[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635565":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":43,"studyPopulation":43,"armGroups":54,"interventions":68,"overallOfficials":88,"centralContacts":92,"locations":98,"responsibleParty":307,"collaborators":43,"id":309,"slug":43,"hasResults":310,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":43,"eligibilityCriteria":314,"healthyVolunteers":310,"sex":315,"minAge":316,"maxAge":43,"enrollmentInfo":317,"targetDuration":43,"studyType":320,"phases":321,"briefSummary":323,"conditions":324,"keywords":43,"overallStatus":101,"whyStopped":43,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":335},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.","Up to approximately 6 years",[14,18,21,24,27,30,33,37,40],{"measure":15,"description":16,"timeFrame":17},"Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.","Up to approximately 9 years",{"measure":19,"description":20,"timeFrame":17},"Number of Participants Who Experience an Adverse Events (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":22,"description":23,"timeFrame":17},"Number of Participants Who Discontinue Study Treatment Due to an 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":25,"description":26,"timeFrame":17},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.",{"measure":28,"description":29,"timeFrame":17},"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":31,"description":32,"timeFrame":17},"Distant Metastasis-Free Survival (DMFS)","DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread beyond the original (primary) tumor\u002Fregional metastases to distant organs or distant lymph nodes.",{"measure":34,"description":35,"timeFrame":36},"Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)\u002FQuality of Life (QoL) (Items 29 & 30) 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 GHS and QoL combined score will be presented.","Baseline and up to approximately 9 years",{"measure":38,"description":39,"timeFrame":36},"Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined 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":41,"description":42,"timeFrame":36},"Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score","The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be reported.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":49,"maskingDescription":43,"whoMasked":50},"TRIPLE",[51,52,53],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[55,62],{"label":56,"type":57,"description":58,"interventionNames":59},"Calderasib + Durvalumab","EXPERIMENTAL","Participants will receive calderasib and durvalumab.",[60,61],"Drug: Calderasib","Biological: Durvalumab",{"label":63,"type":64,"description":65,"interventionNames":66},"Placebo + Durvalumab","ACTIVE_COMPARATOR","Participants will receive placebo to calderasib and durvalumab.",[61,67],"Other: Placebo to MK-1084",[69,76,83],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":74},"DRUG","Calderasib","Tablet for oral administration.",[56],[75],"MK-1084",{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"BIOLOGICAL","Durvalumab","Solution for intravenous (IV) infusion.",[56,63],[82],"IMFINZI®",{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":43},"OTHER","Placebo to MK-1084","Placebo to MK-1084.",[63],[89],{"name":90,"affiliation":5,"role":91},"Medical Director","STUDY_DIRECTOR",[93],{"name":94,"role":95,"phone":96,"phoneExt":43,"email":97},"Toll Free Number","CONTACT","1-888-577-8839","Trialsites@msd.com",[99,117,131,144,156,165,179,194,207,220,233,242,255,268,281,294],{"facility":100,"status":101,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"NHO Revive Research Institute LLC ( Site 0118)","RECRUITING","Lincoln","Nebraska","68506","United States","US",{"type":108,"coordinates":109},"Point",[110,111],-96.66696,40.8,{"lat":111,"lon":110},[114],{"name":115,"role":95,"phone":116,"phoneExt":43,"email":43},"Study Coordinator","402-484-4900",{"facility":118,"status":101,"city":119,"state":120,"zip":121,"country":122,"countryCode":43,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Ajou University Hospital ( Site 2504)","Suwon","Kyonggi-do","16499","South Korea",{"type":108,"coordinates":124},[125,126],127.00889,37.29111,{"lat":126,"lon":125},[129],{"name":115,"role":95,"phone":130,"phoneExt":43,"email":43},"+8216886114",{"facility":132,"status":101,"city":133,"state":134,"zip":135,"country":122,"countryCode":43,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Keimyung University Dongsan Hospital ( Site 2503)","Daegu","Taegu-Kwangyokshi","42601",{"type":108,"coordinates":137},[138,139],128.59111,35.87028,{"lat":139,"lon":138},[142],{"name":115,"role":95,"phone":143,"phoneExt":43,"email":43},"+82532586671",{"facility":145,"status":101,"city":146,"state":43,"zip":147,"country":122,"countryCode":43,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Severance Hospital, Yonsei University Health System ( Site 2501)","Seoul","03722",{"type":108,"coordinates":149},[150,151],126.9784,37.566,{"lat":151,"lon":150},[154],{"name":115,"role":95,"phone":155,"phoneExt":43,"email":43},"82-2-2228-0831",{"facility":157,"status":101,"city":146,"state":43,"zip":158,"country":122,"countryCode":43,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"Asan Medical Center ( Site 2500)","05505",{"type":108,"coordinates":160},[150,151],{"lat":151,"lon":150},[163],{"name":115,"role":95,"phone":164,"phoneExt":43,"email":43},"+82230103214",{"facility":166,"status":101,"city":167,"state":43,"zip":168,"country":169,"countryCode":170,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"National Cheng Kung University Hospital ( Site 2601)","Tainan","704","Taiwan","TW",{"type":108,"coordinates":172},[173,174],120.21333,22.99083,{"lat":174,"lon":173},[177],{"name":115,"role":95,"phone":178,"phoneExt":43,"email":43},"+886-6-2353535#3120",{"facility":180,"status":101,"city":181,"state":182,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Regional Municipal Non-profit Enterprise \"Bukovinian Clinical Oncology Center\" ( Site 2002)","Chernivtsi","Chernivetska Oblast","58013","Ukraine","UA",{"type":108,"coordinates":187},[188,189],25.93241,48.29045,{"lat":189,"lon":188},[192],{"name":115,"role":95,"phone":193,"phoneExt":43,"email":43},"+380505144910",{"facility":195,"status":101,"city":196,"state":197,"zip":198,"country":184,"countryCode":185,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Medical Center \"Mriya Med-Service\"-Clinical Research Department ( Site 2012)","Kryvyi Rih","Dnipropetrovsk Oblast","50000",{"type":108,"coordinates":200},[201,202],33.39404,47.90572,{"lat":202,"lon":201},[205],{"name":115,"role":95,"phone":206,"phoneExt":43,"email":43},"+380973567855",{"facility":208,"status":101,"city":209,"state":210,"zip":211,"country":184,"countryCode":185,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Communal Non-Commercial Enterprise \"Prykarpatski Clinical Oncological Center\" of Ivano-Frankivsk Reg ( Site 2006)","Ivano-Frankivsk","Ivano-Frankivsk Oblast","76018",{"type":108,"coordinates":213},[214,215],24.71248,48.92312,{"lat":215,"lon":214},[218],{"name":115,"role":95,"phone":219,"phoneExt":43,"email":43},"+380342540325",{"facility":221,"status":101,"city":222,"state":223,"zip":224,"country":184,"countryCode":185,"cosmosGeoPoint":225,"geoPoint":229,"contacts":230},"Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)","Kropyvnytskyi","Kirovohrad Oblast","25006",{"type":108,"coordinates":226},[227,228],32.26618,48.50834,{"lat":228,"lon":227},[231],{"name":115,"role":95,"phone":232,"phoneExt":43,"email":43},"+380969680396",{"facility":234,"status":101,"city":222,"state":223,"zip":235,"country":184,"countryCode":185,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"Ukrainian Center of Tomotherapy ( Site 2014)","25011",{"type":108,"coordinates":237},[227,228],{"lat":228,"lon":227},[240],{"name":115,"role":95,"phone":241,"phoneExt":43,"email":43},"+380676239652",{"facility":243,"status":101,"city":244,"state":245,"zip":246,"country":184,"countryCode":185,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Shalimov Institute of Surgery and Transplantation ( Site 2003)","Kyiv","Kyivska Oblast","03680",{"type":108,"coordinates":248},[249,250],30.5238,50.45466,{"lat":250,"lon":249},[253],{"name":115,"role":95,"phone":254,"phoneExt":43,"email":43},"+380933333911",{"facility":256,"status":101,"city":257,"state":258,"zip":259,"country":184,"countryCode":185,"cosmosGeoPoint":260,"geoPoint":264,"contacts":265},"Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)","Odesa","Odesa Oblast","65025",{"type":108,"coordinates":261},[262,263],30.74383,46.48572,{"lat":263,"lon":262},[266],{"name":115,"role":95,"phone":267,"phoneExt":43,"email":43},"+380972147211",{"facility":269,"status":101,"city":270,"state":271,"zip":272,"country":184,"countryCode":185,"cosmosGeoPoint":273,"geoPoint":277,"contacts":278},"ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)","Rivne","Rivne Oblast","33010",{"type":108,"coordinates":274},[275,276],26.23695,50.62036,{"lat":276,"lon":275},[279],{"name":115,"role":95,"phone":280,"phoneExt":43,"email":43},"+380971921000",{"facility":282,"status":101,"city":283,"state":284,"zip":285,"country":184,"countryCode":185,"cosmosGeoPoint":286,"geoPoint":290,"contacts":291},"Communal Noncommercial Enterprise \"Podillia Regional Oncology Center Of Vinnytsia Regional Council\" ( Site 2004)","Vinnytsia","Vinnytsia Oblast","21029",{"type":108,"coordinates":287},[288,289],28.46871,49.2322,{"lat":289,"lon":288},[292],{"name":115,"role":95,"phone":293,"phoneExt":43,"email":43},"+380432511160",{"facility":295,"status":101,"city":296,"state":297,"zip":298,"country":184,"countryCode":185,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Volyn Regional Clinical Hospital ( Site 2010)","Lutsk","Volyn Oblast","43018",{"type":108,"coordinates":300},[301,302],25.35024,50.75784,{"lat":302,"lon":301},[305],{"name":115,"role":95,"phone":306,"phoneExt":43,"email":43},"+380503782998",{"type":308,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100635565",false,"NCT07554339","A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015\u002FKANDLELIT-015)","A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.\n* Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.\n* Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.\n* Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.\n* If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n* Has a body weight ≥35 kg.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.\n* Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* Has received prior treatment (other than definitive CCRT) for NSCLC.\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 the past 2 years.\n* Has a history of, or has current, (noninfectious) pneumonitis\u002Finterstitial lung disease that required\u002Frequires steroids.\n* Has an active infection requiring systemic therapy.\n* Has a history of stem cell\u002Fsolid organ transplant.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","ALL","18 Years",{"count":318,"type":319},310,"ESTIMATED","INTERVENTIONAL",[322],"PHASE3","Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.\n\nThe goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.",[325],"Non-small Cell Lung Cancer","2026-06-25",{"date":328,"type":329},"2026-06-26","ACTUAL",{"date":331,"type":329},"2026-06-18",{"date":333,"type":319},"2037-08-17",{"name":5,"class":6},16]