[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632414":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":41,"studyPopulation":41,"armGroups":53,"interventions":71,"overallOfficials":90,"centralContacts":94,"locations":100,"responsibleParty":1548,"collaborators":1550,"id":1553,"slug":1554,"hasResults":1555,"nctId":1556,"briefTitle":1557,"officialTitle":1558,"acronym":1559,"eligibilityCriteria":1560,"healthyVolunteers":1555,"sex":1561,"minAge":1562,"maxAge":41,"enrollmentInfo":1563,"targetDuration":41,"studyType":1566,"phases":1567,"briefSummary":1569,"conditions":1570,"keywords":41,"overallStatus":103,"whyStopped":41,"lastUpdateSubmitDate":1572,"lastUpdatePostDateStruct":1573,"startDateStruct":1576,"completionDateStruct":1578,"leadSponsor":1580,"locationsCount":1581},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C","DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.","Up to approximately 98 months",[14,16,20,24,28,31,35,38],{"measure":15,"description":11,"timeFrame":12},"DFS as Assessed by BICR",{"measure":17,"description":18,"timeFrame":19},"Distant Metastasis-Free Survival (DMFS)","DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.","Up to approximately 111 months",{"measure":21,"description":22,"timeFrame":23},"Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.","Up to approximately 123 months",{"measure":25,"description":26,"timeFrame":27},"Number Participants Who Experience an Adverse Events (AE)","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.","Up to approximately 144 months",{"measure":29,"description":30,"timeFrame":27},"Number of Participants Who Discontinue Study Treatment Due to an AE","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.",{"measure":32,"description":33,"timeFrame":34},"Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status \u002F Quality of Life (Items 29 & 30) Scale Combined Score","EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; \"How would you rate your overall health during the past week?\") and QoL (\"How would you rate your overall quality of life during the past week?\") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in global health status\u002Fquality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.","Baseline and up to approximately 36 months",{"measure":36,"description":37,"timeFrame":34},"Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score","EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.",{"measure":39,"description":40,"timeFrame":34},"Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score","EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions \"Were you limited in doing either your work or other daily activities during the past week?\" and \" Were you limited in pursuing your hobbies or other leisure time activities during the past week?\" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":41,"primaryPurpose":45,"observationalModel":41,"timePerspective":41,"maskingInfo":46},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":47,"maskingDescription":48,"whoMasked":49},"TRIPLE","Arm A - Open Label Arms B and C - Double Blind",[50,51,52],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[54,61,65],{"label":55,"type":56,"description":57,"interventionNames":58},"Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa","EXPERIMENTAL","Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.",[59,60],"Biological: Intismeran","Biological: Pembrolizumab coformulated with berahyaluronidase alfa",{"label":62,"type":56,"description":63,"interventionNames":64},"Arm B: 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Louis","Missouri","63110",{"type":110,"coordinates":177},[178,179],-90.19789,38.62727,{"lat":179,"lon":178},[182],{"name":117,"role":97,"phone":183,"phoneExt":41,"email":41},"314-362-5000",{"facility":185,"status":103,"city":186,"state":187,"zip":188,"country":107,"countryCode":108,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Billings Clinic ( Site 3255)","Billings","Montana","59101",{"type":110,"coordinates":190},[191,192],-108.50069,45.78329,{"lat":192,"lon":191},[195],{"name":117,"role":97,"phone":196,"phoneExt":41,"email":41},"406-435-7480",{"facility":198,"status":103,"city":199,"state":200,"zip":201,"country":107,"countryCode":108,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"NHO Revive Research Institute, LLC ( Site 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( Site 9000)","Albany","New York","12206",{"type":110,"coordinates":229},[230,231],-73.75623,42.65258,{"lat":231,"lon":230},[234],{"name":117,"role":97,"phone":235,"phoneExt":41,"email":41},"518-489-0044",{"facility":237,"status":103,"city":238,"state":226,"zip":239,"country":107,"countryCode":108,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"White Plains Hospital ( Site 3213)","White Plains","10601",{"type":110,"coordinates":241},[242,243],-73.76291,41.03399,{"lat":243,"lon":242},[246],{"name":117,"role":97,"phone":247,"phoneExt":41,"email":41},"914-849-7500",{"facility":249,"status":103,"city":250,"state":251,"zip":252,"country":107,"countryCode":108,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Charles George VA Medical Center ( Site 3233)","Asheville","North 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Dakota","57104",{"type":110,"coordinates":329},[330,331],-96.72796,43.54369,{"lat":331,"lon":330},[334],{"name":117,"role":97,"phone":335,"phoneExt":41,"email":41},"605-312-3250",{"facility":337,"status":103,"city":325,"state":326,"zip":338,"country":107,"countryCode":108,"cosmosGeoPoint":339,"geoPoint":341,"contacts":342},"Avera Cancer Institute ( Site 3209)","57105",{"type":110,"coordinates":340},[330,331],{"lat":331,"lon":330},[343],{"name":117,"role":97,"phone":344,"phoneExt":41,"email":41},"605-322-3000",{"facility":346,"status":103,"city":347,"state":348,"zip":349,"country":107,"countryCode":108,"cosmosGeoPoint":350,"geoPoint":354,"contacts":355},"The University of Tennessee Medical Center ( Site 3223)","Knoxville","Tennessee","37920",{"type":110,"coordinates":351},[352,353],-83.92074,35.96064,{"lat":353,"lon":352},[356],{"name":117,"role":97,"phone":357,"phoneExt":41,"email":41},"865-305-8780",{"facility":359,"status":103,"city":360,"state":361,"zip":362,"country":107,"countryCode":108,"cosmosGeoPoint":363,"geoPoint":367,"contacts":368},"Hematology Oncology Associates of Fredericksburg ( Site 3275)","Fredericksburg","Virginia","22408",{"type":110,"coordinates":364},[365,366],-77.46054,38.30318,{"lat":366,"lon":365},[369],{"name":117,"role":97,"phone":370,"phoneExt":41,"email":41},"540-371-0079",{"facility":372,"status":103,"city":373,"state":374,"zip":375,"country":107,"countryCode":108,"cosmosGeoPoint":376,"geoPoint":380,"contacts":381},"West Virginia University ( Site 3237)","Morgantown","West Virginia","26506",{"type":110,"coordinates":377},[378,379],-79.9559,39.62953,{"lat":379,"lon":378},[382],{"name":117,"role":97,"phone":383,"phoneExt":41,"email":41},"304-598-4500",{"facility":385,"status":103,"city":386,"state":387,"zip":388,"country":107,"countryCode":108,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"Gundersen Health System ( Site 3200)","La Crosse","Wisconsin","54601",{"type":110,"coordinates":390},[391,392],-91.23958,43.80136,{"lat":392,"lon":391},[395],{"name":117,"role":97,"phone":396,"phoneExt":41,"email":41},"608-775-2385",{"facility":398,"status":103,"city":399,"state":400,"zip":401,"country":402,"countryCode":403,"cosmosGeoPoint":404,"geoPoint":408,"contacts":409},"Royal North Shore Hospital ( Site 0502)","St Leonards","New South Wales","2065","Australia","AU",{"type":110,"coordinates":405},[406,407],151.19836,-33.82344,{"lat":407,"lon":406},[410],{"name":117,"role":97,"phone":411,"phoneExt":41,"email":41},"+61299267111",{"facility":413,"status":103,"city":414,"state":415,"zip":416,"country":402,"countryCode":403,"cosmosGeoPoint":417,"geoPoint":421,"contacts":422},"Princess Alexandra Hospital ( Site 0503)","Brisbane","Queensland","4102",{"type":110,"coordinates":418},[419,420],153.02809,-27.46794,{"lat":420,"lon":419},[423],{"name":117,"role":97,"phone":424,"phoneExt":41,"email":41},"0731762111",{"facility":426,"status":103,"city":427,"state":428,"zip":429,"country":402,"countryCode":403,"cosmosGeoPoint":430,"geoPoint":434,"contacts":435},"One Clinical Research ( Site 0501)","Nedlands","Western Australia","6009",{"type":110,"coordinates":431},[432,433],115.8073,-31.98184,{"lat":433,"lon":432},[436],{"name":117,"role":97,"phone":437,"phoneExt":41,"email":41},"+61410565868",{"facility":439,"status":103,"city":440,"state":441,"zip":442,"country":443,"countryCode":444,"cosmosGeoPoint":41,"geoPoint":41,"contacts":445},"Hospital de Clínicas de Passo Fundo ( Site 3601)","Pasos Fundo","Rio Grande do Sul","99010-260","Brazil","BR",[446],{"name":117,"role":97,"phone":447,"phoneExt":41,"email":41},"+5554981271411",{"facility":449,"status":103,"city":450,"state":41,"zip":451,"country":443,"countryCode":444,"cosmosGeoPoint":452,"geoPoint":456,"contacts":457},"Hospital Sírio Libanês ( Site 3611)","São Paulo","01308-060",{"type":110,"coordinates":453},[454,455],-46.63611,-23.5475,{"lat":455,"lon":454},[458],{"name":117,"role":97,"phone":459,"phoneExt":41,"email":41},"+5511994125414",{"facility":461,"status":103,"city":462,"state":463,"zip":464,"country":465,"countryCode":466,"cosmosGeoPoint":467,"geoPoint":471,"contacts":472},"Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)","Hamilton","Ontario","L8V 5C2","Canada","CA",{"type":110,"coordinates":468},[469,470],-79.84963,43.25011,{"lat":470,"lon":469},[473],{"name":117,"role":97,"phone":474,"phoneExt":41,"email":41},"905-387-9495",{"facility":476,"status":103,"city":477,"state":463,"zip":478,"country":465,"countryCode":466,"cosmosGeoPoint":479,"geoPoint":483,"contacts":484},"Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)","Kingston","K7L 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3E4",{"type":110,"coordinates":505},[506,507],-73.58781,45.50884,{"lat":507,"lon":506},[510],{"name":117,"role":97,"phone":511,"phoneExt":41,"email":41},"5148908000x26832",{"facility":513,"status":103,"city":514,"state":515,"zip":516,"country":517,"countryCode":518,"cosmosGeoPoint":519,"geoPoint":523,"contacts":524},"Clínica MEDS La Dehesa ( Site 3708)","Lo Barnechea","Region M. de Santiago","7691236","Chile","CL",{"type":110,"coordinates":520},[521,522],-70.51244,-33.36071,{"lat":522,"lon":521},[525],{"name":117,"role":97,"phone":526,"phoneExt":41,"email":41},"+56229015945",{"facility":528,"status":103,"city":529,"state":515,"zip":530,"country":517,"countryCode":518,"cosmosGeoPoint":531,"geoPoint":535,"contacts":536},"Centro de Oncología de Precisión ( Site 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Stage I NSCLC\n* Has provided a tissue sample from recent surgery along with the required blood sample\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs\n* Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has active infection requiring systemic therapy other than those permitted in protocol\n* Has history of stem cell\u002Fsolid organ transplant\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications","ALL","18 Years",{"count":1564,"type":1565},876,"ESTIMATED","INTERVENTIONAL",[1568],"PHASE3","Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.\n\nPeople with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. 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