[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ensartinib\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ensartinib":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100611032","phase-2-ensartinib-after-chemoradiotherapy-in-stage-iii-alk-mutated-nsclc-100611032",false,"NCT07235306","Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC","Ensartinib for the Treatment of Patients With ALK-Mutated Stage III Unresectable NSCLC: A Multicenter, Randomized Controlled, Double-blind Clinical Study","Inclusion Criteria:\n\n* Male or female aged at least 18 years\n* Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent\n* ALK mutations assessed by FISH, IHC, or NGS\n* ECOG Performance Status of 0 or 1\n* Completion of platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements\n* Chemoradiotherapy must have been completed ≤ 6 weeks prior to randomization\n* No disease progression during or after chemoradiotherapy\n* Life expectancy \\> 12 weeks\n* Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment\n* Signed informed consent form obtained from the patient or their legally authorized representative\n* Male and female patients of childbearing potential agree to use highly effective contraception methods from before entering the trial, throughout the study, and until 8 weeks after discontinuation of study treatment\n\nExclusion Criteria:\n\n* Mixed histology of small cell and non-small cell lung cancer\n* Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization;\n* Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria);\n* Poor cardiac function, including but not limited to any of the following:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec (obtained from 3 ECGs);\n  * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;\n  * Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concomitant use of any known drugs that prolong the QT interval and may lead to Torsades de Pointes;\n* Inadequate bone marrow reserve or organ function;\n* History of other malignant malignancies, except for adequately treated non-melanoma skin cancer or malignant lentigo, cured carcinoma in situ, or other solid tumors cured \\> 5 years ago with no evidence of disease and considered by the treating physician to have a low risk of recurrence;\n* Severe or uncontrolled systemic diseases: including uncontrolled hypertension and active bleeding tendency; or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of ensartinib;\n* Any prior chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy beyond the definitive treatment for locally advanced disease;\n* Prior treatment with any ALK tyrosine kinase inhibitor (ALK-TKI);\n* Major surgery within 4 weeks prior to the first dose of study drug;\n* Current use of medications known to be strong inducers of CYP3A4 (which cannot be discontinued at least 3 weeks prior to the first dose of study drug);\n* Known hypersensitivity to ensartinib or any excipient in this product;\n* Pregnant or lactating women;\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in the study.","ALL","18 Years",{"count":19,"type":20},45,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.",[26,27,28,29],"NSCLC Stage III","Ensartinib","Chemoradiotherapy","ALK","NOT_YET_RECRUITING","2025-11-17",{"date":33,"type":34},"2025-11-19","ACTUAL",{"date":36,"type":20},"2025-12-01",{"date":38,"type":20},"2031-12-31",{"name":40,"class":41},"Shanghai Pulmonary Hospital, Shanghai, China","OTHER",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":50,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":57,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100572691","a-multicenter-real-world-clinical-study-on-the-efficacy-and-safety-of-ensartinib-as-neoadjuvant-treatment-for-anaplastic-lymphoma-kinase-alk-positive-non-small-cell-lung-cancer-nsclc-patients-100572691","NCT06736561","A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.","Inclusion Criteria:\n\n1. Cohort 1: Female or male aged \\>=18 years;\n2. Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;\n3. Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n4. Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.\n5. Cohort 2: Female or male aged \\>=18 years;\n6. Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;\n7. Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;\n8. Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n9. Cohort 2: Signed informed consent form;\n10. Cohort 3: Female or male aged \\>=18 years;\n11. Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;\n12. Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;\n13. Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;\n14. Cohort 3: Signed informed consent form.\n\nExclusion Criteria:\n\n1. Cohort 1: Patients who have received treatment with Ensartinib after the project has started;\n2. Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n3. Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n4. Cohort 1: Patients who are participating in other clinical studies outside of this research;\n5. Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.\n6. Cohort 2: Patients who have received Ensartinib treatment before the study started;\n7. Cohort 2: Patients who have received other systemic treatments besides Ensartinib;\n8. Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;\n9. Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n10. Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n11. Cohort 2: Patients who are participating in other clinical studies outside of this research;\n12. Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.\n13. Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;\n14. Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;\n15. Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;\n16. Cohort 3: Patients who are participating in other clinical studies outside of this research;\n17. Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.",{"count":49,"type":20},100,"2 Years","OBSERVATIONAL","Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.",[54,27,55,56],"ALK Positive","NSCLC","Neoadjuvant Therapy",[54,27,55,58],"Neoadjuvant therapy","2024-12-12",{"date":61,"type":34},"2024-12-16",{"date":63,"type":20},"2025-01-01",{"date":65,"type":20},"2028-06-30",{"name":67,"class":41},"Harbin Medical University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100477522","a-real-world-study-of-ensartinib-in-advanced-alk-positive-nsclc-100477522","NCT05498064","A Real World Study of Ensartinib in Advanced ALK-positive NSCLC","A Real World Study of Ensartinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed stage III b or IV NSCLC, according to the International Association for the Study of Lung Cancer staging manual in Thoracic Oncology, 8th edition.\n2. Documented ALK-positive disease according to FISH , Ventana IHC ,RT-PCR or NGS;\n3. Patients must have demonstrated progression during or after ALK-TKI treatment;\n4. Eastern cooperative oncology group performance status (ECOG PS) of 0-2, overall survival\\>3 months;\n5. Patients need radiotherapy or can receive radiotherapy, such as bone metastatic lesions, intrapulmonary lesions, adrenal lesions, etc.\n6. Initially general blood tests including complete blood count, biochemistry, electrolytes, and urine biochemistry were performed as a routine screening in order to identify any abnormalities.\n7. Male and female patients must agree to abstain or to use two highly effective forms of contraception during the treatment period and for 90 days after the last dose of study medication.\n\nExclusion Criteria:\n\n\\-",{"count":76,"type":20},490,"The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.",[79,80,27],"Carcinoma, Non-Small-Cell Lung","Anaplastic Lymphoma Kinase I1171N",[79,82,27,83],"Anaplastic Lymphoma Kinase","Real world study","RECRUITING","2022-08-10",{"date":87,"type":34},"2022-08-11",{"date":89,"type":34},"2022-05-13",{"date":91,"type":20},"2028-12-01",{"name":93,"class":41},"Peking Union Medical College Hospital",1]