[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604811":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":32,"locations":11,"responsibleParty":43,"collaborators":11,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":11,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":11,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":11},{"fullName":5,"class":6},"Guangzhou JOYO Pharma Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JYP0322 tablets","EXPERIMENTAL",null,[13],"Drug: JYP0322 tablets",{"label":15,"type":10,"description":11,"interventionNames":16},"Pemetrexed Disodium",[17,18],"Drug: Pemetrexed injection","Drug: Cross-over to JYP0322",[20,25,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","Pemetrexed injection","Randomization to either JYP0322 or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (JYP0322: platinum-based doublet-chemotherapy) ratio",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Cross-over to JYP0322","Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by BICR, they will be given the opportunity to begin treatment with JYP0322 150mg tid. These subjects may continue treatment with JYP0322 if they are continuing to show clinical benefit until disease progression as judged by the investigator.",[15],{"type":21,"name":9,"description":30,"armGroupLabels":31,"otherNames":11},"JYP0322, 150 mg, administered orally three times daily (tid) after meals; sample size (N) = 60.",[9],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Li Zhang, M.D","CONTACT","86-020-87343458","zhangli@sysucc.org.cn",{"name":39,"role":35,"phone":40,"phoneExt":41,"email":42},"Danyang Liu, Master","86-020-22320385","+86","dyliu@joyopharma.com",{"type":44,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100604811","phase-3-jyp0322-versus-platinum-based-doublet-chemotherapy-in-ros1-positive-patients-previously-treated-with-ros1-tkis-100604811",false,"NCT07154368","JYP0322 Versus Platinum Based Doublet Chemotherapy in ROS1 Positive Patients Previously Treated With ROS1-TKIs.","A Randomized, Open-Label, Multicenter, Phase 3 Study Evaluating the Efficacy and Safety of JYP0322 Versus Platinum-Based Chemotherapy in ROS1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer Patients Previously Treated With ROS1-TKI Therapy.","Inclusion Criteria:\n\n* Key Inclusion Criteria\n\n  * Subjects with histologically or cytologically documented NSCLC.\n  * Locally advanced or metastatic ROS1 fusion positive NSCLC.\n  * Prior one or two ROS1-TKI(s) Treatment.\n  * World Health Organization (WHO) performance status 0-1.\n  * Life expectancy of at least 3 months.\n  * At least one measurable lesion according to RECISIT 1.1.\n\nExclusion Criteria:\n\n* Key Exclusion Criteria:\n\n  * Current participation in another therapeutic clinical trial.\n  * Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption.\n  * A history of severe allergies, or a history of severe allergy, hypersensitivity or other hypersensitivity to any active or inactive ingredient of the study drug.\n  * All acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade more than 1.\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  * Known active infe","ALL","18 Years",{"count":55,"type":56},207,"ESTIMATED","INTERVENTIONAL",[59],"PHASE3","The primary purpose of the study was to compare progression-free survival of JYP0322 vs. platinum-based doublet chemotherapy in patients previously treated with ROS1-TKIs. Patients in the chemotherapy arm are given the option to switch to JYP0322 after BICR confirmed progressive disease (PD), while also have the choice to pursue with other drugs after discussing with their physicians.",[62],"Non Small Cell Lung Cancer",[64],"Lung Cancer","NOT_YET_RECRUITING","2025-09-17",{"date":68,"type":69},"2025-09-19","ACTUAL",{"date":71,"type":56},"2025-09-23",{"date":73,"type":56},"2029-12-31",{"name":5,"class":6}]