编号/登记号:
NCT06875310
注册时间:
2025-03-13
研究开始时间:
2025-04-24
研究结束时间:
2032-04-30
项目类型:
clinicaltrials临床试验
本院角色:
参与单位
多中心研究:
国际多中心
参与国家:
Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;France;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Mexico;Netherlands;Poland;Portugal;Romania;Saudi Arabia;South Korea;Spain;Switzerland;Taiwan;Thailand;Turkey (Türkiye);United Kingdom;United States
招募状态:
Recruiting
研究疾病/适应症:
Carcinoma, Non-Small-Cell Lung
研究类型:
Interventional
研究单位:
[1]Mirati Therapeutics Inc.
[2]Local Institution - 0347,Birmingham 4049979,Alabama 4829764,United States,35294-3300
[3]Local Institution - 0581,Fullerton 5351247,California 5332921,United States,92835
[4]Local Institution - 0202,Long Beach 5367929,California 5332921,United States,90805
[5]Local Institution - 0643,Newport Beach 5376890,California 5332921,United States,92663
[6]Local Institution - 0666,Orange 5379513,California 5332921,United States,92868
[7]Local Institution - 0623,Santa Barbara 5392952,California 5332921,United States,93105
[8]Local Institution - 0442,Denver 5419384,Colorado 5417618,United States,80206
[9]Local Institution - 0651,Gainesville 4156404,Florida 4155751,United States,32610
[10]Local Institution - 0621,Palm Bay 4167499,Florida 4155751,United States,32901
[11]Local Institution - 0377,Tamarac 4174738,Florida 4155751,United States,33321
[12]Local Institution - 0647,Tampa 4174757,Florida 4155751,United States,33612
[13]Local Institution - 0392,Fort Eisenhower 7267471,Georgia 4197000,United States,30905
[14]Local Institution - 0031,Marietta 4207783,Georgia 4197000,United States,30060
[15]Local Institution - 0665,Arlington Heights 4883555,Illinois 4896861,United States,60005
[16]Local Institution - 0423,Munster 4924014,Indiana 4921868,United States,46321
[17]Local Institution - 0366,Edgewood 4290873,Kentucky 6254925,United States,41017
[18]Local Institution - 0566,Louisville 4299276,Kentucky 6254925,United States,40202
[19]Local Institution - 0644,Shreveport 4341513,Louisiana 4331987,United States,71103
[20]Local Institution - 0385,Columbia 4352053,Maryland 4361885,United States,21044
[21]Local Institution - 0019,Boston 4930956,Massachusetts 6254926,United States,02215
[22]Local Institution - 0437,Worcester 4956184,Massachusetts 6254926,United States,01655
[23]Local Institution - 0618,White Plains 5144336,New York 5128638,United States,10601
[24]Local Institution - 0624,Asheville 4453066,North Carolina 4482348,United States,28806
[25]Local Institution - 0672,Salisbury 4489985,North Carolina 4482348,United States,28144
[26]Local Institution - 0620,Columbus 4509177,Ohio 5165418,United States,43219
[27]Local Institution - 0657,York 4562407,Pennsylvania 6254927,United States,17403
[28]Local Institution - 0658,Greenville 4580543,South Carolina 4597040,United States,29607
[29]Local Institution - 0652,Laredo 4705349,Texas 4736286,United States,78041
[30]Local Institution - 0622,San Antonio 4726206,Texas 4736286,United States,78217
[31]Instituto Alexander Fleming,Ciudad Autónoma de Buenos Aires,Buenos Aires 3435907,Argentina,C1426ANZ
[32]IDIM - Instituto de Investigaciones Metabólicas,Ciudad de Buenos Aires,Buenos Aires 3435907,Argentina,C1012AAR
[33]Local Institution - 0584,Pilar 3429980,Buenos Aires 3435907,Argentina,1629
[34]Hospital Italiano de Buenos Aires,ABB,Buenos Aires F.D. 3433955,Argentina,C1199ABB
[35]Local Institution - 0571,Buenos Aires 3435910,Buenos Aires F.D. 3433955,Argentina,C1417DTB
[36]Clinica Adventista Belgrano,CABA,Buenos Aires F.D. 3433955,Argentina,C1430EGF
[37]Sanatorio Plaza,Rosario 3838583,Santa Fe Province 3836276,Argentina,2000
[38]Local Institution - 0126,Canberra 2172517,Australian Capital Territory 2177478,Australia,2605
[39]Tamworth Hospital,North Tamworth 10114337,New South Wales 2155400,Australia,2340
[40]Orange Hospital,Orange 2154219,New South Wales 2155400,Australia,2800
[41]Princess Alexandra Hospital,Brisbane 2174003,Queensland 2152274,Australia,4102
[42]Lyell McEwin Hospital,Elizabeth Vale 9973185,South Australia 2061327,Australia,5112
[43]Frankston Hospital,Frankston 2166144,Victoria 2145234,Australia,3199
[44]Northern Hospital,Melbourne 2158177,Victoria 2145234,Australia,3076
[45]Latrobe Regional Health,Traralgon 2146108,Victoria 2145234,Australia,3844
[46]Joondalup Health Campus,Joondalup 6695255,Western Australia 2058645,Australia,6027
[47]Medizinische Universität Graz,Graz 2778067,Styria 2764581,Austria,8036
[48]Klinikum Wels-Grieskirchen GmbH,Wels 2761524,Upper Austria 2769848,Austria,4600
[49]Kepler Universitätsklinikum,Linz 2772400,Austria,4021
[50]Medizinische Universität Wien,Vienna 2761369,Austria,1090
[51]Local Institution - 0673,Vienna 2761369,Austria,1210
[52]UZ Brussel,Brussels 2800866,Bruxelles-Capitale, Région de,Belgium,1090
[53]Cliniques universitaires Saint-Luc,Brussels 2800866,Bruxelles-Capitale, Région de,Belgium,1200
[54]Jessa Ziekenhuis,Hasselt 2796491,Limburg,Belgium,3500
[55]AZ Maria Middelares,Ghent 2797656,Oost-Vlaanderen,Belgium,9000
[56]UZ Leuven,Leuven 2792482,Vlaams-Brabant,Belgium,3000
[57]Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman,Liège 2792413,Belgium,4000
[58]Local Institution - 0242,Vitória 3444924,Espírito Santo 3463930,Brazil,29055450
[59]Local Institution - 0257,Salvador 3450554,Estado de Bahia 3471168,Brazil,40170-110
[60]Local Institution - 0244,Belo Horizonte 3470127,Minas Gerais 3457153,Brazil,30110-022
[61]Local Institution - 0235,Ijuí 3461444,Rio Grande do Sul 3451133,Brazil,98700-000
[62]Local Institution - 0233,Porto Alegre 3452925,Rio Grande do Sul 3451133,Brazil,90610-000
[63]Local Institution - 0238,Santa Cruz do Sul 3450269,Rio Grande do Sul 3451133,Brazil,96830-180
[64]Local Institution - 0243,Porto Velho 3662762,Rondônia 3924825,Brazil,76834-899
[65]Local Institution - 0237,Blumenau 3469968,Santa Catarina 3450387,Brazil,89010-340
[66]Local Institution - 0245,Itajaí 3460845,Santa Catarina 3450387,Brazil,88301-220
[67]Local Institution - 0240,Barretos 3470451,São Paulo 3448433,Brazil,14784400
[68]Local Institution - 0241,São Carlos 3449319,São Paulo 3448433,Brazil,13561-130
[69]Local Institution - 0239,São José do Rio Preto 3448639,São Paulo 3448433,Brazil,15090-000
[70]Local Institution - 0254,São Paulo 3448439,São Paulo 3448433,Brazil,01509-010
[71]Local Institution - 0236,Rio de Janeiro 3451190,Brazil,20230-130
[72]Local Institution - 0258,São Paulo 3448439,Brazil,01246-000
[73]Local Institution - 0629,Panagyurishte 728448,Pazardzhik 728379,Bulgaria,4500
[74]Local Institution - 0628,Sofia 727011,Sofia (stolitsa),Bulgaria,1632
[75]Complex Oncology Center - Ruse EOOD,Rousse 727523,Bulgaria,7002
[76]Trakia Hospital,Stara Zagora 726848,Bulgaria,6000
[77]Local Institution - 0074,Halifax 6324729,Nova Scotia 6091530,Canada,B3H 2Y9
[78]Local Institution - 0559,Montreal 6077243,Quebec 6115047,Canada,H3T 1M5
[79]Bradfordhill,Recoleta 3873635,Santiago Metropolitan 3873544,Chile,8420391
[80]FALP,Santiago 3871336,Santiago Metropolitan 3873544,Chile,7500921
[81]The First Afflilated Hospital of Bengbu Medical College,Bengbu 1816440,Anhui 1818058,China,233017
[82]Anhui Provincial Hospital,Hefei 1808722,Anhui 1818058,China,230071
[83]Beijing Cancer hospital,Beijing 1816670,Beijing Municipality 2038349,China,100142
[84]Local Institution - 0491,Beijing 1816670,Beijing Municipality 2038349,China,100730
[85]Local Institution - 0397,Beijing 1816670,Beijing Municipality 2038349,China,101149
[86]Chongqing University Cancer Hospital,Chongqing 1814906,Chongqing Municipality 1814905,China,400030
[87]Local Institution - 0362,Fuzhou Fujian,Fujian 1811017,China,350001
[88]The First Affiliated hospital of Xiamen University,Xiamen 1790645,Fujian 1811017,China,361003
[89]The First Affiliated Hospital, Sun Yat-sen University,Guangzhou 1809858,Guangdong 1809935,China,0
[90]The First Affiliated Hospital of Guangzhou Medical University,Guangzhou 1809858,Guangdong 1809935,China,510140
[91]Cancer Hospital of Shantou University Medical College,Shantou 1795940,Guangdong 1809935,China,515041
[92]Cancer Hospital Chinese Academy of Medical Sciences. Shenzhen Center,Shenzhen 1795565,Guangdong 1809935,China,0
[93]ShenZhen People''s Hospital,Shenzhen 1795565,Guangdong 1809935,China,518020
[94]Guangxi Medical University Affiliated Tumor Hospital,Nanning 1799869,Guangxi 1809867,China,530021
[95]Fourth Hospital of Hebei Medical University,Shijiazhuang 1795270,Hebei 1808773,China,050035
[96]Harbin Medical University Cancer Hospital,Harbin 2037013,Heilongjiang 2036965,China,150081
[97]Nanyang City Center Hospital,Nanyang 1799629,Henan 1808520,China,473009
[98]The First Affiliated Hospital of Xinxiang Medical University,Xinxiang 1788572,Henan 1808520,China,453100
[99]Tongji Hospital Tongji Medical,Science & Technology,Wuhan 1791247,Hubei 1806949,China,430030
[100]Local Institution - 0398,Changsha 1815577,Hunan 1806691,China,410013
[101]Local Institution - 0371,Nanjing 1799962,Jiangsu 1806260,China,210000
[102]The First Affiliated Hospital of Soochow University,Suzhou 1886760,Jiangsu 1806260,China,215006
[103]Northern Jiangsu People''s Hospital,Yangzhou 1787227,Jiangsu 1806260,China,225001
[104]The Second Affiliated Hospital of Nanchang University,Nanchang 1800163,Jiangxi 1806222,China,330006
[105]The First Hospital of Jilin University,Changchun 2038180,Jilin 2036500,China,130021
[106]The First Hospital of China Medical University,Shenyang 2034937,Liaoning 2036115,China,110001
[107]Shengjing Hospital of China Medical University,Shenyang 2034937,Liaoning 2036115,China,110004
[108]Local Institution - 0493,Shenyang 2034937,Liaoning 2036115,China,110042
[109]Shandong Cancer Hospital,Jinan 1805753,Shandong 1796328,China,250117
[110]LinYi Cancer Hospital,Linyi 1803318,Shandong 1796328,China,276001
[111]Local Institution - 0470,Shanghai 1796236,Shanghai Municipality 1796231,China,200030
[112]Local Institution - 0381,Shanghai 1796236,Shanghai Municipality 1796231,China,200032
[113]Shanxi Cancer Hospital,Taiyuan 1793511,Shanxi 1795912,China,030000
[114]Sichuan Cancer hospital,Chengdu 1815286,Sichuan 1794299,China,610041
[115]West China Hospital, Sichuan University,Chengdu 1815286,Sichuan 1794299,China,610041
[116]Tianjin Medical University General Hospital,Tianjin 1792947,Tianjin Municipality 1792943,China,300052
[117]Local Institution - 0462,Hangzhou 1808926,Zhejiang 1784764,China,310003
[118]Sir Run Run Shaw Hospital of Zhejiang University School of Medicine,Hangzhou 1808926,Zhejiang 1784764,China,310016
[119]Zhejiang Cancer Hospital,Hangzhou 1808926,Zhejiang 1784764,China,310022
[120]Taizhou Hospital of Zhejiang Province,Linhai 1803422,Zhejiang 1784764,China,317000
[121]Shanghai East Hospital,Shanghai 1796236,China,200120
[122]Local Institution - 0580,Medellín 3674962,Antioquia 3689815,Colombia,050030
[123]Local Institution - 0171,Rionegro 3670730,Antioquia 3689815,Colombia,054040
[124]Local Institution - 0191,Puerto Colombia 3671497,Atlántico 3689436,Colombia,81001
[125]Local Institution - 0189,Bogotá 3688689,Bogota D.C. 3688685,Colombia,110131
[126]Local Institution - 0253,Valledupar 3666304,Cesar Department 3686880,Colombia,200001
[127]Local Institution - 0167,Montería 3674453,COR,Colombia,230002
[128]Local Institution - 0671,Bogota,Cundinamarca 3685413,Colombia,111151
[129]Local Institution - 0170,Floridablanca 3682385,Santander Department 3668578,Colombia,681004
[130]Local Institution - 0173,Santiago de Cali 3687925,Valle del Cauca Department 3666313,Colombia,760032
[131]Local Institution - 0619,Dubrovnik 3201047,Dubrovnik-Neretva County 3337513,Croatia,20000
关键词:
Immunotherapy
KRAS
KRAS G12C
Targeted therapy
研究目的:
This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation