe active infection, interstitial lung disease/pneumonitis, or any serious<br> underlying disease that may interfere with the subject's treatment with the regimen<br> within 2 weeks prior to the first dose of study drug.<br><br> - Active HIV virus antibody,Treponema pallidum antibody positive.<br><br> - Active hepatitis B, hepatitis C virus antibody positive, or active tuberculosis.<br><br> - Presence of active gastrointestinal (GI) disease or other conditions that will<br> interfere significantly with the absorption, distribution, metabolism, or excretion<br> of study drugs.<br><br> - According to the judgment of the investigator, other conditions may affect the<br> compliance of the protocol or affect the subject's signing of the informed consent,<br> or is not suitable for participating in this clinical trial.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease free survival (DFS)
- Secondary Outcome Measures
Name Time Method DFS rate at 3 years;DFS rate at 5 years;Overall survival (OS);OS rate at 5 years