A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
研究单位:[1]AbbVie[2]University of Alabama at Birmingham - Main /ID# 247074,Birmingham,Alabama,United States,35233[3]Ironwood Cancer & Res Ctr /ID# 262446,Chandler,Arizona,United States,85224-5665[4]Mayo Clinic Arizona /ID# 255858,Phoenix,Arizona,United States,85054-4504[5]Yuma Regional Medical Center /ID# 253625,Yuma,Arizona,United States,85364[6]City of Hope /ID# 243157,Duarte,California,United States,91010[7]City Of Hope - Seacliff /ID# 263143,Huntington Beach,California,United States,92648[8]City of Hope Orange County Lennar Foundation Cancer Center /ID# 263144,Irvine,California,United States,92618[9]City of Hope - Antelope Valley /ID# 263138,Lancaster,California,United States,93534[10]The Oncology Institute of Hope and Innovation - DTLA /ID# 239774,Los Angeles,California,United States,90015-3070[11]University of California, Los Angeles /ID# 253954,Los Angeles,California,United States,90095[12]Eisenhower Medical Center /ID# 233189,Rancho Mirage,California,United States,92270-3221[13]Mayo Clinic /ID# 254688,Jacksonville,Florida,United States,32224[14]Ocala Oncology Florida Cancer Affiliates - Main /ID# 234228,Ocala,Florida,United States,34474-4445[15]BRCR Medical Center Inc /ID# 262344,Tamarac,Florida,United States,33321-2919[16]Memorial University Medical Center /ID# 264081,Savannah,Georgia,United States,31404[17]Kaiser Permanente Moanalua Medical Center /ID# 238363,Honolulu,Hawaii,United States,96819-1469[18]Edward-Elmhurst Cancer Center /ID# 238552,Elmhurst,Illinois,United States,60126[19]Springfield Clinic /ID# 262290,Springfield,Illinois,United States,62702-3749[20]Goshen Center for Cancer Care /ID# 257734,Goshen,Indiana,United States,46526[21]Investigative Clinical Research of Indiana - Indianapolis /ID# 260468,Indianapolis,Indiana,United States,46260[22]Baptist Health Lexington /ID# 252769,Lexington,Kentucky,United States,40503[23]Dana-Farber Cancer Institute /ID# 247132,Boston,Massachusetts,United States,02215[24]Trinity Health St. Joseph Mercy Ann Arbor /ID# 232190,Ypsilanti,Michigan,United States,48197-1051[25]Mayo Clinic - Rochester /ID# 252052,Rochester,Minnesota,United States,55905-0001[26]Hattiesburg Clinic /ID# 248033,Hattiesburg,Mississippi,United States,39401[27]St. Luke's Hospital - Chesterfield /ID# 251688,Chesterfield,Missouri,United States,63017[28]St. Luke's Hosp. of Kansas City /ID# 259940,Kansas City,Missouri,United States,64111[29]Alliance for Multispecialty Research (AMR) - Kansas City /ID# 247567,Kansas City,Missouri,United States,64114-4859[30]Saint Louis University Cancer Center /ID# 260722,Saint Louis,Missouri,United States,63110-2539[31]Hulston Cancer Center /ID# 232226,Springfield,Missouri,United States,65807-5287[32]Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 253147,Billings,Montana,United States,59102[33]Nebraska Hematology Oncology /ID# 257710,Lincoln,Nebraska,United States,68506[34]Renown Medical Group - Oncology/Hematology /ID# 247942,Reno,Nevada,United States,89502-1464[35]Astera Cancer Care /ID# 257753,East Brunswick,New Jersey,United States,08816-4096[36]San Juan Oncology Associates /ID# 244387,Farmington,New Mexico,United States,87401[37]Maimonides Medical Center /ID# 240783,Brooklyn,New York,United States,11219[38]Northwell Health - Monter Cancer Center /ID# 247081,Lake Success,New York,United States,11042[39]AdventHealth Hendersonville /ID# 265349,Hendersonville,North Carolina,United States,28792[40]FirstHealth of the Carolinas- Speciality Center /ID# 241279,Pinehurst,North Carolina,United States,28374[41]Genesis Cancer Care Center /ID# 239190,Zanesville,Ohio,United States,43701-1406[42]Cancer Care Associates Of York /ID# 266143,York,Pennsylvania,United States,17403[43]Medical University of South Carolina /ID# 251383,Charleston,South Carolina,United States,29425[44]Avera Cancer Institute - Aberdeen /ID# 257759,Aberdeen,South Dakota,United States,57401[45]Avera Cancer Institute /ID# 239635,Sioux Falls,South Dakota,United States,57105[46]Memphis VA Medical Center /ID# 263250,Memphis,Tennessee,United States,38104[47]Dell Seton Medical Center /ID# 247016,Austin,Texas,United States,78701[48]Community Cancer Trials of Utah - South Ogden /ID# 262829,Ogden,Utah,United States,84405-7194[49]Valley Medical Center /ID# 253950,Renton,Washington,United States,98055-5738[50]Medical Oncology Associates /ID# 247003,Spokane,Washington,United States,99208[51]Centro Médico Austral /ID# 239860,Ciudad Autonoma Buenos Aires,Ciudad Autonoma De Buenos Aires,Argentina,1019[52]Cenit /Id# 239880,Ciudad Autonoma de Buenos Aire,Ciudad Autonoma De Buenos Aires,Argentina,1125[53]Hospital Britanico de Buenos Aires /ID# 231495,Ciudad Autonoma de Buenos Aire,Ciudad Autonoma De Buenos Aires,Argentina,1280[54]Centro de Investigaciones Clinicas Clinica Viedma S.A. /ID# 232339,Viedma,Rio Negro,Argentina,8500[55]Barwon Health /ID# 241920,Geelong,Victoria,Australia,3220[56]Austin Health /ID# 247507,Heidelberg,Victoria,Australia,3084[57]Ordensklinikum Linz GmbH Elisabethinen /ID# 240967,Linz,Oberoesterreich,Austria,4010[58]Klinikum Wels-Grieskirchen GmbH /ID# 249000,Wels,Oberoesterreich,Austria,4600[59]Landeskrankenhaus Feldkirch /ID# 250333,Feldkirch,Vorarlberg,Austria,6800[60]Medizinische Universitaet Wien /ID# 230615,Vienna,Wien,Austria,1090[61]Klinik Penzing /ID# 230700,Vienna,Wien,Austria,1140[62]Klinik Floridsdorf /ID# 230608,Vienna,Wien,Austria,1210[63]Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 232467,Salzburg,Austria,5020[64]Algemeen Ziekenhuis klina /ID# 239853,Brasschaat,Antwerpen,Belgium,2930[65]Universitair Ziekenhuis Antwerpen /ID# 239971,Edegem,Antwerpen,Belgium,2650[66]Grand Hôpital de Charleroi - Les Viviers /ID# 234178,Charleroi,Hainaut,Belgium,6010[67]Hospital La Louviere Site Jolimont - Helora /ID# 246771,La Louvière,Hainaut,Belgium,7100[68]CHU de Liège /ID# 246772,Liège,Liege,Belgium,4000[69]Jessa Ziekenhuis /ID# 246766,Hasselt,Limburg,Belgium,3500[70]Institut Jules Bordet /ID# 246770,Anderlecht,Belgium,1070[71]AZ Maria Middelares /ID# 246768,Gent,Belgium,9000[72]UCL Namur University Hospital, Site Sainte-Elisabeth /ID# 246769,Namur,Belgium,5000[73]Ensino e Terapia de Inovacao - Clinica AMO /ID# 231604,Salvador,Bahia,Brazil,41950-610[74]Irmandade da Santa Casa de Misericordia de Porto Alegre /ID# 233249,Porto Alegre,Rio Grande Do Sul,Brazil,90020-090[75]Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 233247,Barretos,Sao Paulo,Brazil,14784-400[76]Instituto Nacional de Cancer (INCA) /ID# 231509,Rio de Janeiro,Brazil,20231-050[77]Instituto D'or de Pesquisa e Ensino /ID# 233245,Rio de Janeiro,Brazil,22281-100[78]Instituto de Ensino e Pesquisas Sao Lucas /ID# 247417,Sao Paulo,Brazil,01236-030[79]Casa de Saúde Santa Marcelina /ID# 231605,Sao Paulo,Brazil,08270-070[80]University Multiprofile Hospital for Active Treatment Sofiamed /ID# 234108,Sofiya,Sofia,Bulgaria,1797[81]Complex Oncology Center - Burgas /ID# 240532,Burgas,Bulgaria,8000[82]Complex Cancer Center Plovdiv /ID# 234106,Plovdiv,Bulgaria,4004[83]UMHAT Sveta Marina /ID# 234112,Varna,Bulgaria,9010[84]William Osler Health System /ID# 254420,Brampton,Ontario,Canada,L6R 3J7[85]CISSS de la Monteregie /ID# 239081,Greenfield Park,Quebec,Canada,J4V 2H1[86]Clinica Universidad Catolica del Maule /ID# 231294,Talca,Maule,Chile,3461341[87]Icegclinic /Id# 231212,La Florida,Region Metropolitana De Santiago,Chile,8241479[88]Sociedad Prosalud Montes y Orlandi /ID# 231154,Providencia,Region Metropolitana De Santiago,Chile,7500713[89]Fundacion Arturo Lopez Perez /ID# 231151,Providencia,Region Metropolitana De Santiago,Chile,7500921[90]Sociedad Oncovida /ID# 231152,Providencia,Region Metropolitana De Santiago,Chile,7510032[91]Anhui Medical University - Anhui Chest Hospital /ID# 231899,Hefei,Anhui,China,230032[92]Beijing Cancer Hospital /ID# 231923,Beijing,Beijing,China,100142[93]Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 233175,Beijing,Beijing,China,100730[94]Beijing Chest Hospital, Capital Medical University /ID# 232202,Beijing,Beijing,China,101149[95]The First Affiliated Hospital of Chongqing Medical University /ID# 251592,Chongqing,Chongqing,China,400016[96]Fujian Provincial Cancer Hospital /ID# 243134,Fuzhou,Fujian,China,350014[97]The First Affiliated Hospital of Xiamen University /ID# 242381,Xiamen,Fujian,China,361003[98]The First Affiliated Hospital of Guangzhou Medical University /ID# 238591,Guangzhou,Guangdong,China,510163[99]Cancer Hospital of Shantou University Medical College /ID# 242182,Shantou,Guangdong,China,515041[100]Affiliated Hospital of Guangdong Medical College /ID# 233317,Zhanjiang,Guangdong,China,524004[101]Affiliated Cancer Hospital of Guangxi Medical University /ID# 231855,Nanning,Guangxi,China,530021[102]People's Hospital of Guizhou Province /ID# 243614,Guiyang,Guizhou,China,550002[103]Affiliated Hospital of Hebei University /ID# 239586,Baoding,Hebei,China,071000
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to determine if telisotuzumab vedotin works better than docetaxel and to assess how safe telisotuzumab vedotin is in adult participants with NSCLC who have previously been treated. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of Teliso-V or Docetax at an 1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin or IV infusion of docetaxel. Approximately 698 adult participants with c-Met overexpressing NSCLC will be enrolled in the study in approximately 300 sites worldwide. Participants will receive IV telisotuzumab vedotin every 2 weeks or docetaxel every 3 weeks until meeting study drug discontinuation criteria. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.