[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-or-metastatic-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-or-metastatic-nsclc":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"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":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100651015","phase-iii-study-of-hs-10504-versus-platinum-based-doublet-chemotherapy-in-patients-with-c797s-nsclc-100651015",false,"NCT07754123","Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC","A Randomized, Controlled, Open-Label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring EGFR C797S Mutation After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB, IIIC, or IV).\n3. Documented failure after ≥1 prior line of EGFR TKI therapy with concurrent C797S mutation.\n4. At least one measurable target lesion per RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Presence of other well-documented driver gene mutations (e.g., ALK fusion, ROS1 fusion, KRAS activating mutations, MET exon 14 skipping, HER2 mutations, RET fusion).\n2. Histological or phenotypic transformation (e.g., NSCLC to SCLC transformation, epithelial-to-mesenchymal transition) confirmed by tumor tissue obtained within 6 months prior to first dose.\n3. ≥ Grade 2 toxicities (per CTCAE v6.0) attributed to prior anti-tumor therapy (excluding alopecia and stable neurotoxicity).\n4. History of other primary malignancies.\n5. Inadequate bone marrow reserve or hepatic\u002Frenal organ function.\n6. Clinically significant cardiac abnormalities or severe\u002Funcontrolled\u002Factive cardiovascular disease.\n7. Poorly controlled diabetes mellitus or hypertension.\n8. Significant clinical bleeding tendency or history of severe arterial\u002Fvenous thromboembolic events.\n9. Severe or uncontrolled active infection.\n10. Continuous systemic corticosteroid therapy (\\>30 days) within 30 days prior to first dose, or requirement for long-term (≥30 days) corticosteroid use.\n11. Active infectious diseases (e.g., active hepatitis B virus \\[HBV\\] infection).\n12. Clinically significant gastrointestinal disorders.\n13. Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis ≥ Child-Pugh class B.\n14. Other pulmonary diseases that may interfere with assessment or management of drug-related pneumotoxicity.\n15. History of severe neurological or psychiatric disorders.","ALL","18 Years",{"count":19,"type":20},206,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC harboring EGFR C797S mutation after failure of EGFR TKI therapy.",[26],"Advanced or Metastatic NSCLC","NOT_YET_RECRUITING","2026-08-07",{"date":30,"type":31},"2026-08-10","ACTUAL",{"date":33,"type":20},"2026-09-17",{"date":35,"type":20},"2031-07-31",{"name":37,"class":38},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":48,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100472697","phase-1-phase-12-study-of-hs-10375-in-patients-with-advanced-or-metastatic-non-small-cell-lung-cancernsclc-100472697","NCT05435248","Phase 1\u002F2 Study of HS-10375 in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","A Phase 1\u002F2, Open-label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10375 Monotherapy in Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)","Inclusion Criteria:\n\n1. Men or women greater than or equal to 18 years.\n2. Locally advanced or metastatic NSCLC patients confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable .\n3. Pathological, NSCLC tissue samples can be used to test EGFR C797S mutation by central laboratory for Phase 1b and Phase II subjects.\n4. At least one measurable lesion in accordance with RECIST 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\\~1.\n6. Estimated life expectancy \\>12 weeks.\n7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n8. Females must have the evidence of non-childbearing potential.\n9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n   * Previous or current treatment with EGFR C797S inhibitors.\n   * Any cytotoxic chemotherapy, anticancer Chinese medicine and targeted small molecule inhibitors within 14 days of the first dose of HS-10375.\n   * Any investigational agents and large molecule antibodies within 28 days of the first dose of HS-10375.\n   * Local radiotherapy for palliation within 2 weeks of the first dose of HS-10375, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose of HS-10375.\n   * Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of HS-10375.\n2. Inadequate bone marrow reserve or serious organ dysfunction.\n3. Uncontrolled pleural, ascites or pericardial effusion.\n4. Known and untreated, or active central nervous system metastases.\n5. Active autoimmune diseases or active infectious disease.\n6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.\n7. History of hypersensitivity to any active or inactive ingredient of HS-10375 or to drugs with a similar chemical structure or drugs belonging to the same category of HS-10375.\n8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.\n9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.\n10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.\n11. History of neuropathy or mental disorders, including epilepsy and dementia.",{"count":47,"type":20},354,[49,50],"PHASE1","PHASE2","HS-10375 is an oral, highly selective, small molecular inhibitor of EGFR C797S. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10375 in Chinese advanced or metastatic NSCLC.",[26],[54,55,56],"Advanced or metastatic NSCLC","EGFR C797S mutation","HS-10375","RECRUITING","2024-11-01",{"date":60,"type":31},"2024-11-04",{"date":62,"type":31},"2022-03-02",{"date":64,"type":20},"2026-03-31",{"name":37,"class":38},1]