[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542658":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":67,"armGroups":78,"interventions":92,"overallOfficials":112,"centralContacts":116,"locations":122,"responsibleParty":2756,"collaborators":67,"id":2758,"slug":2759,"hasResults":2760,"nctId":2761,"briefTitle":2762,"officialTitle":2763,"acronym":67,"eligibilityCriteria":2764,"healthyVolunteers":2760,"sex":2765,"minAge":2766,"maxAge":67,"enrollmentInfo":2767,"targetDuration":67,"studyType":2770,"phases":2771,"briefSummary":2773,"conditions":2774,"keywords":2776,"overallStatus":125,"whyStopped":67,"lastUpdateSubmitDate":2781,"lastUpdatePostDateStruct":2782,"startDateStruct":2785,"completionDateStruct":2787,"leadSponsor":2789,"locationsCount":2790},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":67},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","PFS is defined as the time from randomization until either documented disease progression per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PFS as determined by blinded independent central review (BICR) will be presented.","Up to approximately 42 months",{"measure":14,"description":15,"timeFrame":16},"Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.","Up to approximately 56 months",[18,21,24,27,30,34,37,40,43,46,49,52,55,58,61,64],{"measure":19,"description":20,"timeFrame":12},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.",{"measure":22,"description":23,"timeFrame":12},"Duration of Response (DOR)","For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.",{"measure":25,"description":26,"timeFrame":16},"Number of Participants Who Experience One or More Adverse Event (AEs)","An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.",{"measure":28,"description":29,"timeFrame":16},"Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)","An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.",{"measure":31,"description":32,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score","The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions \"How would you rate your overall health during the past week?\" and \"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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the score of EORTC QLQ-C30 Items 29 and 30 will be presented. Higher scores indicate a better overall health status.","Baseline and Up to approximately 24 months",{"measure":35,"description":36,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score","The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. Higher scores indicate a better level of functioning.",{"measure":38,"description":39,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score","The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. Higher scores indicate a better level of functioning.",{"measure":41,"description":42,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score","The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question \"Were you short of breath?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C30 Item 8 will be presented. A higher score indicates a worse level of dyspnea.",{"measure":44,"description":45,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score","The EORTC QLQ-C13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question \"Have you coughed?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 31 will be presented. A higher score indicates more frequent coughing.",{"measure":47,"description":48,"timeFrame":33},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-LC13) Chest pain (Item 40) Score","The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question \"Have you had pain in your chest?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). The change from baseline in the score of EORTC QLQ-C13 Item 40 will be presented. A higher score indicates a worse level of chest pain.",{"measure":50,"description":51,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in global health status (GHS) and quality of life (QoL) (EORTC QLQ-C30 Items 29 and 30) score. Participant responses to the questions \"How would you rate your overall health during the past week?\" and \"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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in GHS and QoL, will be presented. A longer TTD indicates a better outcome.",{"measure":53,"description":54,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Functioning (Items 1-5) Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in physical functioning score, will be presented. A longer TTD indicates a better outcome.",{"measure":56,"description":57,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Role Functioning (Items 6 and 7) Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.",{"measure":59,"description":60,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Dyspnea (Item 8) Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in dyspnea (EORTC QLQ-C30 Item 8) score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant response to the question \"Were you short of breath?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in dyspnea score, will be presented. A longer TTD indicates a better outcome.",{"measure":62,"description":63,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Cough (Item 31) Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in cough (EORTC QLQ-C13 Item 31) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question \"Have you coughed?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in cough score, will be presented. A longer TTD indicates a better outcome.",{"measure":65,"description":66,"timeFrame":33},"Time to Deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Lung Cancer-Specific Questionnaire Module (EORTC QLQ-C13) Chest pain (Item 40) Score","TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in chest pain (EORTC QLQ-C13 Item 40) score. The EORTC QLQ-C13 is lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant response to the question \"Have you had pain in your chest?\" is scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline chest pain score, will be presented. A longer TTD indicates a better outcome.",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":67,"primaryPurpose":71,"observationalModel":67,"timePerspective":67,"maskingInfo":72},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":73,"maskingDescription":67,"whoMasked":74},"TRIPLE",[75,76,77],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[79,86],{"label":80,"type":81,"description":82,"interventionNames":83},"Calderasib with Pembrolizumab","EXPERIMENTAL","Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and calderasib by oral tablets until discontinuation criterion is met.",[84,85],"Drug: Calderasib","Biological: Pembrolizumab",{"label":87,"type":88,"description":89,"interventionNames":90},"Placebo with Pembrolizumab","ACTIVE_COMPARATOR","Participants receive pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles and placebo by oral tablets once daily until discontinuation criterion is met.",[91,85],"Other: Placebo",[93,100,104],{"type":94,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"DRUG","Calderasib","Oral tablets",[80],[99],"MK-1084",{"type":101,"name":102,"description":96,"armGroupLabels":103,"otherNames":67},"OTHER","Placebo",[87],{"type":105,"name":106,"description":107,"armGroupLabels":108,"otherNames":109},"BIOLOGICAL","Pembrolizumab","IV infusion",[80,87],[110,111],"MK-3475","KEYTRUDA ®",[113],{"name":114,"affiliation":5,"role":115},"Medical Director","STUDY_DIRECTOR",[117],{"name":118,"role":119,"phone":120,"phoneExt":67,"email":121},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[123,141,153,166,177,190,203,215,228,241,254,267,276,289,302,315,322,328,340,353,362,377,390,403,416,431,443,458,471,484,497,510,522,534,547,559,568,583,596,608,620,629,644,657,670,682,695,707,722,735,744,753,762,777,790,798,807,816,829,838,851,863,876,885,894,907,919,932,945,954,967,976,989,996,1005,1017,1027,1036,1049,1062,1075,1087,1100,1109,1117,1130,1134,1139,1152,1161,1170,1182,1192,1205,1218,1227,1239,1251,1266,1279,1292,1305,1318,1331,1346,1353,1364,1373,1379,1388,1397,1403,1418,1431,1443,1458,1471,1480,1492,1505,1517,1526,1541,1550,1563,1572,1587,1600,1613,1626,1639,1648,1657,1667,1680,1692,1707,1719,1732,1740,1752,1764,1777,1790,1803,1816,1829,1842,1854,1867,1879,1887,1895,1907,1919,1928,1939,1951,1963,1975,1986,2000,2013,2025,2039,2051,2064,2076,2090,2105,2117,2125,2134,2146,2158,2171,2184,2197,2210,2224,2236,2249,2261,2273,2285,2294,2304,2317,2330,2343,2352,2365,2376,2388,2397,2406,2415,2430,2443,2456,2468,2477,2486,2495,2507,2521,2533,2545,2554,2563,2572,2584,2593,2605,2618,2631,2644,2657,2670,2683,2693,2702,2715,2728,2743],{"facility":124,"status":125,"city":126,"state":127,"zip":128,"country":129,"countryCode":130,"cosmosGeoPoint":131,"geoPoint":136,"contacts":137},"CBCC Global Research, Inc. ( Site 0123)","RECRUITING","Bakersfield","California","93309","United States","US",{"type":132,"coordinates":133},"Point",[134,135],-119.01871,35.37329,{"lat":135,"lon":134},[138],{"name":139,"role":119,"phone":140,"phoneExt":67,"email":67},"Study Coordinator","661-322-2206",{"facility":142,"status":125,"city":143,"state":127,"zip":144,"country":129,"countryCode":130,"cosmosGeoPoint":145,"geoPoint":149,"contacts":150},"Beverly Hills Cancer Center ( Site 0116)","Beverly Hills","90211",{"type":132,"coordinates":146},[147,148],-118.40036,34.07362,{"lat":148,"lon":147},[151],{"name":139,"role":119,"phone":152,"phoneExt":67,"email":67},"310-432-8955",{"facility":154,"status":125,"city":155,"state":156,"zip":157,"country":129,"countryCode":130,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Stamford Hospital ( Site 0136)","Stamford","Connecticut","06902",{"type":132,"coordinates":159},[160,161],-73.53873,41.05343,{"lat":161,"lon":160},[164],{"name":139,"role":119,"phone":165,"phoneExt":67,"email":67},"877-233-9355",{"facility":167,"status":168,"city":169,"state":170,"zip":171,"country":129,"countryCode":130,"cosmosGeoPoint":172,"geoPoint":176,"contacts":67},"Mount Sinai Cancer Center ( Site 0137)","COMPLETED","Miami Beach","Florida","33140",{"type":132,"coordinates":173},[174,175],-80.13005,25.79065,{"lat":175,"lon":174},{"facility":178,"status":125,"city":179,"state":180,"zip":181,"country":129,"countryCode":130,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Orchard Healthcare Research Inc. ( Site 0115)","Skokie","Illinois","60077",{"type":132,"coordinates":183},[184,185],-87.73339,42.03336,{"lat":185,"lon":184},[188],{"name":139,"role":119,"phone":189,"phoneExt":67,"email":67},"224-534-7580",{"facility":191,"status":125,"city":192,"state":193,"zip":194,"country":129,"countryCode":130,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"Truman Medical Center ( Site 0126)","Kansas City","Missouri","64108",{"type":132,"coordinates":196},[197,198],-94.57857,39.09973,{"lat":198,"lon":197},[201],{"name":139,"role":119,"phone":202,"phoneExt":67,"email":67},"816-404-4093",{"facility":204,"status":125,"city":205,"state":193,"zip":206,"country":129,"countryCode":130,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Cox Medical Center North ( Site 0133)","Springfield","65807",{"type":132,"coordinates":208},[209,210],-93.29824,37.21533,{"lat":210,"lon":209},[213],{"name":139,"role":119,"phone":214,"phoneExt":67,"email":67},"417-875-3000",{"facility":216,"status":125,"city":217,"state":218,"zip":219,"country":129,"countryCode":130,"cosmosGeoPoint":220,"geoPoint":224,"contacts":225},"St. Vincent Frontier Cancer Center-Research ( Site 0105)","Billings","Montana","59102",{"type":132,"coordinates":221},[222,223],-108.50069,45.78329,{"lat":223,"lon":222},[226],{"name":139,"role":119,"phone":227,"phoneExt":67,"email":67},"402-238-6685",{"facility":229,"status":125,"city":230,"state":231,"zip":232,"country":129,"countryCode":130,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Atlantic Health System Morristown Medical Center ( Site 0121)","Morristown","New Jersey","07960",{"type":132,"coordinates":234},[235,236],-74.48154,40.79677,{"lat":236,"lon":235},[239],{"name":139,"role":119,"phone":240,"phoneExt":67,"email":67},"973-275-7788",{"facility":242,"status":125,"city":243,"state":244,"zip":245,"country":129,"countryCode":130,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"New York Oncology Hematology, P.C. ( Site 0132)","Albany","New York","12206",{"type":132,"coordinates":247},[248,249],-73.75623,42.65258,{"lat":249,"lon":248},[252],{"name":139,"role":119,"phone":253,"phoneExt":67,"email":67},"518-489-3612",{"facility":255,"status":125,"city":256,"state":257,"zip":258,"country":129,"countryCode":130,"cosmosGeoPoint":259,"geoPoint":263,"contacts":264},"University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0103)","Cincinnati","Ohio","45219",{"type":132,"coordinates":260},[261,262],-84.51439,39.12711,{"lat":262,"lon":261},[265],{"name":139,"role":119,"phone":266,"phoneExt":67,"email":67},"513-556-6000",{"facility":268,"status":168,"city":269,"state":257,"zip":270,"country":129,"countryCode":130,"cosmosGeoPoint":271,"geoPoint":275,"contacts":67},"Kettering Health Main Campus-Kettering Health Cancer Center ( Site 0106)","Kettering","45429",{"type":132,"coordinates":272},[273,274],-84.16883,39.6895,{"lat":274,"lon":273},{"facility":277,"status":125,"city":278,"state":279,"zip":280,"country":129,"countryCode":130,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0134)","Lancaster","Pennsylvania","17601",{"type":132,"coordinates":282},[283,284],-76.30551,40.03788,{"lat":284,"lon":283},[287],{"name":139,"role":119,"phone":288,"phoneExt":67,"email":67},"717-544-9400",{"facility":290,"status":125,"city":291,"state":292,"zip":293,"country":129,"countryCode":130,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Oncology Consultants P.A. ( Site 0113)","Houston","Texas","77030",{"type":132,"coordinates":295},[296,297],-95.36327,29.76328,{"lat":297,"lon":296},[300],{"name":139,"role":119,"phone":301,"phoneExt":67,"email":67},"713-600-0900",{"facility":303,"status":125,"city":304,"state":305,"zip":306,"country":129,"countryCode":130,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Circuit Clinical\u002FSSM Health Dean Medical Group ( Site 0129)","Madison","Wisconsin","53715",{"type":132,"coordinates":308},[309,310],-89.40123,43.07305,{"lat":310,"lon":309},[313],{"name":139,"role":119,"phone":314,"phoneExt":67,"email":67},"608-410-2767",{"facility":316,"status":168,"city":317,"state":318,"zip":319,"country":320,"countryCode":321,"cosmosGeoPoint":67,"geoPoint":67,"contacts":67},"AUSTRAL MEDICAL CENTER ( Site 0302)","CABA","Buenos Aires","C1019ABS","Argentina","AR",{"facility":323,"status":125,"city":317,"state":318,"zip":324,"country":320,"countryCode":321,"cosmosGeoPoint":67,"geoPoint":67,"contacts":325},"Centro Oncologico Korben ( Site 0304)","C1426AGE",[326],{"name":139,"role":119,"phone":327,"phoneExt":67,"email":67},"1157507952",{"facility":329,"status":125,"city":330,"state":318,"zip":331,"country":320,"countryCode":321,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Instituto de Investigaciones Clínicas Mar del Plata ( Site 0300)","Mar del Plata","B7600FZO",{"type":132,"coordinates":333},[334,335],-57.5562,-38.00042,{"lat":335,"lon":334},[338],{"name":139,"role":119,"phone":339,"phoneExt":67,"email":67},"02234963224",{"facility":341,"status":125,"city":342,"state":343,"zip":344,"country":320,"countryCode":321,"cosmosGeoPoint":345,"geoPoint":349,"contacts":350},"Fundacion Estudios Clinicos ( Site 0306)","Rosario","Santa Fe Province","S2000DEJ",{"type":132,"coordinates":346},[347,348],-60.63932,-32.94682,{"lat":348,"lon":347},[351],{"name":139,"role":119,"phone":352,"phoneExt":67,"email":67},"+543412221472",{"facility":354,"status":125,"city":342,"state":343,"zip":355,"country":320,"countryCode":321,"cosmosGeoPoint":356,"geoPoint":358,"contacts":359},"Sanatorio Parque ( Site 0301)","S2000DSV",{"type":132,"coordinates":357},[347,348],{"lat":348,"lon":347},[360],{"name":139,"role":119,"phone":361,"phoneExt":67,"email":67},"+54341420-0222",{"facility":363,"status":125,"city":364,"state":365,"zip":366,"country":367,"countryCode":368,"cosmosGeoPoint":369,"geoPoint":373,"contacts":374},"Chris O'Brien Lifehouse ( Site 3000)","Camperdown","New South Wales","2050","Australia","AU",{"type":132,"coordinates":370},[371,372],151.17642,-33.88965,{"lat":372,"lon":371},[375],{"name":139,"role":119,"phone":376,"phoneExt":67,"email":67},"+61285140140",{"facility":378,"status":125,"city":379,"state":380,"zip":381,"country":367,"countryCode":368,"cosmosGeoPoint":382,"geoPoint":386,"contacts":387},"Cancer Care Service Hervey Bay ( Site 3003)","Urraween","Queensland","4655",{"type":132,"coordinates":383},[384,385],152.82206,-25.29522,{"lat":385,"lon":384},[388],{"name":139,"role":119,"phone":389,"phoneExt":67,"email":67},"+610743256110",{"facility":391,"status":125,"city":392,"state":393,"zip":394,"country":367,"countryCode":368,"cosmosGeoPoint":395,"geoPoint":399,"contacts":400},"Frankston Hospital ( Site 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80",{"facility":2555,"status":125,"city":2535,"state":67,"zip":2556,"country":2512,"countryCode":67,"cosmosGeoPoint":2557,"geoPoint":2559,"contacts":2560},"Memorial Ankara Hastanesi-Medical Oncology ( Site 2106)","06520",{"type":132,"coordinates":2558},[2539,2540],{"lat":2540,"lon":2539},[2561],{"name":139,"role":119,"phone":2562,"phoneExt":67,"email":67},"+903122536666",{"facility":2564,"status":125,"city":2535,"state":67,"zip":2565,"country":2512,"countryCode":67,"cosmosGeoPoint":2566,"geoPoint":2568,"contacts":2569},"Ankara Bilkent Şehir Hastanesi ( Site 2100)","06800",{"type":132,"coordinates":2567},[2539,2540],{"lat":2540,"lon":2539},[2570],{"name":139,"role":119,"phone":2571,"phoneExt":67,"email":67},"+903125526000",{"facility":2573,"status":125,"city":2574,"state":67,"zip":2575,"country":2512,"countryCode":67,"cosmosGeoPoint":2576,"geoPoint":2580,"contacts":2581},"Medipol Mega Universite Hastanesi-oncology ( Site 2105)","Istanbul","34214",{"type":132,"coordinates":2577},[2578,2579],28.94966,41.01384,{"lat":2579,"lon":2578},[2582],{"name":139,"role":119,"phone":2583,"phoneExt":67,"email":67},"+902124447044",{"facility":2585,"status":125,"city":2574,"state":67,"zip":2586,"country":2512,"countryCode":67,"cosmosGeoPoint":2587,"geoPoint":2589,"contacts":2590},"TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2103)","34722",{"type":132,"coordinates":2588},[2578,2579],{"lat":2579,"lon":2578},[2591],{"name":139,"role":119,"phone":2592,"phoneExt":67,"email":67},"+902166065200",{"facility":2594,"status":991,"city":2595,"state":2596,"zip":2597,"country":2598,"countryCode":2599,"cosmosGeoPoint":2600,"geoPoint":2604,"contacts":67},"COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 2209)","Cherkasy","Cherkasy Oblast","18009","Ukraine","UA",{"type":132,"coordinates":2601},[2602,2603],32.05738,49.44452,{"lat":2603,"lon":2602},{"facility":2606,"status":125,"city":2607,"state":2608,"zip":2609,"country":2598,"countryCode":2599,"cosmosGeoPoint":2610,"geoPoint":2614,"contacts":2615},"Regional Municipal Non-profit Enterprise \"Bukovinian Clinical Oncology Center\" ( Site 2210)","Chernivtsi","Chernivetska Oblast","58013",{"type":132,"coordinates":2611},[2612,2613],25.93241,48.29045,{"lat":2613,"lon":2612},[2616],{"name":139,"role":119,"phone":2617,"phoneExt":67,"email":67},"+380955077568",{"facility":2619,"status":125,"city":2620,"state":2621,"zip":2622,"country":2598,"countryCode":2599,"cosmosGeoPoint":2623,"geoPoint":2627,"contacts":2628},"Medical Center \"Mriya Med-Service\"-Clinical Research Department ( Site 2215)","Kryvyi Rih","Dnipropetrovsk Oblast","50000",{"type":132,"coordinates":2624},[2625,2626],33.39404,47.90572,{"lat":2626,"lon":2625},[2629],{"name":139,"role":119,"phone":2630,"phoneExt":67,"email":67},"+380973567855",{"facility":2632,"status":125,"city":2633,"state":2634,"zip":2635,"country":2598,"countryCode":2599,"cosmosGeoPoint":2636,"geoPoint":2640,"contacts":2641},"Communal Non-Commercial Enterprise \"Prykarpatski Clinical On-Surgery department #2 ( Site 2202)","Ivano-Frankivsk","Ivano-Frankivsk Oblast","76018",{"type":132,"coordinates":2637},[2638,2639],24.71248,48.92312,{"lat":2639,"lon":2638},[2642],{"name":139,"role":119,"phone":2643,"phoneExt":67,"email":67},"+380978411455",{"facility":2645,"status":125,"city":2646,"state":2647,"zip":2648,"country":2598,"countryCode":2599,"cosmosGeoPoint":2649,"geoPoint":2653,"contacts":2654},"Kirovohrad Regional Oncology Center-Chemotherapy department ( Site 2204)","Kropyvnytskyi","Kirovohrad Oblast","25011",{"type":132,"coordinates":2650},[2651,2652],32.26618,48.50834,{"lat":2652,"lon":2651},[2655],{"name":139,"role":119,"phone":2656,"phoneExt":67,"email":67},"+380508412400",{"facility":2658,"status":125,"city":2659,"state":2660,"zip":2661,"country":2598,"countryCode":2599,"cosmosGeoPoint":2662,"geoPoint":2666,"contacts":2667},"Medical Center \"MedOffice Group\" ( Site 2219)","Kiev","Kyivska Oblast","03022",{"type":132,"coordinates":2663},[2664,2665],30.5238,50.45466,{"lat":2665,"lon":2664},[2668],{"name":139,"role":119,"phone":2669,"phoneExt":67,"email":67},"+380503858689",{"facility":2671,"status":125,"city":2672,"state":2673,"zip":2674,"country":2598,"countryCode":2599,"cosmosGeoPoint":2675,"geoPoint":2679,"contacts":2680},"Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2217)","Lviv","Lviv Oblast","79059",{"type":132,"coordinates":2676},[2677,2678],24.02324,49.83826,{"lat":2678,"lon":2677},[2681],{"name":139,"role":119,"phone":2682,"phoneExt":67,"email":67},"+380506749772",{"facility":2684,"status":168,"city":2685,"state":2686,"zip":2687,"country":2598,"countryCode":2599,"cosmosGeoPoint":2688,"geoPoint":2692,"contacts":67},"Rivne Regional Clinical Hospital ( Site 2205)","Rivne","Rivne Oblast","33007",{"type":132,"coordinates":2689},[2690,2691],26.23695,50.62036,{"lat":2691,"lon":2690},{"facility":2694,"status":125,"city":2685,"state":2686,"zip":2695,"country":2598,"countryCode":2599,"cosmosGeoPoint":2696,"geoPoint":2698,"contacts":2699},"ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2920)","33010",{"type":132,"coordinates":2697},[2690,2691],{"lat":2691,"lon":2690},[2700],{"name":139,"role":119,"phone":2701,"phoneExt":67,"email":67},"+380362633075",{"facility":2703,"status":125,"city":2704,"state":2705,"zip":2706,"country":2598,"countryCode":2599,"cosmosGeoPoint":2707,"geoPoint":2711,"contacts":2712},"Communal Noncommercial Enterprise \"Podillia Regional Oncolog-Cardiothoracic department ( Site 2211)","Vinnytsia","Vinnytsia Oblast","21029",{"type":132,"coordinates":2708},[2709,2710],28.46871,49.2322,{"lat":2710,"lon":2709},[2713],{"name":139,"role":119,"phone":2714,"phoneExt":67,"email":67},"+380953105783",{"facility":2716,"status":125,"city":2717,"state":2718,"zip":2719,"country":2598,"countryCode":2599,"cosmosGeoPoint":2720,"geoPoint":2724,"contacts":2725},"ME Volyn Regional Clinical Hospital of the Volyn Regional Council ( Site 2216)","Lutsk","Volyn Oblast","43018",{"type":132,"coordinates":2721},[2722,2723],25.35024,50.75784,{"lat":2723,"lon":2722},[2726],{"name":139,"role":119,"phone":2727,"phoneExt":67,"email":67},"+380503782998",{"facility":2729,"status":125,"city":2730,"state":2731,"zip":2732,"country":2733,"countryCode":2734,"cosmosGeoPoint":2735,"geoPoint":2739,"contacts":2740},"Milton Keynes Hospital ( Site 2304)","Milton Keynes","Buckinghamshire","MK6 5LD","United Kingdom","UK",{"type":132,"coordinates":2736},[2737,2738],-0.75583,52.04172,{"lat":2738,"lon":2737},[2741],{"name":139,"role":119,"phone":2742,"phoneExt":67,"email":67},"01908 997609",{"facility":2744,"status":125,"city":2745,"state":2746,"zip":2747,"country":2733,"countryCode":2734,"cosmosGeoPoint":2748,"geoPoint":2752,"contacts":2753},"Royal Devon & Exeter Hospital-Oncology ( Site 2302)","Exeter","Devon","EX2 5DW",{"type":132,"coordinates":2749},[2750,2751],-3.52751,50.7236,{"lat":2751,"lon":2750},[2754],{"name":139,"role":119,"phone":2755,"phoneExt":67,"email":67},"+44 (0) 1392 402869",{"type":2757,"investigatorFullName":67,"investigatorTitle":67,"investigatorAffiliation":67,"oldNameTitle":67,"oldOrganization":67},"SPONSOR","100542658","phase-3-a-study-of-calderasib-mk-1084-plus-pembrolizumab-mk-3475-in-participants-with-kras-g12c-mutant-non-small-cell-lung-cancer-nsclc-with-programmed-cell-death-ligand-1-pd-l1-tumor-proportion-score-tps-50-mk-1084-004kandlelit-004-100542658",false,"NCT06345729","A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004\u002FKANDLELIT-004)","A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)\n* Has newly diagnosed Stage IIIB\u002FIIIC NSCLC, not eligible for curative resection or curative chemotherapy\u002Fradiation as determined by a multidisciplinary tumor board and\u002For by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8\n* Provides an archival tumor tissue sample (≤5 years) or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, PD-L1 status, and biomarker research\n* If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \\\u003C Grade 1 or baseline\n* If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)\n* If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n* Has known history of, or active, neurologic paraneoplastic syndrome\n* Has an active infection requiring systemic therapy, with exceptions\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has one or more of the following ophthalmological findings\u002Fconditions: intraocular pressure \\>21 mmHg and\u002For any diagnosis of glaucoma, diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion, diagnosis of retinal degenerative disease\n* Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC\n* Has received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Has received radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* 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\n* Has history of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Is HIV-infected and has a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has history of allogenic tissue\u002Fsolid organ transplant\n* Has not fully recovered from any effects of major surgical procedure","ALL","18 Years",{"count":2768,"type":2769},600,"ESTIMATED","INTERVENTIONAL",[2772],"PHASE3","This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There are two primary study hypotheses:\n\nHypothesis 1: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).\n\nHypothesis 2: Combination of calderasib plus pembrolizumab is superior to placebo plus pembrolizumab with respect to overall survival (OS).",[2775],"Non-small Cell Lung Cancer",[2777,2778,2779,2780],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C)","2026-09-04",{"date":2783,"type":2784},"2026-09-08","ACTUAL",{"date":2786,"type":2784},"2024-05-24",{"date":2788,"type":2769},"2031-02-18",{"name":5,"class":6},225]