[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wayshine Biopharm, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":99},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,76],{"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":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100608818","phase-1-a-study-to-evaluate-safety-and-efficacy-of-wsd0922-fu-combo-with-osimertinib-for-nsclc-100608818",false,"NCT07206498","A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC","A Phase I\u002FII Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer","WAYWIN103","Inclusion Criteria:\n\n* ≥Age 18, gender is not limited;\n* Locally advanced or metastatic NSCLC confirmed by pathology;\n* Patients who have been genetically tested to carry EGFR sensitive mutations;\n* Blood\u002FTissue samples must be provided for testing;\n* Must have a minimum life expectancy of \\>= 3 months;\n* At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.\n* Physical Status (ECOG PS) score was 0-1;\n* Have full organ function;\n* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;\n* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.\n* Have previously received more than two EGFR-TKI inhibitors for part A;\n* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.\n* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.\n* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).\n* Skin\u002Fpressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.\n* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;\n* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;\n* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);\n* Human immunodeficiency virus (HIV) (HIV1\u002F2 antibody) positive, syphilis spirochete antibody positive .\n* Patients with interstitial lung disease.\n* History of severe cardiovascular diseases.\n* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher; Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).\n* Known alcohol or drug dependence.\n* Mental disorders or poor compliance;\n* Pregnant or lactating women;\n* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase I\u002FII, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation",[28],"Non Small Cell Lung Cancer (NSCLC)",[30,31,32,33,34,35,36,37,38],"WSD0922","WSD0922-FU","NSCLC","CNS metastasis","Brain metastasis","EGFR","C797S","Del19","L858R","RECRUITING","2025-11-21",{"date":42,"type":43},"2025-11-28","ACTUAL",{"date":45,"type":43},"2025-10-17",{"date":47,"type":21},"2029-10-14",{"name":49,"class":50},"Wayshine Biopharm, Inc.","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100582836","phase-2-a-study-to-assess-the-efficacy-of-wsd0922-fu-in-patients-with-c797s-advanced-non-small-cell-lung-cancer-100582836","NCT06868485","A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer","A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation","Inclusion criteria:\n\n* Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.\n* Male or female aged ≥18 years old.\n* Histological or cytological confirmation diagnosis of NSCLC.\n* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.\n* Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.\n* Documented EGFR mutation .\n* Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.\n* At least one lesion, not previously irradiated and not chosen for biopsy during the study.\n* Females should have evidence of non-childbearing potential.\n\nExclusion criteria:\n\n* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.\n* Symptomatic brain complications that require urgent neurosurgical or medical intervention.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.\n* Past medical history of ILD.\n* Inadequate bone marrow reserve or organ function as demonstrated.\n* Males and females of reproductive potential.\n* Known intracranial hemorrhage which is unrelated to tumor.\n* Seizures requiring a change in anti-epileptic medications.",{"count":60,"type":21},40,[25],"This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.",[64],"Non Small Cell Lung Cancer",[36,66,31,32,35],"BM","2025-08-30",{"date":69,"type":43},"2025-09-08",{"date":71,"type":43},"2025-08-18",{"date":73,"type":21},"2027-12-31",{"name":49,"class":50},18,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":98},"100564654","phase-1-a-study-to-assess-the-efficacy-and-safety-of-wsd0922-fu-in-patients-with-egfrm-advanced-non-small-cell-lung-cancer-100564654","NCT06631989","A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer","A Phase I\u002FII Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Age 18-75 years old (including the threshold value), gender is not limited;\n* Locally advanced or metastatic NSCLC confirmed by pathology;\n* Patients who have been genetically tested to carry EGFR sensitive mutations;\n* Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;\n* Must have a minimum life expectancy of \\>= 3 months;\n* At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.\n* Physical Status (ECOG PS) score was 0-1;\n* Have full organ function;\n* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;\n* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.\n* Have previously received more than one EGFR-TKI inhibitor;\n* Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.\n* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.\n* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.\n* Known active brain metastasis or progression evidence.\n* Other primary malignant tumors within 2 years before the first administration of the study drug.\n* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).\n* Skin\u002Fpressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.\n* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;\n* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;\n* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);\n* Human immunodeficiency virus (HIV) (HIV1\u002F2 antibody) positive, syphilis spirochete antibody positive .\n* Patients with interstitial lung disease.\n* History of severe cardiovascular diseases.\n* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;\n* Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).\n* Known alcohol or drug dependence.\n* Mental disorders or poor compliance;\n* Pregnant or lactating women;\n* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.","75 Years",{"count":85,"type":21},100,[24,25],"This study is a multicenter, open label, single-arm phase I\u002FII clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .",[89],"EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer",[32,35,36,66],"2025-08-22",{"date":93,"type":43},"2025-08-29",{"date":95,"type":43},"2024-09-04",{"date":73,"type":21},{"name":49,"class":50},12,""]