[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479659":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":84,"centralContacts":88,"locations":93,"responsibleParty":395,"collaborators":398,"id":404,"slug":10,"hasResults":405,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":405,"sex":411,"minAge":412,"maxAge":10,"enrollmentInfo":413,"targetDuration":10,"studyType":416,"phases":10,"briefSummary":417,"conditions":418,"keywords":10,"overallStatus":96,"whyStopped":10,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},{"fullName":5,"class":6},"Seoul National University Bundang Hospital","OTHER",[8,22,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Tier 1. Therapeutic use of investigational products (KOSMOS-II drugs)",null,"If there are no drugs available under current regulation or patients are not feasible to any clinical trials, and If tumors have actionable genetic alterations and approved drug in any indications but tumor type is not indicative, the MTB may recommend one of KOSMOS-II drugs, therapeutic use of investigational products.",[13,14,15,16,17,18,19,20,21],"Drug: Alectinib","Drug: Atezolizumab","Drug: Erlotinib","Drug: Trastuzumab + Pertuzumab","Drug: Trastuzumab emtansine","Drug: Vemurafenib","Drug: Bevacizumab + Erlotinib","Drug: Entrectinib","Drug: Pralsetinib",{"label":23,"type":10,"description":24,"interventionNames":10},"Tier 2: Alternative treatments","If there are no KOSMOS-II drugs (Tier 1) or clinical trials (Tier 3) appropriate for patients, the MTB may recommend alternative treatment options (e.g., conventional therapy, radiotherapy, or supportive care).",{"label":26,"type":10,"description":27,"interventionNames":10},"Tier 3: Clinical trial","If patient is eligible for clinical trials matched for actionable genomic alterations found in NGS testing, the MTB will recommend enrollment to clinical trials.",[29,36,42,48,54,60,66,72,78],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Alectinib","ALK fusion or mutations, Mutations or amplification in any of the following: RET",[9],[35],"Alecensa",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Atezolizumab","MSI high status by any method Or Any mutation in any of these genes:\n\nMLH1 or MSH2 or MSH6 or PMS2 or EPCAM Or Any of the following mutations in POLE: R150X, P286R, P286H, S297F, Y298fs, F367S, V411, L424V, P436R, S459F, R665W, L698fs, R762W, R1519C, R1826W, D316H, D316G, R409W, L474P Or Any of the following mutations in POLD1: P112fs, A930fs, S478N Or Any mutation in the following: POLE not listed above, POLD1 not listed above, POLD2, POLD3, POLD4, POLQ or PRKDC Or Any loss of function mutations in BRCA1, BRCA2, ATM, MSH3, PMS1, MLH3, EXO1, RFC1, RFC2, RFC3, RFC4, RFC5, PCNA, RPA1, PRA2, PRA3, PRA4, or SSBP1 High tumor mutational burden decided by KOSMOS-II MTB (TMB ≥20\u002FMb in local NGS or if 10-20\u002FMb, confirmed by central NGS te sting)",[9],[41],"Tecentriq",{"type":30,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Erlotinib","EGFR Exon 19 deletions in the region E746\\_E759;\n\nAny of the following EGFR mutations:\n\nE709A, E709G, E709K, E884K, G719A, G719C, G719S, L858R, L861Q, L833V, S768I",[9],[47],"Tarceva",{"type":30,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"Trastuzumab + Pertuzumab","ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:\n\nG309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y, L755S, p.L75 5\\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 amplification or approved by the KOSMOS Molecular Tumor Board",[9],[53],"Herceptin + Perjeta",{"type":30,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Trastuzumab emtansine","ERBB2 amplification, or over-expression; or presence of any of the following ERBB2 mutations:\n\nG309A, G309E, S310F, S310Y, R678Q, I655V, D769H, D769Y,L755S, p.L75 5\\_T759del, I767M, V777L, E321G, R896C; P780ins; delL755-T759 ERBB2 oncogenic mutations; G152V, X215\\_splice, D277Y, G292C, N302K, V308M, G309A, S310F, S310Y, S244C, L651V, V659E, G660D, R678Q, V697L, G727A, T733I, L755A, L755P, L755S, D769H, D769Y, A775\\_G776insSVMA, A775\\_G776insYVMA (i.e.,Y772\\_A775dup,M774\\_A775insAYVME 770delinsEAYVM), G776\\_V777 \\> AVCV, G776\\_V777 \\> AVGCV, G776\\_V777 \\> VCV, G776\\_V777insVC, G776C, G776delinsLCT, G776L, G776dleinsVC, G776L777\\_G778insC, V777L, V777M, G778\\_Y779insGSP, P780\\_Y781insGSP (i.e.,G778\\_P780dup), L786V, N813D, R840W, V842I, T862A, R896G, E1021Q or approved by the KOSMOS Molecular Tumor Board",[9],[59],"Kadcyla",{"type":30,"name":61,"description":62,"armGroupLabels":63,"otherNames":64},"Vemurafenib","BRAF\\_V600E\u002FD\u002FK\u002FR mutations",[9],[65],"Zelboraf",{"type":30,"name":67,"description":68,"armGroupLabels":69,"otherNames":70},"Bevacizumab + Erlotinib","FH inactivating mutations or approved by the KOSMOS Molecular Tumor Board",[9],[71],"Avastin + Tarceva",{"type":30,"name":73,"description":74,"armGroupLabels":75,"otherNames":76},"Entrectinib","ROS1 gene fusion using either a fluo rescence in situ hybridization (FISH) or next-generation sequencing (NGS) or approved by the KOSMOS Molecular Tumor Board",[9],[77],"Rozlytrek",{"type":30,"name":79,"description":80,"armGroupLabels":81,"otherNames":82},"Pralsetinib","RET fusion or mutations; CCDC6 RET, RET V804L, RET V804M, RET M918T, KIF5B-RET, RET C634W or approved by the KOSMOS Molecular Tumor Board",[9],[83],"Gavreto",[85],{"name":86,"affiliation":5,"role":87},"JEEHYUN KIM","STUDY_DIRECTOR",[89],{"name":86,"role":90,"phone":91,"phoneExt":10,"email":92},"CONTACT","+82)070-4193-8602","kosmos2@kcsg.org",[94,108,119,130,138,146,157,168,179,190,198,209,220,231,242,249,260,268,276,284,290,298,306,314,322,330,338,346,357,365,376,384],{"facility":95,"status":96,"city":97,"state":10,"zip":10,"country":98,"cosmosGeoPoint":99,"geoPoint":104,"contacts":105},"Soonchunhyang University Hospital Bucheon","RECRUITING","Bucheon-si","South Korea",{"type":100,"coordinates":101},"Point",[102,103],126.78306,37.49889,{"lat":103,"lon":102},[106],{"name":107,"role":90,"phone":10,"phoneExt":10,"email":10},"Jin-A Yun",{"facility":109,"status":96,"city":110,"state":10,"zip":10,"country":98,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Chungbuk National University Hospital","Chungju",{"type":100,"coordinates":112},[113,114],127.9287,36.97666,{"lat":114,"lon":113},[117],{"name":118,"role":90,"phone":10,"phoneExt":10,"email":10},"Yae-Won Yang",{"facility":120,"status":96,"city":121,"state":10,"zip":10,"country":98,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"Keimyung University Dongsan Hospital","Daegu",{"type":100,"coordinates":123},[124,125],128.59111,35.87028,{"lat":125,"lon":124},[128],{"name":129,"role":90,"phone":10,"phoneExt":10,"email":10},"Keon-Uk Park",{"facility":131,"status":96,"city":121,"state":10,"zip":10,"country":98,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"Kyungpook National University Chilgok Hospital",{"type":100,"coordinates":133},[124,125],{"lat":125,"lon":124},[136],{"name":137,"role":90,"phone":10,"phoneExt":10,"email":10},"In-Hee Lee",{"facility":139,"status":96,"city":121,"state":10,"zip":10,"country":98,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Yeungnam University Medical Center",{"type":100,"coordinates":141},[124,125],{"lat":125,"lon":124},[144],{"name":145,"role":90,"phone":10,"phoneExt":10,"email":10},"Ji-Yoon Jeong",{"facility":147,"status":96,"city":148,"state":10,"zip":10,"country":98,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Chungnam National University Hospital","Daejeon",{"type":100,"coordinates":150},[151,152],127.38493,36.34913,{"lat":152,"lon":151},[155],{"name":156,"role":90,"phone":10,"phoneExt":10,"email":10},"So-ra Kang",{"facility":158,"status":96,"city":159,"state":10,"zip":10,"country":98,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"National Cancer Center","Goyang",{"type":100,"coordinates":161},[162,163],127.19731,36.21689,{"lat":163,"lon":162},[166],{"name":167,"role":90,"phone":10,"phoneExt":10,"email":10},"Wonyoung Choi",{"facility":169,"status":96,"city":170,"state":10,"zip":10,"country":98,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Chonnam National University Hwasun Hospital","Hwasun",{"type":100,"coordinates":172},[173,174],126.98746,35.06125,{"lat":174,"lon":173},[177],{"name":178,"role":90,"phone":10,"phoneExt":10,"email":10},"Sang Hee Cho",{"facility":180,"status":96,"city":181,"state":10,"zip":10,"country":98,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Gachon University Gil Medical Center","Incheon",{"type":100,"coordinates":183},[184,185],126.70515,37.45646,{"lat":185,"lon":184},[188],{"name":189,"role":90,"phone":10,"phoneExt":10,"email":10},"YoungSaing Kim",{"facility":191,"status":96,"city":181,"state":10,"zip":10,"country":98,"cosmosGeoPoint":192,"geoPoint":194,"contacts":195},"The Catholic University of Korea, Incheon St. Mary's Hospital",{"type":100,"coordinates":193},[184,185],{"lat":185,"lon":184},[196],{"name":197,"role":90,"phone":10,"phoneExt":10,"email":10},"JaeHo Byun",{"facility":199,"status":96,"city":200,"state":10,"zip":10,"country":98,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Jeonbuk National University Hospital","Jeonju",{"type":100,"coordinates":202},[203,204],127.14889,35.82194,{"lat":204,"lon":203},[207],{"name":208,"role":90,"phone":10,"phoneExt":10,"email":10},"So-Yeon Jeon",{"facility":210,"status":96,"city":211,"state":10,"zip":10,"country":98,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Gyeongsang National University Hospital","Jinju",{"type":100,"coordinates":213},[214,215],128.08472,35.19278,{"lat":215,"lon":214},[218],{"name":219,"role":90,"phone":10,"phoneExt":10,"email":10},"Gyeong-Won Lee",{"facility":221,"status":96,"city":222,"state":10,"zip":10,"country":98,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Dong-A University Hospital","Pusan",{"type":100,"coordinates":224},[225,226],128.02524,35.70128,{"lat":226,"lon":225},[229],{"name":230,"role":90,"phone":10,"phoneExt":10,"email":10},"Seok-Jae Huh",{"facility":232,"status":96,"city":233,"state":10,"zip":10,"country":98,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Cha University Bundang Medical Center","Seongnam",{"type":100,"coordinates":235},[236,237],127.7548,36.4052,{"lat":237,"lon":236},[240],{"name":241,"role":90,"phone":10,"phoneExt":10,"email":10},"Beo-Deul Kang",{"facility":5,"status":96,"city":233,"state":10,"zip":10,"country":98,"cosmosGeoPoint":243,"geoPoint":245,"contacts":246},{"type":100,"coordinates":244},[236,237],{"lat":237,"lon":236},[247],{"name":248,"role":90,"phone":10,"phoneExt":10,"email":10},"Jee Hyun Kim",{"facility":250,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":252,"geoPoint":256,"contacts":257},"Asan Medical Center","Seoul",{"type":100,"coordinates":253},[254,255],126.9784,37.566,{"lat":255,"lon":254},[258],{"name":259,"role":90,"phone":10,"phoneExt":10,"email":10},"Min-Hee Ryu",{"facility":261,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":262,"geoPoint":264,"contacts":265},"Chung-ang University Hospital",{"type":100,"coordinates":263},[254,255],{"lat":255,"lon":254},[266],{"name":267,"role":90,"phone":10,"phoneExt":10,"email":10},"Yong-Ho Noh",{"facility":269,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":270,"geoPoint":272,"contacts":273},"Ewha womans university Mokdong Hospital",{"type":100,"coordinates":271},[254,255],{"lat":255,"lon":254},[274],{"name":275,"role":90,"phone":10,"phoneExt":10,"email":10},"Kyung-Eun Lee",{"facility":277,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":278,"geoPoint":280,"contacts":281},"Gangbuk Samsung Hospital",{"type":100,"coordinates":279},[254,255],{"lat":255,"lon":254},[282],{"name":283,"role":90,"phone":10,"phoneExt":10,"email":10},"Dong-Hoe Koo",{"facility":285,"status":286,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":287,"geoPoint":289,"contacts":10},"Hanyang University Hospital","TERMINATED",{"type":100,"coordinates":288},[254,255],{"lat":255,"lon":254},{"facility":291,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"Korea University Anam Hospital",{"type":100,"coordinates":293},[254,255],{"lat":255,"lon":254},[296],{"name":297,"role":90,"phone":10,"phoneExt":10,"email":10},"Jiwon Lee",{"facility":299,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":300,"geoPoint":302,"contacts":303},"Korea University Guro Hospital",{"type":100,"coordinates":301},[254,255],{"lat":255,"lon":254},[304],{"name":305,"role":90,"phone":10,"phoneExt":10,"email":10},"Eunju Kang",{"facility":307,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":308,"geoPoint":310,"contacts":311},"Samsung Medical Center",{"type":100,"coordinates":309},[254,255],{"lat":255,"lon":254},[312],{"name":313,"role":90,"phone":10,"phoneExt":10,"email":10},"Jin-Young Kim",{"facility":315,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":316,"geoPoint":318,"contacts":319},"Seoul National University Hospital",{"type":100,"coordinates":317},[254,255],{"lat":255,"lon":254},[320],{"name":321,"role":90,"phone":10,"phoneExt":10,"email":10},"Tae-Yong Kim",{"facility":323,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":324,"geoPoint":326,"contacts":327},"The Catholic University of Korea, Seoul ST. Mary's Hospital",{"type":100,"coordinates":325},[254,255],{"lat":255,"lon":254},[328],{"name":329,"role":90,"phone":10,"phoneExt":10,"email":10},"Se-Jun Park",{"facility":331,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":332,"geoPoint":334,"contacts":335},"The Catholic University of Korea, Yeouido St. Mary's Hospital",{"type":100,"coordinates":333},[254,255],{"lat":255,"lon":254},[336],{"name":337,"role":90,"phone":10,"phoneExt":10,"email":10},"In-Sook Woo",{"facility":339,"status":96,"city":251,"state":10,"zip":10,"country":98,"cosmosGeoPoint":340,"geoPoint":342,"contacts":343},"Yonsei Cancer Hospital",{"type":100,"coordinates":341},[254,255],{"lat":255,"lon":254},[344],{"name":345,"role":90,"phone":10,"phoneExt":10,"email":10},"Min-Kyu Jung",{"facility":347,"status":96,"city":348,"state":10,"zip":10,"country":98,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Ajou University Hospital","Suwon",{"type":100,"coordinates":350},[351,352],127.00889,37.29111,{"lat":352,"lon":351},[355],{"name":356,"role":90,"phone":10,"phoneExt":10,"email":10},"Mi-Sun Ahn",{"facility":358,"status":96,"city":348,"state":10,"zip":10,"country":98,"cosmosGeoPoint":359,"geoPoint":361,"contacts":362},"The Catholic University of Korea, ST. Vincent's Hospital",{"type":100,"coordinates":360},[351,352],{"lat":352,"lon":351},[363],{"name":364,"role":90,"phone":10,"phoneExt":10,"email":10},"Ho-Jung An",{"facility":366,"status":96,"city":367,"state":10,"zip":10,"country":98,"cosmosGeoPoint":368,"geoPoint":372,"contacts":373},"Ulsan University Hospital","Ulsan",{"type":100,"coordinates":369},[370,371],129.31667,35.53722,{"lat":371,"lon":370},[374],{"name":375,"role":90,"phone":10,"phoneExt":10,"email":10},"Hyeon-Su Im",{"facility":377,"status":286,"city":378,"state":10,"zip":10,"country":98,"cosmosGeoPoint":379,"geoPoint":383,"contacts":10},"Wonju Severance Christian Hospital","Wŏnju",{"type":100,"coordinates":380},[381,382],127.94528,37.35139,{"lat":382,"lon":381},{"facility":385,"status":96,"city":386,"state":10,"zip":10,"country":98,"cosmosGeoPoint":387,"geoPoint":391,"contacts":392},"Pusan National University Yangsan Hospital","Yangsan",{"type":100,"coordinates":388},[389,390],129.03358,35.34199,{"lat":390,"lon":389},[393],{"name":394,"role":90,"phone":10,"phoneExt":10,"email":10},"Jung-Hoon Kim",{"type":396,"investigatorFullName":248,"investigatorTitle":397,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Professor",[399,401],{"name":400,"class":6},"Korean Cancer Study Group",{"name":402,"class":403},"Roche Pharma AG","INDUSTRY","100479659",false,"NCT05525858","KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOrean Precision Medicine Networking Group Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II","KOSMOSII","Inclusion Criteria:\n\n* 19 years of age or older\n* Histologically proven locally advanced or metastatic solid tumors\\*\\*\\* who showed disease progression on standard first line anti-cancer treatment and\u002For has no standard treatment option\n\n  \\*\\*\\* very rare diseases without standard treatment option which form solid mass, such as Erdheim Chester disease can be enrolled after KOSMOS MTB approval\n* A genomic test results must be available in a MFDS-accredited for laboratories offering service, or in part of clinical trial\u002Fstudy or other commercial labs approved and certified by regulatory bodies compatible with MFDS, such as CLIA. A genomic test can be conducted with tumor tissue as well as plasma circulating tumor DNA.\n\n  1. Results from genomic profiling tests performed after diagnosis with metastatic\u002Fadvanced disease to registration are acceptable. NGS results performed within three years prior to registration are preferred. Those patients with NGS results from primary tumor or more than 3 years prior to enrollment can be registered and whether NGS data is acceptable will be subject to MTB decision.\n  2. NGS panels should be i. Tested in a lab that is accredited by one or more quality assurance program (e.g., Korean Institute of Genomic Testing Evaluation, The Korean Society of Pathologists, Korean Society for Laboratory Medicine, Korea Laboratory Accreditation Scheme, etc.) ii. Patients who have insufficient genomic information from their NGS results (e.g., lack of variant calling format file or uninterpretable reports) or who are candidates of immunotherapy will submit their tissue and\u002For blood, for central NGS testing and exploratory biomarker analysis.\n* Ability to understand and the willingness to sign a written informed consent document\n* Life expectancy of at least 12 weeks\n* Adequate recovery from most recent systemic or local treatment for cancer.\n\nExclusion Criteria:\n\n* Patients receiving any anti-cancer treatment (local treatment, chemotherapy, immunotherapy, targeted therapy) within 2 weeks prior to the start of study treatment\n* Any clinical condition, according to the opinion of site physicians, which makes molecular profiling guided therapy not at the best interest of the participating patient.\n* Patients who have ongoing toxicities of ≥ CTCAE 2, other than peripheral neuropathy, related to previous anti-cancer treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE 3 will be excluded. Laboratory abnormalities ≥ CTCAE 2 considered as not clinically significant by the study physician will be allowed.\n* Pregnant or breastfeeding, or intending to become pregnant during the study","ALL","19 Years",{"count":414,"type":415},1000,"ESTIMATED","OBSERVATIONAL","A national, prospective, multi-center, open-label, multi-cohort study comprised of a framework to screen patients for actionable targets and evaluation of molecular profiling guided therapy recommended by MTB based on genomic alterations using targeted and\u002For immunotherapies outside of the approved indications via local clinical practice (Tier 1 \\& 2) and clinical trials (Tier 3)",[419,420,421],"Solid Tumor","Advanced Solid Tumor","Metastatic Cancer","2026-06-17",{"date":424,"type":425},"2026-06-22","ACTUAL",{"date":427,"type":425},"2022-09-28",{"date":429,"type":415},"2027-03",{"name":5,"class":6},32]