[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-caner\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-caner":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636199","phase-2-a-phase-2-study-of-luvometinib-combined-with-anlotinib-in-kras-mutated-nsclc-100636199",false,"NCT07562581","A Phase 2 Study of Luvometinib Combined With Anlotinib in KRAS-mutated NSCLC","A Multicenter, Open-label, Single-arm Phase 2 Study to Evaluate the Efficacy and Safety of Luvometinib Combined With Anlotinib in Patients With KRAS-mutated Metastatic Non-small Cell Lung Cancer","Inclusion Criteria\n\n1. aged between ≥ 18 years and ≤75 years; regardless of male or female.\n2. Histologically and\u002For cytologically confirmed diagnosis of non-small cell lung caner,and the clinical stage is IV(AJCC 4th）; Received at least one line of systemic treatment(including platinum-based chemotherapy ± PD-(L)1) during the stage IV, and disease progression occured during or after the treatment.\n3. KRAS mutation positive.\n4. ECOG score 0-1. 5. Expected survival time ≥ 3 months.\n\n6．At least one intracranial measurable lesion according to RECIST v1.1 criteria.\n\n7．Adequate organ function within 7 days before enrollment. 8. Recovery to ≤grade 1 or return to baseline from previous treatment-related adverse events (according to CTCAE 5.0), except for adverse events such as hair loss that are judged by the investigators to be safe and do not violate other inclusion criteria.\n\n9\\. Avoid excessive exposure to sunlight, and be willing to use sufficient sunscreen when there is expected to be sunlight exposure.\n\n10\\. Take contraceptive measures as required.\n\nExclusion Criteria\n\n1．Patients who have previously received any of the following treatments:\n\n1. Prior treatment with MEK inhibitors、anlotinib or other VEGFR-TKI(such as cabozantinib, sorafenib, apatinib,etc);\n2. Major surgery within 28 days or minor surgery within 14 days prior to the first dose, or need to undergo major surgery during the study treatment;\n3. Systemic anti-cancer treatment (including chemotherapy, targeted therapy, immunotherapy, and other clinical trial drug treatments) within 28 days prior to the first dose or within 5 drug half-lives (whichever is shorter).\n4. Treatment with traditional Chinese medicine, Chinese patent medicine or modern Chinese medicine preparations with anti-tumor indications within 7 days prior to the first dose;\n5. Radical radiotherapy within 28 days prior to the first dose; palliative radiotherapy allowed if ≥14 days before first dose;\n6. Live or live-attenuated vaccine within 28 days prior to the first dose; other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose;\n7. History of allogeneic organ transplantation or allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months prior to the first dose.\n\n   2．Active CNS metastases; brainstem, leptomeningeal, spinal cord metastases or spinal cord compression.\n\n   3.Small cell lung cancer (including mixed SCLC\u002FNSCLC) or cavitary central squamous cell carcinoma.\n\n   4.Receipt of ≥4 prior lines of systemic anticancer therapy. 5.Active autoimmune disease requiring systemic therapy in the past 2 years,except: stable disease on replacement therapy without systemic treatment; non-systemic dermatologic conditions (vitiligo, psoriasis) or alopecia.\n\n   6.Active infection requiring systemic therapy within 2 weeks before first dose. 7.Uncontrolled hypertension. 8.Dysphagia, active gastrointestinal disease, malabsorption, or any condition impairing study drug absorption.\n\n   9.Retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED), uncontrolled glaucoma, or other ocular disease interfering with ocular toxicity assessment.\n\n   10.Current or previous idiopathic pulmonary fibrosis\u002Fpneumonitis; active ILD, pneumonitis (including clinically significant radiation pneumonitis), pulmonary fibrosis; history of tracheal fistula; continuous oxygen requirement due to severe dyspnea or respiratory insufficiency.\n\n   11.Active HBV or HCV; known AIDS or positive HIV; active tuberculosis or syphilis.\n\n   12.Tumor invasion into major vessels, heart, pericardium, trachea, esophagus, or high risk of esophagotracheal\u002Fesophagopleural fistula.\n\n   13.Significant hemoptysis within 1 month before first dose; clinically significant bleeding, bleeding tendency, coagulopathy, or history of ≥Grade 3 thrombosis.\n\n   14.Symptomatic or recurrent pleural effusion, ascites, or pericardial effusion requiring frequent drainage.\n\n   15.Other malignancy diagnosed within 5 years before first dose.","ALL","18 Years","75 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Aim to evaluate the efficacy and safety of luvometinib combined with anlotinib in patients with KRAS-mutated non-small cell lung caner",[27,28,29,30],"Non-small Cell Lung Caner","KRAS-mutated","Metastasis","Previous Treamted","NOT_YET_RECRUITING","2026-04-25",{"date":34,"type":35},"2026-05-01","ACTUAL",{"date":37,"type":21},"2026-06",{"date":39,"type":21},"2030-06",{"name":41,"class":42},"Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100601420","ai-based-deepgem-tool-for-predicting-gene-mutations-in-nsclc-patients-a-randomized-controlled-study-100601420","NCT07110259","AI-Based DeepGEM Tool for Predicting Gene Mutations in NSCLC Patients: A Randomized Controlled Study","Application of the Artificial Intelligence-Based Gene Mutation Prediction Tool DeepGEM in Patients With Non-Small Cell Lung Cancer (NSCLC): A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive, at the time of enrollment.\n* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with clinical stage II-IV as per the 8th edition of the AJCC staging system.\n* Availability of qualified histopathological whole-slide images that can be reviewed through the KindMED system(DeepGEM).\n* Successful mutation prediction of EGFR, ALK, or ROS1 by the DeepGEM AI tool.\n* No prior systemic anti-cancer therapy, including chemotherapy, targeted therapy, or immunotherapy.\n* Willing and able to comply with study requirements, including follow-up and treatment; written informed consent must be provided.\n\nExclusion Criteria:\n\n* Prior systemic anti-tumor therapy (chemotherapy, radiotherapy, targeted therapy-including but not limited to monoclonal antibodies or tyrosine kinase inhibitors) before enrollment.\n* Failure of DeepGEM analysis or unqualified histopathological image quality.\n* History of any other malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma (e.g., cervical carcinoma in situ).\n* Cognitive or psychological barriers to understanding or accepting AI-based prediction or molecular testing.\n* Pregnant or breastfeeding women, or women of childbearing potential who are not using effective contraception.\n* Any other clinical condition that, in the opinion of the investigators, may interfere with the study protocol or compromise participant safety, including poor compliance with study procedures.",{"count":52,"type":21},950,[54],"NA","This prospective, multicenter, randomized controlled trial aims to evaluate the clinical utility of DeepGEM, an artificial intelligence (AI)-based mutation prediction tool based on histopathological whole-slide images, in patients with non-small cell lung cancer (NSCLC). The study will assess whether DeepGEM can facilitate molecular testing, increase targeted therapy utilization, and improve survival outcomes in a real-world clinical setting. Patients with stage II-IV treatment-naïve NSCLC and qualified pathology slides for DeepGEM analysis will be enrolled. Eligible participants with AI-predicted EGFR, ALK, or ROS1 mutations will be randomized in a 4:1 ratio to either the DeepGEM-informed group (clinicians can access AI results to guide further testing and treatment) or the standard care group (clinicians are blinded to AI results and follow routine care).",[57],"Non Small Cell Lung Caner",[59,60],"Artificial intelligence","gene mutations","2025-07-31",{"date":63,"type":35},"2025-08-07",{"date":61,"type":21},{"date":66,"type":21},"2028-07-31",{"name":68,"class":69},"Jianxing He","OTHER"]