[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"alk-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:alk-positive":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100644656","management-strategy-of-1l-lorlatinib-with-hyperlipidemia-in-stage-iiib-iv-alk-positive-nsclc-100644656",false,"NCT07674524","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC: A Multi-center Prospective Study in China","Inclusion Criteria:• Inclusion Criteria (Part A and Part B)\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment (Part A and Part B):\n\n1. Diagnosis:\n\n   1. Histologically or cytologically confirmed locally advanced \\[defined as Stage IIIB\u002FC per AJCC v7.0 and not amenable to multimodality treatment\\] or metastatic (Stage IV) ALK-positive NSCLC; ALK status must be confirmed by Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC (Ventana ULTRA or XT platform), FISH, PCR, next-generation sequencing (NGS), or circulating tumor DNA (ctDNA) testing;\n   2. At least one measurable target lesion per RECIST v1.1, not previously irradiated; brain metastases are allowed;\n2. No prior systemic therapy for advanced (Stage IIIB\u002FC not amenable to multimodality treatment) or metastatic (Stage IV) disease;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2;\n4. Age ≥ 18 years;\n5. Hyperlipidemia during first-line lorlatinib treatment, with ULN ≤ TC \\\u003C 12.93 mmol\u002FL (Grade 1-3);\n6. Life expectancy ≥ 6 months;\n7. Negative serum pregnancy test at screening for women of childbearing potential. Non-childbearing potential must meet at least one of the following:\n\n   1. Postmenopausal status: regular menstrual cessation ≥ 12 months with no other pathological or physiological cause (serum FSH level may be used to confirm postmenopausal status, if applicable);\n   2. Hysterectomy and\u002For bilateral oophorectomy;\n   3. Medically confirmed ovarian failure; All other women (including those with tubal ligation) are considered of childbearing potential;\n8. Provide signed and dated informed consent from the patient (or legal representative), indicating full understanding of the study-related information.\n\nPart B Additional Inclusion Criteria\n\nPatients with at least one prior major ASCVD event, or baseline LDL-C ≥ 4.9 mmol\u002FL ± high-risk factors.\n\nMajor ASCVD events:\n\n1. Acute coronary syndrome (ACS) within the past 1 year;\n2. History of myocardial infarction (excluding recent ACS);\n3. History of ischemic stroke;\n4. Symptomatic peripheral artery disease (PAD), including prior revascularization or amputation.\n\nHigh-risk factors (prioritized):\n\n1. Premature coronary artery disease (male \\\u003C 55 years; female \\\u003C 65 years);\n2. Familial hypercholesterolemia;\n3. History of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);\n4. Diabetes mellitus;\n5. Hypertension;\n6. Chronic kidney disease (CKD) stage 3-4;\n7. Current smoker. -\n\nExclusion Criteria:\n\nExclusion Criteria (Part A and Part B)\n\n1. Mixed squamous cell carcinoma, large cell carcinoma, or small cell lung cancer\n2. Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug\n3. Diagnosed genetic hypercholesterolemia (e.g., familial hypercholesterolemia, Part A only) or secondary dyslipidemia with a clear etiology (e.g., hypothyroidism, uncontrolled diabetes, nephrotic syndrome)\n4. Known allergy or history of severe adverse reaction to any study drug (including lorlatinib, statins, ezetimibe, or evolocumab)\n5. Presence of other severe diseases that may affect study compliance or outcome assessment, including advanced renal failure (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or severe hepatic impairment (Child-Pugh Class C)\n6. Pregnant or lactating women, or fertile individuals (male or female) unwilling to use effective contraception during the study\n7. Currently participating in another interventional clinical study that may interfere with this study; patients expected to be unable to complete follow-up or the first tumor efficacy assessment; patients with mental or psychological disorders who cannot provide informed consent or comply with study requirements (including treatment and follow-up)\n\nPart B Additional Exclusion Criteria\n\nSubjects meeting any of the following criteria will not be included in this clinical study:\n\n1. Major surgery within 4 weeks prior to randomization; minor surgery (e.g., port placement) is permitted provided the incision is adequately healed\n2. Radiotherapy within 2 weeks prior to enrollment, including stereotactic or partial brain radiotherapy. Patients who complete whole brain radiotherapy within 4 weeks prior to randomization, or palliative radiotherapy outside the CNS within 48 hours prior to randomization, are also excluded\n3. Gastrointestinal abnormalities including: inability to take oral medication; need for parenteral nutrition; prior surgery affecting absorption (e.g., total gastrectomy, gastric banding); active inflammatory bowel disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer within the past 6 months; malabsorption syndrome\n4. Known or suspected severe hypersensitivity to the study drug or any of its excipients\n5. History of extensive, disseminated, or bilateral disease, or current Grade 3-4 interstitial fibrosis\u002Finterstitial lung disease, including but not limited to: pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, and pulmonary fibrosis\n6. Active malignancy within 3 years prior to randomization (excluding NSCLC, non-melanoma skin cancer, localized prostate cancer not requiring immediate treatment, or any carcinoma in situ)\n7. Concurrent use within 12 days prior to first lorlatinib dose of:\n\n   1. Strong CYP3A inhibitors (e.g., grapefruit juice or grapefruit\u002Frelated citrus fruits \\[Seville oranges, pomelos\\]; boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole; ritonavir alone or with danoprevir, elvitegravir, indinavir, lopinavir, paritaprevir, ombitasvir, dasabuvir, saquinavir, tipranavir; telaprevir, troleandomycin, voriconazole. Topical use such as 2% ketoconazole cream is permitted where applicable)\n   2. Known narrow therapeutic index CYP3A substrates (e.g., astemizole, terfenadine, cisapride, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl \\[including transdermal patch\\], or ergot alkaloids \\[ergotamine, dihydroergotamine\\]) (withdrawn from U.S. market)\n   3. Known strong CYP3A inducers (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort)\n   4. Known narrow therapeutic index P-gp substrates (e.g., digoxin)\n8. Other severe acute or chronic medical or psychiatric conditions, including suicidal ideation or behavior within the past 1 year, that may increase the risk of study participation or study drug use, or laboratory abnormalities that may interfere with interpretation of study results, and patients deemed by the investigator to be unsuitable for enrollment\n9. Participation in another investigational drug study within 2 weeks prior to enrollment and\u002For during the study period","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","24 Years","OBSERVATIONAL","For Patients and Families\n\nBrief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC\n\nWhat is this study about?\n\nThis study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking lorlatinib (Lorbrena®) as their first treatment and have developed high cholesterol (hyperlipidemia) as a side effect.\n\nWhy is this study needed?\n\nLorlatinib is a highly effective targeted therapy, but it frequently causes elevated cholesterol and triglycerides. There is currently no standard guideline on how to best manage this side effect. This study aims to find the best approach to control lipid levels while on lorlatinib treatment.\n\nWhat will happen in this study?\n\nThe study has two parts:\n\n* Part A (Observational) : About 100 participants. Doctors manage hyperlipidemia according to routine clinical practice. Researchers simply observe and record which lipid-lowering treatments are used and how well they work.\n* Part B (Randomized Controlled Trial) : 60 participants with high-risk factors are randomly assigned to either:\n* Intensive treatment: rosuvastatin + ezetimibe + evolocumab\n* Standard treatment: rosuvastatin + ezetimibe\n\nWhat tests are involved?\n\n* Blood tests for lipid levels at baseline, Weeks 4, 8, 20, and 24\n* Routine CT or MRI scans for tumor assessment\n* Some participants in Part B may have a non-invasive vascular ultrasound (FMD) test\n* Total participation per patient: up to 7 months\n\nIs this study safe?\n\n* ✅ Approved by the Ethics Committee of Sun Yat-sen University Cancer Center\n* ✅ All drugs used (lorlatinib, statins, ezetimibe, evolocumab) are already approved and widely used\n* ✅ An independent Data Monitoring Committee (DMC) monitors safety throughout the study\n* ✅ Participants may withdraw at any time without affecting their regular care\n\nFor Healthcare Providers\n\nStudy Title: Management strategy of 1L Lorlatinib with Hyperlipidemia in Stage IIIB-IV ALK positive NSCLC: A multi-center prospective study in China\n\nSponsor \u002F Investigators: Sun Yat-sen University Cancer Center (PI: Prof. Zhang Li)\n\nStudy Type:\n\n* Part A: Observational, prospective, real-world cohort study\n* Part B: Prospective, randomized controlled trial (RCT)\n\nEstimated Enrollment: 160 participants (Part A: \\~100, Part B: 60)\n\nStudy Duration: Approximately 4 years (anticipated completion: December 2029)\n\nKey Inclusion Criteria:\n\n* Stage IIIB-IV ALK+ NSCLC (confirmed by IHC, FISH, PCR, NGS, or ctDNA)\n* No prior systemic therapy for advanced\u002Fmetastatic disease\n* ECOG PS 0-2\n* Age ≥ 18 years\n* Hyperlipidemia (ULN ≤ TC \\\u003C 12.93 mmol\u002FL, Grade 1-3) while on first-line lorlatinib\n* At least one measurable lesion per RECIST v1.1\n* Life expectancy ≥ 6 months\n\nPrimary Endpoints:\n\n* Part A: Describe real-world treatment patterns for hyperlipidemia management\n* Part B: Percentage change in LDL-C from baseline to Week 12\n\nOversight:\n\n* Independent Data Monitoring Committee (DMC)\n* Trial Management Committee\n* Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-159-01)\n\nParticipating Centers: 8 sites across China",[25,26,27,28],"Non-Small Cell Lung Cancer (NSCLC)","Hyperlipidemia","ALK Gene Mutation","ALK-positive",[30,31,26,32,33,34,35,36,37,38,39,40,41,42],"Lorlatinib","ALK-positive NSCLC","Lipid management","Statin","Ezetimibe","Evolocumab","PCSK9 inhibitor","Real-world study","Randomized controlled trial","Prospective study","Endothelial function","FMD","Multi-center","NOT_YET_RECRUITING","2026-06-24",{"date":46,"type":47},"2026-06-29","ACTUAL",{"date":49,"type":20},"2026-08-01",{"date":51,"type":20},"2029-12-31",{"name":53,"class":54},"Sun Yat-sen University","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":64,"studyType":22,"phases":4,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"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":63,"type":20},100,"2 Years","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.",[67,68,69,70],"ALK Positive","Ensartinib","NSCLC","Neoadjuvant Therapy",[67,68,69,72],"Neoadjuvant therapy","2024-12-12",{"date":75,"type":47},"2024-12-16",{"date":77,"type":20},"2025-01-01",{"date":79,"type":20},"2028-06-30",{"name":81,"class":54},"Harbin Medical University"]