[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651015":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":29,"collaborators":11,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":11,"enrollmentInfo":40,"targetDuration":11,"studyType":43,"phases":44,"briefSummary":46,"conditions":47,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":11},{"fullName":5,"class":6},"Jiangsu Hansoh Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HS-10504 group","EXPERIMENTAL",null,[13],"Drug: HS-10504",{"label":15,"type":16,"description":11,"interventionNames":17},"Platinum-Based Doublet Chemotherapy Group","ACTIVE_COMPARATOR",[18],"Drug: platinum-based doublet chemotherapy (Pemetrexed and Cisplatin\u002FCarboplatin)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","HS-10504","HS-10504 tablet",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"platinum-based doublet chemotherapy (Pemetrexed and Cisplatin\u002FCarboplatin)","Participants will receive 4 cycles of standard platinum-based doublet chemotherapy (selected by the investigator based on participant's condition and tolerance):\n\n* Option 1: Pemetrexed 500 mg\u002Fm² IV infusion + Cisplatin 75 mg\u002Fm² IV infusion on Day 1 of each 21-day cycle.\n* Option 2: Pemetrexed 500 mg\u002Fm² IV infusion + Carboplatin AUC 5 IV infusion on Day 1 of each 21-day cycle.\n* Substitution Rule: Cisplatin and carboplatin may be substituted if intolerable due to safety, while maintaining 4 total cycles of platinum-based therapy.",[15],{"type":30,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":41,"type":42},206,"ESTIMATED","INTERVENTIONAL",[45],"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.",[48],"Advanced or Metastatic NSCLC","NOT_YET_RECRUITING","2026-08-07",{"date":52,"type":53},"2026-08-10","ACTUAL",{"date":55,"type":42},"2026-09-17",{"date":57,"type":42},"2031-07-31",{"name":5,"class":6}]