[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-positive-non-small-cell-lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-positive-non-small-cell-lung-cancer-nsclc":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,35,65],{"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":4,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":24,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":31,"locationsCount":34},"100580190","expanded-access-program-of-neladalkib-nvl-655-for-patients-with-advanced-alk-nsclc-or-other-alk-solid-tumors-100580190",false,"NCT06834074","Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors","Expanded Access Treatment of Neladalkib (NVL-655) in Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors","NVL-655-EAP","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC or other solid tumors with a documented ALK rearrangement or activating ALK mutation.\n3. Previously received at least one ALK TKI (for patients with NSCLC) or any prior therapy (for patients with other solid tumors), with no comparable or satisfactory alternative treatment options, in the opinion of the treating physician.\n4. Enrollment in a clinical trial of neladalkib is not possible.\n5. Adequate organ function and bone marrow reserve.\n\nExclusion Criteria:\n\n1. Prior receipt of neladalkib.\n2. Previous surgery, chemotherapy, radiotherapy or other anti-cancer therapy or participation in other studies within timeframe indicated in the protocol.\n3. Ongoing anti-cancer therapy.","ALL","18 Years","EXPANDED_ACCESS","The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.",[22,23],"Non Small Cell Lung Cancer","ALK-positive Non-small Cell Lung Cancer (NSCLC)",[25],"ALK-positive Solid Tumors","AVAILABLE","2026-06-18",{"date":29,"type":30},"2026-06-23","ACTUAL",{"name":32,"class":33},"Nuvalent Inc.","INDUSTRY",46,{"id":36,"slug":37,"hasResults":11,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":4,"eligibilityCriteria":41,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":42,"targetDuration":4,"studyType":45,"phases":4,"briefSummary":46,"conditions":47,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100643034","vortioxetine-for-cognitive-function-in-alk-positive-nsclc-treated-with-lorlatinib-100643034","NCT07633626","Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib","Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ALK\u002FROS1-positive non-small cell lung cancer (NSCLC), stage IIIB\u002FIV.\n* Currently receiving lorlatinib as part of the standard therapeutic regimen.\n* Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.\n* Age \\>= 18 years.\n* ECOG performance status 0-2.\n* Ability to understand and sign informed consent.\n* Expected survival \\>= 6 months.\n* Planned initiation of vortioxetine as part of standard care.\n* Ability to complete neuropsychological tests and questionnaires in Spanish.\n\nExclusion Criteria:\n\n* Prior diagnosis of major cognitive impairment unrelated to cancer treatment.\n* Current use of another antidepressant that cannot be discontinued.\n* Uncontrolled major psychiatric disorder.\n* History of uncontrolled epilepsy or recent seizures.\n* Severe hepatic or renal impairment.\n* Known hypersensitivity to vortioxetine.\n* Participation in another clinical trial within the past 30 days.\n* Inability to provide informed consent.\n* Life expectancy \\\u003C 3 months.\n* Contraindications to vortioxetine (e.g., concomitant MAOI use).\n* Prior vortioxetine use.\n* Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.",{"count":43,"type":44},24,"ESTIMATED","OBSERVATIONAL","This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.\n\nLorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.\n\nTwenty-four adult patients with ALK\u002FROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg\u002Fday) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.",[48,49,50,23,51,52],"Advanced ALK\u002FROS1-positive NSCLC","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Adenocarcinoma","Cognitive Dysfunction","Depression","RECRUITING","2026-06-04",{"date":56,"type":30},"2026-06-08",{"date":58,"type":30},"2026-03-10",{"date":60,"type":44},"2027-11-10",{"name":62,"class":63},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":64},"100576460","phase-4-efficacy-and-safety-of-ensartinib-in-neoadjuvant-therapy-for-stage-iia---iiib-operable-or-potentially-operable-alk-positive-lung-adenocarcinoma-a-multicenter-real-world-clinical-study-100576460","NCT06785584","Efficacy and Safety of Ensartinib in Neoadjuvant Therapy for Stage IIA - IIIB (Operable or Potentially Operable) ALK-Positive Lung Adenocarcinoma ：A Multicenter, Real-World Clinical Study","Inclusion Criteria:\n\n* Age ≥18\n* Histologically or cytologically confirmed lung adenocarcinoma\n* Evaluated resectable TNM stage IIA-IIIB (operable or potentially operable) non-small cell lung cancer (NSCLC)\n* Alk-positive as determined by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods，before treatment with ALK inhibitors\n* Measurable lesions were determined with the use of the Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria) on CT scans\n* Magnetic resonance imaging (MRI) or CT scans of the brain show no metastatic disease\n* Tumors contained components of squamous cell carcinoma, large-cell neuroendocrine carcinoma, or small-cell carcinoma\n* Severe infections, including COVID-19, including but not limited to hospitalization due to complications of infection within the 4 weeks prior to starting study treatment\n* Have not received chemotherapy, radiotherapy, or biological therapy\n* Hemoglobin ≥100 g\u002FL(which can be maintained or exceeded by blood transfusion); Absolute neutrophil count ≥2.0×109\u002FL; Platelet count ≥100×109\u002FL\n* Total bilirubin ≤1.5 times upper limit of normal; ALT and AST≤2.5 times the upper limit of normal; CREA ≤1.5 times the upper limit of normal and CREA clearance ≥60mL\u002Fmin\n* Women of childbearing age (15 to 49 years) must undergo a urine pregnancy test within 7 days before starting treatment and the result is negative\n* Informed consent is obtained from patients or their legal representatives\n* Able to swallow oral medications normally\n* ECOG behavior status score is 0 to 1\n* Men and women of reproductive age agree to use a reliable method of contraception before entering the trial, during the study and up to eight weeks after discontinuation\n* Stable health status, including no acute exacerbations of chronic diseases, serious infections, or major surgeries during the first 4 weeks of enrollment, as indicated in other inclusion\u002Fexclusion criteria\n\nExclusion Criteria:\n\n* Have received any systemic anti-cancer treatment for locally advanced non-small cell lung cancer, including chemotherapy, biotherapy (including ALK-TKI), immunotherapy, or any investigational drug\n* PET-CT scan or biopsy results showing unresectable stage III and IV disease with distant metastasis (including malignant pleural effusion)\n* Patients who had a cancer other than NSCLC within 5 years before the initiation of study treatment\n* Allergy to ensartinib or any of the ingredients in this product\n* Previous history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonia requiring hormone therapy, or any clinically proven active interstitial lung disease;Baseline CT scans found idiopathic pulmonary fibrosis\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow preparations, or previous major bowel resection resulting in inadequate absorption of ensartinib\n* Any unstable systemic illness, including active infection, uncontrolled hypertension, unstable angina, angina with onset within the last 3 months, congestive heart failure (≥ New York Heart Association \\[NYHA\\] class II), myocardial infarction (within 6 months before enrollment), severe arrhythmias requiring medical therapy, or hepatic, renal, or metabolic disease\n* Human immunodeficiency virus (HIV) infection\n* Pregnant or lactating women\n* A definite past history of neurological or psychiatric disorders, including epilepsy or dementia\n* History of organ transplantation\n* Rheumatic immune-related diseases\n* Other cases that the researcher deemed unsuitable for enrollment",{"count":72,"type":44},30,"INTERVENTIONAL",[75],"PHASE4","According to the Global Cancer Statistics 2022 report, lung cancer is the most common type of cancer (12.4% of the total) and the leading cause of cancer deaths (18.7% of total cancer deaths). According to the pathological classification of patients, lung cancer is divided into small cell lung cancer and non-small cell lung cancer, of which non-small cell lung cancer (NSCLC) accounts for 80-85% of all lung cancer.\n\nSurgery is the preferred treatment for patients with early-stage lung cancer, according to the 2024 CSCO Guidelines. However, most patients have the possibility of recurrence and metastasis after surgery. The 5-year survival rate of patients with stage IA NSCLC is 80%-90%, but the 5-year survival rate of patients with stage ⅢB NSCLC drops to 40%. Neoadjuvant therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC) in order to prolong the survival of patients.\n\nIn the past few years, many driver genes of NSCLC have been identified, and anaplastic lymphoma kinase (ALK) is one of them. ALK was first identified in anaplastic large cell lymphoma (ALCL). Studies at home and abroad have shown that ALK-rearranged (positive)NSCLC accounts for about 3%-7% of all NSCLC patients.\n\nMany studies have suggested that ALK-TKI is clinically feasible as a neoadjuvant therapy for ALK positve patients with locally advanced NSCLC.\n\nThe investigators designed this study to explore the efficacy of enshatinib neoadjuvant therapy in patients with stage IIA to III ALK-positive lung adenocarcinoma",[78,23,79,80],"ALK-positive Advanced NSCLC","MPR","Neoadjuvant Therapy",[82,80,83,79],"Ensartinib","ALK-Positive Lung Adenocarcinoma","NOT_YET_RECRUITING","2025-01-19",{"date":87,"type":30},"2025-01-21",{"date":89,"type":44},"2025-02-01",{"date":91,"type":44},"2025-12-01",{"name":93,"class":63},"Fujian Medical University Union Hospital"]