[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"egfr-tki-resistant-mutation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:egfr-tki-resistant-mutation":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,75,104],{"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":26,"conditions":27,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100521547","phase-1-nintedanib-plus-egfr-tki-in-egfr-mutated-non-small-cell-lung-cancer-patients-100521547",false,"NCT06071013","Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients","A Phase I\u002FPhase II Study of Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients","Inclusion Criteria:\n\n1. Participants between 20 to 70 years old, are pathologically confirmed advanced (stage III and IV) non-small cell lung cancer.\n2. Positive EGFR mutations are diagenesis.\n3. Participants with histologically\u002Fcytologically confirmed locally advanced or metastatic adenocarcinoma subtype NSCLC after the failure of first-line EGFR tyrosine kinase inhibitors- gefitinib, erlotinib, afatinib, or osimertinib.\n4. Participants must have adequate hepatic, renal, and bone marrow function\n\nExclusion Criteria:\n\n1. Participants previously received first-line EGFR tyrosine kinase inhibitor with serious side effects.\n2. Participants have known hypertension, and chronic liver and gastrointestinal disease.\n3. Participants have known brain metastasis.\n4. Female participants who are pregnant or breast-feeding\n5. Participants have a known diagnosis of negative nPKCδ expression by immunohistochemistry (IHC).","ALL","20 Years","70 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to evaluate the efficacy and safety of Nintedanib with EGFR-TKI in participants with advanced EGFR-TKI-resistant non-small cell lung cancer",[28,29,30],"Non-small Cell Lung Cancer","EGFR Gene Mutation","EGFR-TKI Resistant Mutation",[32,33,34],"nPKC delta","Angiogenesis","EGFR TKI drug resistant","RECRUITING","2025-01-20",{"date":38,"type":39},"2025-01-23","ACTUAL",{"date":41,"type":39},"2024-02-23",{"date":43,"type":21},"2026-08-27",{"name":45,"class":46},"China Medical University Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":47},"100485242","exploring-the-mechanism-of-primary-resistance-to-third-generation-egfr-tkis-as-first-line-treatment-in-egfr-positive-advanced-nsclc-precise-study-100485242","NCT05598528","Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","PRECISE","Inclusion Criteria:\n\n1. Age \\>18 years;\n2. Histological or cytopathological diagnosed NSCLC;\n3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;\n4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;\n5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);\n6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;\n7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;\n8. Agree to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;\n2. Pregnant and lactating women;\n3. Other malignant neoplastic diseases within 3 years;\n4. Patients who have undergone other clinical drug trials;\n5. Received systemic anti-tumor therapy within 2 years;","18 Years",{"count":58,"type":21},210,"5 Years","OBSERVATIONAL","Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.\n\nHowever, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.\n\nThis study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.",[63,29,30,64,65],"Lung Cancer, Non-small Cell","Primary Resistance","Circulating Tumor DNA","2024-11-27",{"date":68,"type":39},"2024-12-02",{"date":70,"type":39},"2021-09-28",{"date":72,"type":21},"2026-12-31",{"name":74,"class":46},"Second Xiangya Hospital of Central South University",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":102,"locationsCount":47},"100544042","phase-2-osimertinib-plus-dalpiciclib-in-patients-with-egfr-mutant-cdk46-pathway-aberrant-advanced-non-small-cell-lung-cancer-following-acquired-resistance-to-third-generation-egfr-tki-a-phase-ii-trial-100544042","NCT06363734","Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4\u002F6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial","Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4\u002F6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance on Third-generation EGFR TKI： a Single-arm Phase II Trial","Inclusion Criteria:\n\n* ECOG performance status 0 to 2 with a minimum life expectancy of 12 weeks\n* Advanced non-small cell lung cancer with EGFR-sensitive mutation\n* Confirmed medical history of acquired resistance to third-generation EGFR TKI\n* Concurrent CDK4\u002F6 pathway gene dysfunctional aberrations\n* Evaluable or measurable disease as defined by RECIST, Version 1.1\n* At least one prior line of systemic chemotherapy\n* Adequate organ function\n\nExclusion Criteria:\n\n* Prior treatment with any CDK4\u002F6 inhibitor\n* Active uncontrolled\u002Funstable CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n* Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy.\n* active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade ≥2, malabsorption syndrome or previous significant bowel resection).\n* Unstable angina pectoris, Congestive heart failure, Acute myocardial infarction, Stroke or transient ischemic attack or other uncontrolled cardiovascular disease currently or within the last 6 months, Mean resting correct QT interval (QTcF) \\>470 msec for women and \\>450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value.\n* Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side effects of such therapy.\n* Major surgical procedures ≤28 days of beginning study drug or minor surgical procedures ≤7 days\n* Evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension\n* Active hepatitis B or C or known serious active infection e.g. tuberculosis or human immunodeficiency virus. Viral testing is not required for assessment of eligibility for the study.\n* Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive human immunodeficiency virus 1\u002F2 antibodies).\n* Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years.\n* Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.\n* Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n* History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs,\n* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days prior to the first dose of study treatment with the exception of monotherapy osimertinib which may continue uninterrupted during screening.\n* Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers or inhibitors of CYP3A4 within 3 weeks of the first dose of study treatment\n* Participation in another clinical study with a cytotoxic, investigational product (IP), or other anticancer drug for the treatment of advanced NSCLC if received IP from that study within 14 days of the first dose of study treatment.\n* Known hypersensitivity to the active or inactive excipients of osimertinib or dalpiciclib or drugs with a similar chemical structure or class.","75 Years",{"count":84,"type":21},32,[25],"This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4\u002F6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.",[28,88,89,30],"EGFR Activating Mutation","Cell Cycle Deregulation",[91,92,93,94,95],"NSCLC","EGFR activating mutations","Third-generation EGFR-TKI","Cell cycle signaling pathway aberrations","CDK4\u002F6 inhibitors","2024-04-14",{"date":98,"type":39},"2024-04-16",{"date":100,"type":39},"2024-04-09",{"date":72,"type":21},{"name":103,"class":46},"Tianjin Medical University Cancer Institute and Hospital",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":47},"100208734","a-retrospective-study-of-egfr-tkisgefitinib-erlotinib-and-osimertinib-in-nsclc-patients-treatment-100208734","NCT01994057","A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment","Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.","Inclusion Criteria:\n\nThe main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:\n\nuncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.","85 Years",{"count":113,"type":21},1000,"For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.",[116,30,117,118,119],"Non-small Cell Lung Cancer (NSCLC)","EGFR-TKI Sensitizing Mutation","Germline Mutations","Somatic Mutation",[121,122,123,124,125],"Non-small cell lung cancer (NSCLC);","EGFR-TKI;","Pharmacogenetics;","Precision medicine","somatic mutations ,germline mutations;","2023-04-10",{"date":128,"type":39},"2023-04-12",{"date":130,"type":4},"2012-09",{"date":132,"type":21},"2026-12",{"name":134,"class":46},"Sun Yat-sen University"]