[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Avistone Biotechnology Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":211},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,67,97,120,148,168,190],{"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":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100634370","phase-1-a-study-to-investigate-ans02-in-participants-with-egfr-mutation-positive-non-small-cell-lung-cancer-100634370",false,"NCT07538804","A Study to Investigate ANS02 in Participants With EGFR Mutation-Positive Non-Small Cell Lung Cancer","A Phase I\u002FII, Open-Label, Multicenter Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics, and Preliminary Efficacy of ANS02 in Participants With EGFR Mutation-Positive Locally Advanced or Metastatic Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With documentation of EGFR alteration\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases","ALL","18 Years",{"count":19,"type":20},294,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human (FIH) Phase I\u002FII, multi-center, open-label, study of ANS02, in patients with advanced NSCLC. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS02 as monotherapy.",[27],"Non-Small Cell Lung Cancer","RECRUITING","2026-05-20",{"date":31,"type":32},"2026-05-22","ACTUAL",{"date":34,"type":20},"2026-06-09",{"date":36,"type":20},"2029-10-30",{"name":38,"class":39},"Avistone Biotechnology Co., Ltd.","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100539742","phase-1-a-study-to-investigate-ans014004-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100539742","NCT06307795","A Study to Investigate ANS014004 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS014004 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With a pathogenetic MET alteration or ROS1 alteration or NTRK alternation\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases",{"count":49,"type":20},63,[23],"This is a Phase 1, first-in-human, open-label, multi-center study with the aim of exploring the safety, tolerability, PK, and preliminary anti-tumor activity of ANS014004 as a single agent in participants with locally advanced or metastatic solid tumors.",[53],"Locally Advanced or Metastatic Solid Tumors",[55,56,57],"ROS1","NTRK","ROS1\u002FNTRK","2026-04-15",{"date":60,"type":32},"2026-04-17",{"date":62,"type":32},"2024-06-24",{"date":64,"type":20},"2027-10",{"name":38,"class":39},15,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},"100618831","phase-2-andamertinib-with-or-without-platinum-doublet-chemotherapy-versus-platinum-doublet-chemotherapy-in-patients-with-nsclc-harboring-atypical-egfr-mutations-100618831","NCT07336732","Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations","An Open-label, Randomized, Multicenter Phase II\u002FIII Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy","KANNON-5","Inclusion Criteria:\n\n1. Age ≥18 years at the time of ICF signing.\n2. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).\n3. Confirmed EGFR atypical mutation.\n4. No prior systemic therapy for locally advanced or metastatic NSCLC.\n5. At least one measurable lesion as defined by RECIST v1.1.\n6. ECOG PS ≤1.\n7. Life expectancy≥12 weeks.\n8. Adequate organ function confirmed within 7 days prior to the first dose of study treatment\n9. Female participants must use adequate contraceptive measures during study participation and for 90 days after the last dose of study treatment and must not be breastfeeding; female subjects not of childbearing potential must meet at least one of the following criteria at screening: Postmenopausal status; Documentation of irreversible surgical sterilization.\n10. Non-sterilized males: Abstinence or contraception use; No sperm donation.\n11. Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.\n\nExclusion Criteria:\n\n1. Presence of specific genetic alterations for which approved targeted therapies are available.\n2. Recent participation (within 28 days) in another interventional clinical trial.\n3. Major surgery within 28 days prior to study entry or planned during the study period.\n4. Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.\n5. Need for specific concomitant medications (e.g., metformin) that cannot be paused during the study.\n6. History of another active malignancy within the past 5 years (except for specific cured cancers).\n7. Toxicities from prior therapy have not recovered to acceptable levels.\n8. Presence of symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression.\n9. Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites).\n10. Severe cardiovascular\u002Fcerebrovascular disease or risk factors (e.g., heart failure, history of myocardial infarction, QT prolongation, uncontrolled hypertension, etc.).\n11. History or presence of interstitial lung disease, or drug\u002Fradiation-related pneumonitis.\n12. Active autoimmune or inflammatory diseases.\n13. Active, uncontrolled infection (including HBV, HCV, HIV, syphilis, tuberculosis, etc.).\n14. Gastrointestinal disorders or surgery affecting drug ingestion or absorption.\n15. Active keratitis or ulcerative keratitis.\n16. History of hypersensitivity to the study drug, its analogs, or chemotherapy drugs (pemetrexed\u002Fplatinum agents).\n17. Recent administration (within 30 days) of a live attenuated vaccine.\n18. Psychiatric disorders or substance abuse potentially affecting compliance.\n19. Any other condition deemed by the investigator as unsuitable for study participation.",{"count":76,"type":20},40,[24],"This study is an open-label, randomized, multicenter phase II\u002FIII clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)",[80],"Non-Small-Cell Lung Cancer",[82,83,84,85,86,87],"Non-Small-Cell Lung Cance","EGFR","PACC","L861Q","Lung Cancer","EGFR ex20ins","2026-03-18",{"date":90,"type":32},"2026-03-20",{"date":92,"type":32},"2026-03-11",{"date":94,"type":20},"2029-01",{"name":38,"class":39},1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100571122","phase-1-a-study-to-investigate-ans03-in-participants-with-locally-advanced-or-metastatic-solid-tumors-100571122","NCT06716138","A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors","A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ANS03 as a Single Agent in Participants With Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2\n* Life expectancy ≥ 12 weeks\n* Measurable disease per RECIST v1.1\n* Adequate organ and marrow function as defined in the protocol\n* With documentation of ROS1 or NTRK alteration\n\nExclusion Criteria:\n\n* Active infection including tuberculosis and HBV, HCV or HIV\n* Known active or untreated CNS metastases\n* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression\n* Participants with serious cardiovascular or cerebrovascular diseases",{"count":105,"type":20},96,[23],"This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.",[109],"Locally Advanced or Metastatic Solid Tumors Harboring a ROS1 or NTRK Alteration",[57,111,55,56],"ANS03",{"date":113,"type":32},"2026-03-13",{"date":115,"type":32},"2025-03-06",{"date":117,"type":20},"2029-03-30",{"name":38,"class":39},5,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":139,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100590696","phase-3-vebreltinib-plus-plb1004-versus-platinum-based-doublet-chemotherapy-in-patients-with-egfrm-met-locally-advanced-or-metastatic-nsclc-following-egfr-tki-failure-100590696","NCT06970782","Vebreltinib Plus PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFRm, MET+, Locally Advanced or Metastatic NSCLC Following EGFR-TKI Failure","A Randomized, Controlled, Open Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and\u002For Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure","KYLIN-3","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Aged at least 18 years old.\n3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV).\n4. At least one measurable lesion as defined by RECIST V1.1.\n5. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n1. There are mutations of ALK or ROS1.\n2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.\n3. Before randomization, patients did not recover from any toxicity and\u002F or complications of previous chemotherapy, surgery, radiotherapy and other anti-cancer treatments, that is, did not fall to grade 1 or lower (National Cancer Research Common Toxicity Criteria for Adverse Events \\[NCI-CTCAE\\] v5.0), except for hair loss and irrecoverable permanent radiation damage.\n4. Major surgery or had significant traumatic injury within 4 weeks prior to the first dose of the investigational product.\n5. Pregnant or nursing women.",{"count":129,"type":20},278,[131],"PHASE3","Efficacy and Safety of Vebreltinib in Combination With PLB1004 Versus Platinum-based Doublet Chemotherapy in Patients With EGFR Mutations, MET Amplification and\u002For Overexpression, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Following EGFR-TKI Treatment Failure",[80],[135,86,136,137,138,83],"NSCLC","MET Amplification","EGFR L858R","EGFR Exon 19 Deletion","NOT_YET_RECRUITING","2025-05-20",{"date":142,"type":32},"2025-05-21",{"date":144,"type":20},"2025-05-15",{"date":146,"type":20},"2028-12-31",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":96},"100560223","phase-2-vebreltinib-plus-plb1004-as-the-first-line-therapy-for-patients-with-egfrmmet-locally-advanced-or-metastatic-nsclc-100560223","NCT06574347","Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic NSCLC.","A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.","KYLIN-2","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Aged at least 18 years old.\n3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV).\n4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .\n5. At least one measurable lesion as defined by RECIST V1.1.\n6. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n1. There are mutations of ALK or ROS1.\n2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.\n3. Pregnant or nursing women.",{"count":157,"type":20},120,[24],"Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+\u002FMET+ Locally Advanced or Metastatic NSCLC.",[80],[135,86,136,137,138,83],{"date":142,"type":32},{"date":164,"type":32},"2024-08-07",{"date":166,"type":20},"2027-07-31",{"name":38,"class":39},{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":181,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":184,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":96},"100542453","phase-1-vebreltinib-plus-plb1004-in-egfr-mutated-advanced-nsclc-with-met-amplification-or-met-overexpression-following-egfr-tki-100542453","NCT06343064","Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","A Phase Ib\u002FII Study of Vebreltinib Plus PLB1004 in EGFR-mutated, Advanced NSCLC With MET Amplification or MET Overexpression Following EGFR-TKI","KYLIN-1","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document.\n2. Aged at least 18 years old.\n3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\\~IV).\n4. EGFR mutations, including exon 19 deletion and exon 21 L858R.\n5. C-Met overexpression and\u002For c-Met amplification confirmed after treatment with EGFR-TKI.\n6. At least one measurable lesion as defined by RECIST V1.1.\n7. ECOG performance status 0 to 1.\n\nExclusion Criteria:\n\n1. Previous treatment with MET inhibitors or HGF-targeted therapy.\n2. There are mutations of ALK or ROS1.\n3. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.\n4. Pregnant or nursing women.",{"count":177,"type":20},156,[23,24],"Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 in EGFR TKI Relapsed MET Amplified or MET Expression in NSCLC",[80],[80,83,135,86,182,183],"MET Amplified","MET Expression",{"date":142,"type":32},{"date":186,"type":32},"2023-06-13",{"date":188,"type":20},"2026-12-31",{"name":38,"class":39},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100519664","phase-1-a-study-of-the-oral-egfr-inhibitor-plb1004-in-non-small-cell-lung-cancer-100519664","NCT06046495","A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer","A Phase I Open-label, Multi-dose, Dose Escalation and Dose Expansion Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Ability to understand and willingness to sign a written informed consent document;\n2. Male or female adult patients 18 years of age or older;\n3. Patients should have recovered from toxicities related to prior anti-tumor therapy;\n4. Patients should have recovered from the effects of major surgery;\n5. Have a documented EGFR mutation by a local test in tissue or plasma;\n6. At least 12 weeks life expectancy;\n7. Must have at least one measurable lesion per RECIST v 1.1;\n8. Sexually active males and females of childbearing potential must agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Received radiotherapy within 14 days before enrollment;\n2. Have significant or uncontrolled systemic disease;\n3. Have significant or uncontrolled cardiovascular disease;\n4. Have had other diagnosed malignant diseases that required treatment within the past 3 years besides NSCLC;\n5. Currently have or had a history of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonia that requires steroid therapy;\n6. Have known hypersensitivity to the similar drugs and excipients of PLB1004;\n7. Pregnant or lactating women;\n8. Have used other experimental drugs within 2 weeks prior to the first dose of PLB1004;\n9. Have any condition or illness that could affect the compliance with the protocol.",{"count":198,"type":20},81,[23],"This is a Phase I, multicenter, open-label, dose escalation and dose expansion study to assess the safety and pharmacokinetic profile of PLB1004, a mono-anilino-pyrimidine compound, given alone in NSCLC patients with EGFR exon 20 insertion mutations，uncommon mutations, classical mutations (Ex19del and L858R), and drug-resistant mutation (T790M). Patients will be enrolled and dosed according to the most current protocol. This study is made of two Parts. Part 1 includes a dose escalation into 7 cohorts and patient allocation to these cohorts will be via slot allocation. Each cohort has a minimum of 3 and a maximum of 6 patients for a total of 21 - 42 patients. The patient population of the dose escalation phase will include patients with advanced NSCLC harboring EGFR classical mutations or Ex20ins mutations, or uncommon mutations. Part 2 includes an expansion phase and the expansion phase will explore one or more dose levels of PLB1004 in NSCLC patients with EGFR Ex20ins mutations, classical mutations, or uncommon mutations.",[27],"2025-04-21",{"date":204,"type":32},"2025-04-23",{"date":206,"type":32},"2024-07-08",{"date":208,"type":20},"2028-02-09",{"name":38,"class":39},7,""]