[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532434":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":79,"centralContacts":52,"locations":83,"responsibleParty":235,"collaborators":52,"id":237,"slug":238,"hasResults":239,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":52,"eligibilityCriteria":243,"healthyVolunteers":244,"sex":245,"minAge":246,"maxAge":52,"enrollmentInfo":247,"targetDuration":52,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":52,"overallStatus":256,"whyStopped":52,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":265,"locationsCount":266},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy","EXPERIMENTAL","Japanese participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated with Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for18 cycles (up to approximately108 weeks) in combination with platinum doublet chemotherapy.",[13,14,15,16,17,18,19,20],"Biological: Pembrolizumab (+) Berahyaluronidase alfa","Drug: Pemetrexed","Drug: Cisplatin","Drug: Carboplatin","Drug: Paclitaxel","Drug: Nab-paclitaxel","Drug: Filgrastim","Drug: Pegylated filgrastim",{"label":22,"type":23,"description":24,"interventionNames":25},"Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy","ACTIVE_COMPARATOR","Japanese participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.",[14,15,16,17,18,26,19,20],"Biological: Pembrolizumab",[28,35,42,48,53,59,65,71,75],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BIOLOGICAL","Pembrolizumab (+) Berahyaluronidase alfa","Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.",[9],[34],"MK-3475A",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Pemetrexed","Pemetrexed 500 mg\u002Fm² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.",[9,22],[41],"Alimta",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Cisplatin","Cisplatin 75 mg\u002Fm² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.",[9,22],[47],"Platinol-AQ",{"type":36,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Carboplatin","Carboplatin AUC 5 mg\u002FmL\u002Fmin in nonsquamous and AUC 6 mg\u002FmL\u002Fmin in squamous NSCLC will be administered as per the schedule specified in arm.",[9,22],null,{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Paclitaxel","Paclitaxel 200 mg\u002Fm² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.",[9,22],[58],"Taxol",{"type":36,"name":60,"description":61,"armGroupLabels":62,"otherNames":63},"Nab-paclitaxel","Nab-paclitaxel 100 mg\u002Fm² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.",[9,22],[64],"Albumin-bound paclitaxel",{"type":29,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Pembrolizumab","Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.",[22],[70],"MK-3475, KEYTRUDA",{"type":36,"name":72,"description":73,"armGroupLabels":74,"otherNames":52},"Filgrastim","Filgrastim will be administered as per the schedule specified for the arm.",[9,22],{"type":36,"name":76,"description":77,"armGroupLabels":78,"otherNames":52},"Pegylated filgrastim","Pegylated filgrastim will be administered as per the schedule specified for the arm.",[9,22],[80],{"name":81,"affiliation":5,"role":82},"Medical Director","STUDY_DIRECTOR",[84,97,107,112,122,132,142,151,161,171,180,185,190,200,205,213,219,227],{"facility":85,"status":52,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":52},"Fujita Health University ( Site 4406)","Toyoake","Aichi-ken","470-1192","Japan","JP",{"type":92,"coordinates":93},"Point",[94,95],136.99931,35.038,{"lat":95,"lon":94},{"facility":98,"status":52,"city":99,"state":100,"zip":101,"country":89,"countryCode":90,"cosmosGeoPoint":102,"geoPoint":106,"contacts":52},"Kurume University Hospital ( Site 4412)","Kurume","Fukuoka","830-0011",{"type":92,"coordinates":103},[104,105],130.51667,33.31667,{"lat":105,"lon":104},{"facility":108,"status":52,"city":109,"state":110,"zip":111,"country":89,"countryCode":90,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"Gunma Prefectural Cancer Center ( Site 4416)","Otashi","Gunma","373-8550",{"facility":113,"status":52,"city":114,"state":115,"zip":116,"country":89,"countryCode":90,"cosmosGeoPoint":117,"geoPoint":121,"contacts":52},"National Hospital Organization Hokkaido Cancer Center ( Site 4415)","Sapporo","Hokkaido","003-0804",{"type":92,"coordinates":118},[119,120],141.35,43.06667,{"lat":120,"lon":119},{"facility":123,"status":52,"city":124,"state":125,"zip":126,"country":89,"countryCode":90,"cosmosGeoPoint":127,"geoPoint":131,"contacts":52},"Kanagawa Cardiovascular and Respiratory Center ( Site 4404)","Yokohama","Kanagawa","236-0051",{"type":92,"coordinates":128},[129,130],139.65,35.43333,{"lat":130,"lon":129},{"facility":133,"status":52,"city":134,"state":135,"zip":136,"country":89,"countryCode":90,"cosmosGeoPoint":137,"geoPoint":141,"contacts":52},"Miyagi Cancer Center ( Site 4401)","Natori-shi","Miyagi","981-1293",{"type":92,"coordinates":138},[139,140],140.88333,38.16667,{"lat":140,"lon":139},{"facility":143,"status":52,"city":144,"state":135,"zip":145,"country":89,"countryCode":90,"cosmosGeoPoint":146,"geoPoint":150,"contacts":52},"Sendai Kousei Hospital ( Site 4400)","Sendai","9800873",{"type":92,"coordinates":147},[148,149],140.86667,38.26667,{"lat":149,"lon":148},{"facility":152,"status":52,"city":153,"state":154,"zip":155,"country":89,"countryCode":90,"cosmosGeoPoint":156,"geoPoint":160,"contacts":52},"Kurashiki Central Hospital ( Site 4409)","Kurashiki","Okayama-ken","710-8602",{"type":92,"coordinates":157},[158,159],133.76667,34.58333,{"lat":159,"lon":158},{"facility":162,"status":52,"city":163,"state":164,"zip":165,"country":89,"countryCode":90,"cosmosGeoPoint":166,"geoPoint":170,"contacts":52},"Kansai Medical University Hospital ( Site 4408)","Hirakata","Osaka","573-1191",{"type":92,"coordinates":167},[168,169],135.64914,34.81352,{"lat":169,"lon":168},{"facility":172,"status":52,"city":173,"state":164,"zip":174,"country":89,"countryCode":90,"cosmosGeoPoint":175,"geoPoint":179,"contacts":52},"Osaka Medical and Pharmaceutical University Hospital ( Site 4414)","Takatsuki","569-8686",{"type":92,"coordinates":176},[177,178],135.61678,34.84833,{"lat":178,"lon":177},{"facility":181,"status":52,"city":182,"state":183,"zip":184,"country":89,"countryCode":90,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"Saitama Prefectural Cancer Center ( Site 4402)","Ina-machi","Saitama","362-0806",{"facility":186,"status":52,"city":187,"state":188,"zip":189,"country":89,"countryCode":90,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"Shizuoka Cancer Center ( Site 4405)","Nagaizumi-cho,Sunto-gun","Shizuoka","411-8777",{"facility":191,"status":52,"city":192,"state":193,"zip":194,"country":89,"countryCode":90,"cosmosGeoPoint":195,"geoPoint":199,"contacts":52},"Tochigi Cancer Center ( Site 4417)","Utsunomiya","Tochigi","320-0834",{"type":92,"coordinates":196},[197,198],139.88333,36.56667,{"lat":198,"lon":197},{"facility":201,"status":52,"city":202,"state":203,"zip":204,"country":89,"countryCode":90,"cosmosGeoPoint":52,"geoPoint":52,"contacts":52},"Juntendo University Hospital ( Site 4413)","Bunkyo-ku","Tokyo","1138431",{"facility":206,"status":52,"city":100,"state":52,"zip":207,"country":89,"countryCode":90,"cosmosGeoPoint":208,"geoPoint":212,"contacts":52},"National Hospital Organization Kyushu Medical Center ( Site 4411)","810-8563",{"type":92,"coordinates":209},[210,211],130.41667,33.6,{"lat":211,"lon":210},{"facility":214,"status":52,"city":100,"state":52,"zip":215,"country":89,"countryCode":90,"cosmosGeoPoint":216,"geoPoint":218,"contacts":52},"National Hospital Organization Kyushu Cancer Center ( Site 4410)","811-1395",{"type":92,"coordinates":217},[210,211],{"lat":211,"lon":210},{"facility":220,"status":52,"city":164,"state":52,"zip":221,"country":89,"countryCode":90,"cosmosGeoPoint":222,"geoPoint":226,"contacts":52},"Osaka International Cancer Institute ( Site 4407)","541-8567",{"type":92,"coordinates":223},[224,225],135.50107,34.69379,{"lat":225,"lon":224},{"facility":228,"status":52,"city":203,"state":52,"zip":229,"country":89,"countryCode":90,"cosmosGeoPoint":230,"geoPoint":234,"contacts":52},"Nippon Medical School Hospital ( Site 4403)","113-8603",{"type":92,"coordinates":231},[232,233],139.69171,35.6895,{"lat":233,"lon":232},{"type":236,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100532434","phase-3-a-study-of-subcutaneous-sc-pembrolizumab-coformulated-with-berahyaluronidase-alfa-mk-3475a-vs-intravenous-pembrolizumab-in-adult-participants-with-metastatic-non-small-cell-lung-cancer-nsclc-mk-3475a-d77-japan-extension-100532434",true,"NCT06212752","A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension","A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer","The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)\n* Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated\n* Has a life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has received prior systemic anticancer therapy for metastatic NSCLC\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids\n* Has received radiation therapy to the lung (\\>30 Gray) within 6 months of start of study intervention\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has an active autoimmune disease that has required systemic treatment in past 2 years\n* Has an active infection requiring systemic therapy\n* Has a history of human immunodeficiency virus (HIV) infection\n* Has a history of Hepatitis B or C\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* Has a history of allogenic tissue\u002Fsolid organ transplant",false,"ALL","18 Years",{"count":248,"type":249},39,"ACTUAL","INTERVENTIONAL",[252],"PHASE3","This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.",[255],"Metastatic Non-small Cell Lung Cancer","ACTIVE_NOT_RECRUITING","2025-10-22",{"date":259,"type":249},"2025-11-12",{"date":261,"type":249},"2023-06-13",{"date":263,"type":264},"2028-05-22","ESTIMATED",{"name":5,"class":6},18]