[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581209":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":31,"responsibleParty":40,"collaborators":31,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":31,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":31,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":31},{"fullName":5,"class":6},"Shanghai Henlius Biotech","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"HLX17 group","EXPERIMENTAL","Recombinant anti-programmed death receptor-1- humanized antibody injection developed by Shanghai Henlius Biotech, Inc.",[13],"Drug: HLX17",{"label":15,"type":16,"description":17,"interventionNames":18},"US-sourced Keytruda® group","ACTIVE_COMPARATOR","US-sourced Keytruda",[19],"Drug: US-sourced Keytruda®",{"label":21,"type":16,"description":22,"interventionNames":23},"EU-sourced Keytruda® group","EU-sourced Keytruda",[24],"Drug: EU-sourced Keytruda®",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","HLX17","HLX17 will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"US-sourced Keytruda®","US-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed. After 24 weeks, all subjects in the US-Keytruda® group will receive HLX17 in combination with Pemetrexed until loss of clinical benefit or up to 1 year.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"EU-sourced Keytruda®","EU-sourced Keytruda® will be administered as IV infusion at a dose of 200mg on Day 1 of each 21-day cycle in combination with Carboplatin and Pemetrexed until loss of clinical benefit or up to 1 year.",[21],{"type":41,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100581209","phase-3-a-study-to-compare-the-efficacy-safety-immunogenicity-and-pharmacokinetic-profile-of-hlx17-vs-keytruda-in-the-first-line-treatment-of-advanced-non-squamous-non-small-cell-lung-cancer-100581209",false,"NCT06847334","A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX17 Vs. Keytruda® in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","A Multicentre, Randomized, Double-Blind, Parallel-Controlled Integrated Phase I\u002FIII Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetic Profile of HLX17 Vs. Keytruda® (US-sourced Keytruda® and EU-sourced Keytruda®) in the First-Line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV inoperable to surgery or radiotherapy (AJCC 8th edition) non-squamous NSCLC.\n* Without any tumor activating EGFR mutation or ALK or ROS1 gene rearrangement.\n* Have not received prior systemic treatment for their advanced\u002Fmetastatic NSCLC.\n* At least one measurable lesion as assessed by IRRC based on RECIST v1.1.\n* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Have adequate organ function.\n\nExclusion Criteria:\n\n* Subjects with NSCLC of other histopathological types, such as mixed adenosquamous carcinoma, and subjects with small cell lung cancer or neuroendocrine carcinoma.\n* Subjects with other active malignancies within 5 years or at the same time prior to screening.\n* Active central nervous system metastases.\n* Known interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and severe lung function abnormalities that may impede the investigators' diagnosis and management of drug-related pulmonary toxicity.\n* Known active or suspected autoimmune diseases.\n* History of immunodeficiency, including HIV antibody positive, active hepatitis B; or hepatitis C virus infections.\n* Have received pembrolizumab or any other immune checkpoints inhibitors (PD-1, PD-L1, CTLA4, etc.) before screening.\n* Pregnant or breastfeeding female.\n* The investigator has a clear reason to believe that participation in this study would be detrimental to the subject.","ALL","18 Years","75 Years",{"count":53,"type":54},772,"ESTIMATED","INTERVENTIONAL",[57],"PHASE3","This is a multicentre, randomized, double-blind, parallel-controlled integrated phase I\u002FIII clinical study to evaluate the similarity in efficacy, safety, PK profile, and immunogenicity of HLX17 vs. Keytruda®( US- and EU-sourced) in the first-line treatment of advanced non-squamous non-small cell lung cancer.",[60],"Non-Squamous Non-Small Cell Lung Cancer",[62],"Keytruda biosimilar","NOT_YET_RECRUITING","2025-02-21",{"date":66,"type":67},"2025-02-26","ACTUAL",{"date":69,"type":54},"2025-04-27",{"date":71,"type":54},"2028-01-24",{"name":5,"class":6}]