[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,75,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100621745","iruplinalkib-in-alk-positive-advanced-lung-adenocarcinoma-after-lorlatinib-100621745",false,"NCT07374614","Iruplinalkib in ALK-Positive Advanced Lung Adenocarcinoma After Lorlatinib","An Observational Study of the Efficacy and Safety of Iruplinalkib(WX-0593) in ALK-positive Advanced Lung Adenocarcinoma Following Lorlatinib Treatment","SAILOR","Inclusion Criteria:\n\n1. Population: Male or female patients aged ≥18 years.\n2. Diagnosis: Histologically or cytologically confirmed advanced lung adenocarcinoma.\n3. Molecular Status: Documentation of ALK rearrangement confirmed by a validated test (e.g., NGS, IHC, FISH).\n4. Prior Therapy: Prior treatment with lorlatinib (in any line of therapy), with documented disease progression or intolerance.\n5. Current Therapy: Initiated treatment with iruplinalkib in the real-world setting.\n6. Measurability: Presence of at least one evaluable lesion (measurable or non-measurable) for response assessment.\n7. Data Availability: availability of key clinical data (baseline characteristics, treatment history, and follow-up outcomes).\n\nExclusion Criteria:\n\n1. Lack of Exposure: Patients who never actually received iruplinalkib or took only a trivial amount (e.g., \\\u003C 1 week\u002Fcycle) before withdrawal for non-medical reasons.\n2. Wrong Diagnosis: Active malignancy of other histological types (excluding treated basal cell carcinoma, etc.).\n3. Confounding: Participation in another interventional clinical trial involving an investigational anti-tumor drug concurrently.\n4. Pregnancy: Pregnant or breastfeeding women.\n5. Data Quality: Missing critical medical records that preclude assessment of primary endpoints (e.g., unknown start date, unknown prior therapy).","ALL","18 Years",{"count":20,"type":21},20,"ESTIMATED","OBSERVATIONAL","This observational study aims to evaluate the real-world effectiveness and safety of iruplinalkib in patients with advanced ALK-positive lung adenocarcinoma who have progressed on or are intolerant to prior lorlatinib therapy. The results are expected to provide real-world evidence to inform clinical decision-making for this heavily pretreated patient population.",[25,26,27,28,29,30],"Non-Small Cell Lung Cancer","ALK","Iruplinalkib","Lorlatinib","Real-world Study","Observational Study",[27,32,33,34],"ALK-postive","Post-Lorlatinib","Advanced Lung Adenocarcinoma","RECRUITING","2026-01-24",{"date":38,"type":39},"2026-01-29","ACTUAL",{"date":41,"type":21},"2026-01-31",{"date":43,"type":21},"2028-12-31",{"name":45,"class":46},"Peking University Shenzhen Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100611032","phase-2-ensartinib-after-chemoradiotherapy-in-stage-iii-alk-mutated-nsclc-100611032","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.",{"count":56,"type":21},45,"INTERVENTIONAL",[59],"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.",[62,63,64,26],"NSCLC Stage III","Ensartinib","Chemoradiotherapy","NOT_YET_RECRUITING","2025-11-17",{"date":68,"type":39},"2025-11-19",{"date":70,"type":21},"2025-12-01",{"date":72,"type":21},"2031-12-31",{"name":74,"class":46},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":84,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100575463","phase-2-the-efficacy-and-safety-of-ensartinib-as-adjuvant-therapy-in-stage-i-alk-positive-nsclc-patients-with-high-risk-factors-100575463","NCT06772610","The Efficacy and Safety of Ensartinib As Adjuvant Therapy in Stage I ALK-positive NSCLC Patients with High Risk Factors","Inclusion Criteria:\n\n* Aged 18-75 years;\n* ECOG performance status 0-1;\n* Postoperative histopathology confirms R0 resection with TNM stage I pulmonary adenocarcinoma;\n* Confirmed ALK fusion-positive by FISH, IHC, or NGS;\n* No prior systemic treatment after surgery;\n* At least one high-risk recurrence factor: poorly differentiated tumor, vascular invasion, wedge resection, visceral pleura involvement, uncertain lymph node status, intrapulmonary dissemination;\n* Able to start Ensartinib adjuvant therapy within 4-8 weeks after surgery;\n* Hematological, biochemical, and organ function requirements met: Hemoglobin ≥100 g\u002FL; Absolute neutrophil count ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Total bilirubin ≤2 times the upper limit of normal; ALT and AST ≤2.5 times the upper limit of normal; Creatinine ≤1.5 times the upper limit of normal; Creatinine clearance ≥60 mL\u002Fmin;\n* Women of childbearing potential must have a negative urine pregnancy test - within 7 days prior to starting treatment;\n* Informed consent obtained from the patient or their legal representative;\n* Men and women of childbearing potential must agree to use reliable - contraception from enrollment in the study until 8 weeks after discontinuation of the study drug.\n\nExclusion Criteria:\n\n* Previous systemic treatment for NSCLC;\n* Previous local radiotherapy for NSCLC;\n* Unable to take oral medications;\n* Known allergy to Ensartinib or any component of this product;\n* History of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring steroid treatment, or any clinically evident active interstitial lung disease; baseline CT scan showing idiopathic pulmonary fibrosis;\n* Any unstable systemic diseases, including: active infections, uncontrolled hypertension, unstable angina, angina onset within the last 3 months, congestive heart failure (≥ NYHA class II), myocardial infarction (within 6 months prior to enrollment), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases;\n* Pregnant or breastfeeding women;\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Any other conditions that the investigator deems unsuitable for enrollment.","75 Years",{"count":83,"type":21},40,[59],"This study is designed to evaluate the efficacy and safety of a 2-year adjuvant treatment with Ensartinib in stage I ALK-positive non-small cell lung cancer (NSCLC) patients with high-risk factors. The study population includes patients with ALK-positive NSCLC who have undergone R0 resection and have not received any postoperative treatment, with a TNM stage of I and high-risk factors for recurrence.",[87,26,88,89],"NSCLC","Stage I","Adjuvant Treatment",[87,91,92,93],"ALK positive","adjuvant treatment","high-risk factors","2025-01-10",{"date":96,"type":39},"2025-01-13",{"date":98,"type":21},"2025-03-15",{"date":100,"type":21},"2032-03-31",{"name":74,"class":46},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":111,"studyType":22,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100566236","the-incidence-and-risk-factors-of-central-nervous-system-adverse-events-of-lorlatinib-in-patients-with-alk-positive-advanced-non-small-cell-lung-cancer-a-real-world-study-100566236","NCT06652555","The Incidence and Risk Factors of Central Nervous System Adverse Events of Lorlatinib in Patients with ALK-positive Advanced Non-small Cell Lung Cancer: a Real-world Study","The CNS AE of Lorlatinib in Patients with ALK-positive Advanced NSCLC","Inclusion Criteria:\n\n* Patients with locally advanced (stage IIIb\u002FIIIc), metastatic, or recurrent (stage IV) NSCLC confirmed by histology or cytology, who are not eligible for curative surgery and cannot undergo definitive radiotherapy\u002Fchemotherapy, according to the 8th edition of the TNM staging classification by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer;\n* ALK-positive and the test results were based on RT-PCR \u002FFISH \u002FIHC \u002FNGS methods in the laboratory department or testing institution of the hospital\n* receiving targeted therapy with Lorlatinib\n* age ≥18 years old\n* follow-up after receipt of Lorlatinib\n* voluntarily participate in the study and sign informed consent\n\nExclusion Criteria:\n\n* evidence of any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, active infections including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).\n* combined with other malignant tumors and received other anti-tumor therapy during the treatment of Lorlatinib",{"count":110,"type":21},100,"1 Year","The goal of this study is to investigate the incidence and risk factors of central nervous system adverse events of Lorlatinib in patients with ALK-positive advanced non-small cell lung cancer.",[26,87],[26,87],"2024-10-19",{"date":117,"type":39},"2024-10-22",{"date":119,"type":21},"2024-10-30",{"date":121,"type":21},"2027-09-29",{"name":74,"class":46}]