ensatinib in alk-positive patients undergoing initial treatment for advanced non-small cell lung cancer

Conditions: ALK Positive; NSCLC Stage IIIB; NSCLC Stage IV

Summary: the experimental design is exploratory, single-arm, multi-center, real-world research. ensatinib 225mg qd a prospective and exploratory real-world study of ensatinib for alk-positive advanced non-small cell lung cancer patients test purposes exploring the real world, ensatinib is effective for the newly treated alk+ advanced nsclc 1. efficacy and safety; 2. the relationship between molecular mechanism and curative effect; 3. ensatinib resistance mechanism;

enrolled patients: 1. stage iiib or stage iv nsclc 2. each center confirmed alk+ by tissue samples (abbott fish, ventana alk d5f3, ngs method confirmation); 3. without any alk-tki treatment; study endpoint primary endpoint: according to the recist1.1 standard, the progression-free survival (pfs) assessed by the investigator; secondary endpoint: according to the recist1.1 standard, the objective response rate (orr) evaluated by the investigator; the time to treatment failure (ttf); according to the recist1.1 standard, the orr and pfs of patients with different alk fusion subtypes evaluated by the investigator; total lifetime (os); safety; exploratory endpoint: the correlation between the biomarkers in blood or/and tissue samples and the efficacy of ensatinib; the resistance mechanism of ensatinib; the sample size is determined: the plan is to analyze 60-80 patients with eml4-alk fusion v1 and v3 subtypes. based on the proportion of patients with both subtypes in alk-positive patients, the proportion is about 40%. based on the 20% dropout rate, the plan is to include alk without distinction. 180 patients with fusion subtype; statistical methods:

Eligibility criteria:
inclusion criteria: 1. stage iiib or stage iv nsclc by histology or cytology; 2. all centers confirmed alk positive by tissue samples (abbott fish, ventana alk d5f3, ngs method confirmation); 3. without any alk-tki treatment; 4. voluntarily and capable of following the trial and follow-up procedures; 5. able to understand the nature of the trial, and be able to complete the signing of a written informed consent form. exclusion criteria: * 1. pereceived any alk-tki treatment ; 2. received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days; 3. the investigator believes that the patient is not suitable for ensatinib treatment. had a stem cell or organ transplant. 4. having serious cardiovascular disease, including but not limited to: 5.sino - qtcf interval ≥450 ms or other significant ecg abnormalities. according to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure \>160 mmhg or diastolic blood pressure \>100mmhg). 6. dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion. 7. previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.