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PRO-CTCAE includes 124 items representing 78 symptomatic toxicities drawn from the Common Terminology Criteria for Adverse Events (CTCAE). PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence\u002Fabsence. All questions employ a 7-day recall period and are scored from 0 to 4 (or 0\u002F1 for absent\u002Fpresent).","Cycle 1: Day 1, Day 8, Cycle 2 D1 and D1 of Every Even Cycle Thereafter, Through 3 Years",{"measure":48,"description":49,"timeFrame":46},"Change in GP5 item of the Functional Assessment of Cancer Therapy-General (FACT-G)","The GP5 item (\"I am bothered by side effects of treatment\") of FACT-G is used to assess overall treatment tolerability in patients by assessing the overall side effect impact on participants.",{"measure":51,"description":52,"timeFrame":12},"Duration of Response (DoR) by BICR","DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.",{"measure":54,"description":55,"timeFrame":12},"Progression-Free Survival (PFS) by BICR","PFS will be defined as the time from randomization to the first occurrence of radiographic 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270969","Athens","Georgia","30607",{"type":109,"coordinates":217},[218,219],-83.37794,33.96095,{"lat":219,"lon":218},{"facility":222,"status":102,"city":223,"state":214,"zip":224,"country":106,"countryCode":107,"cosmosGeoPoint":225,"geoPoint":229,"contacts":59},"Northwest Georgia Oncology Centers \u002FID# 275374","Marietta","30060",{"type":109,"coordinates":226},[227,228],-84.54993,33.9526,{"lat":228,"lon":227},{"facility":231,"status":232,"city":233,"state":214,"zip":234,"country":106,"countryCode":107,"cosmosGeoPoint":235,"geoPoint":239,"contacts":59},"Memorial University Medical Center \u002FID# 272467","COMPLETED","Savannah","31404",{"type":109,"coordinates":236},[237,238],-81.09983,32.08354,{"lat":238,"lon":237},{"facility":241,"status":102,"city":242,"state":243,"zip":244,"country":106,"countryCode":107,"cosmosGeoPoint":245,"geoPoint":249,"contacts":59},"Kaiser Permanente Moanalua Medical Center \u002FID# 272916","Honolulu","Hawaii","96819",{"type":109,"coordinates":246},[247,248],-157.85833,21.30694,{"lat":248,"lon":247},{"facility":251,"status":102,"city":252,"state":253,"zip":254,"country":106,"countryCode":107,"cosmosGeoPoint":255,"geoPoint":259,"contacts":59},"University of Illinois Hospital and Health Sciences System \u002FID# 275345","Chicago","Illinois","60607",{"type":109,"coordinates":256},[257,258],-87.65005,41.85003,{"lat":258,"lon":257},{"facility":261,"status":102,"city":262,"state":253,"zip":263,"country":106,"countryCode":107,"cosmosGeoPoint":264,"geoPoint":268,"contacts":59},"Illinois Cancer Specialists \u002FID# 274678","Niles","60714",{"type":109,"coordinates":265},[266,267],-87.80284,42.01892,{"lat":267,"lon":266},{"facility":270,"status":102,"city":271,"state":253,"zip":272,"country":106,"countryCode":107,"cosmosGeoPoint":273,"geoPoint":277,"contacts":59},"Springfield Clinic - First \u002FID# 272576","Springfield","62702",{"type":109,"coordinates":274},[275,276],-89.64371,39.80172,{"lat":276,"lon":275},{"facility":279,"status":102,"city":280,"state":281,"zip":282,"country":106,"countryCode":107,"cosmosGeoPoint":283,"geoPoint":287,"contacts":59},"Nebraska Hematology-Oncology \u002FID# 272970","Lincoln","Nebraska","68506",{"type":109,"coordinates":284},[285,286],-96.66696,40.8,{"lat":286,"lon":285},{"facility":289,"status":102,"city":290,"state":281,"zip":291,"country":106,"countryCode":107,"cosmosGeoPoint":292,"geoPoint":296,"contacts":59},"Nebraska Cancer Specialists - Omaha - Wright Street \u002FID# 271527","Omaha","68130",{"type":109,"coordinates":293},[294,295],-95.94043,41.25626,{"lat":295,"lon":294},{"facility":298,"status":102,"city":299,"state":300,"zip":301,"country":106,"countryCode":107,"cosmosGeoPoint":302,"geoPoint":306,"contacts":59},"Renown Regional Medical Center \u002FID# 273535","Reno","Nevada","89502",{"type":109,"coordinates":303},[304,305],-119.8138,39.52963,{"lat":305,"lon":304},{"facility":308,"status":102,"city":309,"state":310,"zip":311,"country":106,"countryCode":107,"cosmosGeoPoint":312,"geoPoint":316,"contacts":59},"Astera Cancer Care \u002FID# 272359","East Brunswick","New Jersey","08816-4096",{"type":109,"coordinates":313},[314,315],-74.41598,40.42788,{"lat":315,"lon":314},{"facility":318,"status":102,"city":319,"state":310,"zip":320,"country":106,"countryCode":107,"cosmosGeoPoint":321,"geoPoint":325,"contacts":59},"Regional Cancer Care Associates \u002FID# 270783","Teaneck","07666",{"type":109,"coordinates":322},[323,324],-74.01597,40.8976,{"lat":324,"lon":323},{"facility":327,"status":102,"city":328,"state":329,"zip":330,"country":106,"countryCode":107,"cosmosGeoPoint":331,"geoPoint":335,"contacts":59},"Montefiore Medical Center - Einstein Campus \u002FID# 277169","The Bronx","New York","10461",{"type":109,"coordinates":332},[333,334],-73.86641,40.84985,{"lat":334,"lon":333},{"facility":337,"status":102,"city":338,"state":329,"zip":339,"country":106,"countryCode":107,"cosmosGeoPoint":340,"geoPoint":344,"contacts":59},"Clinical Research Alliance - Westbury \u002FID# 270455","Westbury","11590",{"type":109,"coordinates":341},[342,343],-73.58763,40.75566,{"lat":343,"lon":342},{"facility":346,"status":102,"city":347,"state":348,"zip":349,"country":106,"countryCode":107,"cosmosGeoPoint":350,"geoPoint":354,"contacts":59},"FirstHealth of the Carolinas- Speciality Center \u002FID# 272924","Pinehurst","North Carolina","28374",{"type":109,"coordinates":351},[352,353],-79.46948,35.19543,{"lat":353,"lon":352},{"facility":356,"status":102,"city":357,"state":358,"zip":359,"country":106,"countryCode":107,"cosmosGeoPoint":360,"geoPoint":364,"contacts":59},"Mercy Health - Perrysburg Cancer Center \u002FID# 270536","Perrysburg","Ohio","43551",{"type":109,"coordinates":361},[362,363],-83.62716,41.557,{"lat":363,"lon":362},{"facility":366,"status":102,"city":367,"state":358,"zip":368,"country":106,"countryCode":107,"cosmosGeoPoint":369,"geoPoint":373,"contacts":59},"Genesis Healthcare System \u002FID# 273361","Zanesville","43701",{"type":109,"coordinates":370},[371,372],-82.01319,39.94035,{"lat":372,"lon":371},{"facility":375,"status":102,"city":376,"state":377,"zip":378,"country":106,"countryCode":107,"cosmosGeoPoint":379,"geoPoint":383,"contacts":59},"Guthrie Robert Packer Hospital \u002FID# 270316","Sayre","Pennsylvania","18840",{"type":109,"coordinates":380},[381,382],-76.5155,41.97896,{"lat":382,"lon":381},{"facility":385,"status":102,"city":386,"state":377,"zip":387,"country":106,"countryCode":107,"cosmosGeoPoint":388,"geoPoint":392,"contacts":59},"Cancer Care Associates Of York \u002FID# 270971","York","17403",{"type":109,"coordinates":389},[390,391],-76.72774,39.9626,{"lat":391,"lon":390},{"facility":394,"status":102,"city":395,"state":396,"zip":397,"country":106,"countryCode":107,"cosmosGeoPoint":398,"geoPoint":402,"contacts":59},"Medical University of South Carolina \u002FID# 273272","Charleston","South Carolina","29425",{"type":109,"coordinates":399},[400,401],-79.93275,32.77632,{"lat":401,"lon":400},{"facility":404,"status":102,"city":405,"state":396,"zip":406,"country":106,"countryCode":107,"cosmosGeoPoint":407,"geoPoint":411,"contacts":59},"Saint Francis Cancer Center - Greenville \u002FID# 276368","Greenville","29607",{"type":109,"coordinates":408},[409,410],-82.39401,34.85262,{"lat":410,"lon":409},{"facility":413,"status":102,"city":414,"state":415,"zip":416,"country":106,"countryCode":107,"cosmosGeoPoint":417,"geoPoint":421,"contacts":59},"SCRI Oncology Partners \u002FID# 270162","Nashville","Tennessee","37203",{"type":109,"coordinates":418},[419,420],-86.78444,36.16589,{"lat":420,"lon":419},{"facility":423,"status":102,"city":424,"state":425,"zip":426,"country":106,"countryCode":107,"cosmosGeoPoint":427,"geoPoint":431,"contacts":59},"Texas Oncology - Dallas - Worth Street \u002FID# 278947","Dallas","Texas","75246",{"type":109,"coordinates":428},[429,430],-96.80667,32.78306,{"lat":430,"lon":429},{"facility":433,"status":102,"city":434,"state":425,"zip":435,"country":106,"countryCode":107,"cosmosGeoPoint":436,"geoPoint":440,"contacts":59},"Texas Oncology - Northeast Texas \u002FID# 272000","Tyler","75702",{"type":109,"coordinates":437},[438,439],-95.30106,32.35126,{"lat":439,"lon":438},{"facility":442,"status":102,"city":443,"state":444,"zip":445,"country":106,"countryCode":107,"cosmosGeoPoint":446,"geoPoint":450,"contacts":59},"Community Cancer Trials Of Utah \u002FID# 276598","Ogden","Utah","84405",{"type":109,"coordinates":447},[448,449],-111.97383,41.223,{"lat":449,"lon":448},{"facility":452,"status":102,"city":453,"state":454,"zip":455,"country":106,"countryCode":107,"cosmosGeoPoint":456,"geoPoint":460,"contacts":59},"Virginia Cancer Specialists - Fairfax \u002FID# 272004","Fairfax","Virginia","22031",{"type":109,"coordinates":457},[458,459],-77.30637,38.84622,{"lat":459,"lon":458},{"facility":462,"status":102,"city":463,"state":464,"zip":465,"country":106,"countryCode":107,"cosmosGeoPoint":466,"geoPoint":470,"contacts":59},"Medical Oncology Associates - Spokane \u002FID# 277172","Spokane","Washington","99208",{"type":109,"coordinates":467},[468,469],-117.42908,47.65966,{"lat":469,"lon":468},{"facility":472,"status":102,"city":473,"state":464,"zip":474,"country":106,"countryCode":107,"cosmosGeoPoint":475,"geoPoint":479,"contacts":59},"Northwest Medical Specialties Tacoma \u002FID# 270534","Tacoma","98405",{"type":109,"coordinates":476},[477,478],-122.44429,47.25288,{"lat":478,"lon":477},{"facility":481,"status":102,"city":482,"state":483,"zip":484,"country":485,"countryCode":486,"cosmosGeoPoint":487,"geoPoint":491,"contacts":59},"Suporte Nutricional e Quimioterapia LTDA - PRONUTRIR \u002FID# 273203","Fortaleza","Ceará","60810-180","Brazil","BR",{"type":109,"coordinates":488},[489,490],-38.54306,-3.71722,{"lat":490,"lon":489},{"facility":493,"status":102,"city":494,"state":495,"zip":496,"country":485,"countryCode":486,"cosmosGeoPoint":497,"geoPoint":501,"contacts":59},"Ictrials Pesquisa E Desenvolvimento \u002FID# 276681","Curitiba","Paraná","80510-130",{"type":109,"coordinates":498},[499,500],-49.27306,-25.42778,{"lat":500,"lon":499},{"facility":503,"status":102,"city":504,"state":505,"zip":506,"country":485,"countryCode":486,"cosmosGeoPoint":507,"geoPoint":511,"contacts":59},"Hospital De Cancer De Pernambuco \u002FID# 276104","Recife","Pernambuco","50040-000",{"type":109,"coordinates":508},[509,510],-34.88111,-8.05389,{"lat":510,"lon":509},{"facility":513,"status":102,"city":514,"state":515,"zip":516,"country":485,"countryCode":486,"cosmosGeoPoint":517,"geoPoint":521,"contacts":59},"Liga Norte Riograndense Contra O Cancer \u002FID# 273183","Natal","Rio Grande do Norte","59075-740",{"type":109,"coordinates":518},[519,520],-35.20944,-5.795,{"lat":520,"lon":519},{"facility":523,"status":102,"city":524,"state":525,"zip":526,"country":485,"countryCode":486,"cosmosGeoPoint":527,"geoPoint":531,"contacts":59},"Oncosite - Centro de Pesquisa Clinica em Oncologia \u002FID# 272513","Ijuí","Rio Grande do Sul","98700-000",{"type":109,"coordinates":528},[529,530],-53.91472,-28.38778,{"lat":530,"lon":529},{"facility":533,"status":102,"city":534,"state":535,"zip":536,"country":485,"countryCode":486,"cosmosGeoPoint":537,"geoPoint":541,"contacts":59},"Cepen - Centro De Pesquisa E Ensino Em Oncologia De Santa Catarina \u002FID# 273204","Florianópolis","Santa Catarina","88020-210",{"type":109,"coordinates":538},[539,540],-48.54917,-27.59667,{"lat":540,"lon":539},{"facility":543,"status":102,"city":544,"state":59,"zip":545,"country":485,"countryCode":486,"cosmosGeoPoint":546,"geoPoint":550,"contacts":59},"Hospital Alemao Oswaldo Cruz - Sao Paulo \u002FID# 272512","São Paulo","01323-020",{"type":109,"coordinates":547},[548,549],-46.63611,-23.5475,{"lat":549,"lon":548},{"facility":552,"status":102,"city":553,"state":554,"zip":555,"country":556,"countryCode":557,"cosmosGeoPoint":558,"geoPoint":562,"contacts":59},"Beijing Chest Tumor Hospital \u002FID# 271935","Beijing","Beijing Municipality","101149","China","CN",{"type":109,"coordinates":559},[560,561],116.39723,39.9075,{"lat":561,"lon":560},{"facility":564,"status":102,"city":565,"state":566,"zip":567,"country":556,"countryCode":557,"cosmosGeoPoint":568,"geoPoint":572,"contacts":59},"Fujian Province Cancer Hospital \u002FID# 276178","Fuzhou","Fujian","350014",{"type":109,"coordinates":569},[570,571],119.30611,26.06139,{"lat":571,"lon":570},{"facility":574,"status":102,"city":575,"state":576,"zip":577,"country":556,"countryCode":557,"cosmosGeoPoint":578,"geoPoint":582,"contacts":59},"Affiliated Cancer Hospital of Guangxi Medical University \u002FID# 271931","Nanning","Guangxi","530021",{"type":109,"coordinates":579},[580,581],108.31667,22.81667,{"lat":581,"lon":580},{"facility":584,"status":102,"city":585,"state":586,"zip":587,"country":556,"countryCode":557,"cosmosGeoPoint":588,"geoPoint":592,"contacts":59},"Harbin Medical University Cancer Hospital \u002FID# 271665","Harbin","Heilongjiang","150081",{"type":109,"coordinates":589},[590,591],126.65,45.75,{"lat":591,"lon":590},{"facility":594,"status":102,"city":595,"state":596,"zip":597,"country":556,"countryCode":557,"cosmosGeoPoint":598,"geoPoint":602,"contacts":59},"Henan Cancer Hospital \u002FID# 271927","Zhengzhou","Henan","450008",{"type":109,"coordinates":599},[600,601],113.64861,34.75778,{"lat":601,"lon":600},{"facility":604,"status":102,"city":605,"state":606,"zip":607,"country":556,"countryCode":557,"cosmosGeoPoint":608,"geoPoint":612,"contacts":59},"Union Hospital - Tongji Medical College \u002FID# 271668","Wuhan","Hubei","430022",{"type":109,"coordinates":609},[610,611],114.26667,30.58333,{"lat":611,"lon":610},{"facility":614,"status":102,"city":615,"state":616,"zip":617,"country":556,"countryCode":557,"cosmosGeoPoint":618,"geoPoint":622,"contacts":59},"The First Affiliated Hospital of Nanchang University \u002FID# 271666","Nanchang","Jiangxi","330006",{"type":109,"coordinates":619},[620,621],115.85306,28.68396,{"lat":621,"lon":620},{"facility":624,"status":102,"city":625,"state":626,"zip":627,"country":556,"countryCode":557,"cosmosGeoPoint":628,"geoPoint":632,"contacts":59},"The First Affiliated Hospital of Xi'an Jiaotong University \u002FID# 271928","Xi'an","Shaanxi","710061",{"type":109,"coordinates":629},[630,631],108.92861,34.25833,{"lat":631,"lon":630},{"facility":634,"status":102,"city":635,"state":636,"zip":637,"country":556,"countryCode":557,"cosmosGeoPoint":638,"geoPoint":642,"contacts":59},"LinYi Cancer Hospital \u002FID# 272068","Linyi","Shandong","276001",{"type":109,"coordinates":639},[640,641],118.34278,35.06306,{"lat":641,"lon":640},{"facility":644,"status":102,"city":645,"state":646,"zip":647,"country":556,"countryCode":557,"cosmosGeoPoint":648,"geoPoint":652,"contacts":59},"Cancer Hospital Affliated to Xinjiang Medical University \u002FID# 271933","Ürümqi","Xinjiang","830011",{"type":109,"coordinates":649},[650,651],87.60046,43.80096,{"lat":651,"lon":650},{"facility":654,"status":102,"city":655,"state":656,"zip":657,"country":658,"countryCode":659,"cosmosGeoPoint":660,"geoPoint":664,"contacts":59},"Meir Medical Center \u002FID# 270071","Kefar Sava","Central District","4428164","Israel","IL",{"type":109,"coordinates":661},[662,663],34.90694,32.175,{"lat":663,"lon":662},{"facility":666,"status":102,"city":667,"state":656,"zip":668,"country":658,"countryCode":659,"cosmosGeoPoint":669,"geoPoint":673,"contacts":59},"Rabin Medical Center. \u002FID# 270087","Petah Tikva","4941492",{"type":109,"coordinates":670},[671,672],34.88666,32.0888,{"lat":672,"lon":671},{"facility":675,"status":102,"city":676,"state":677,"zip":678,"country":658,"countryCode":659,"cosmosGeoPoint":679,"geoPoint":683,"contacts":59},"The Chaim Sheba Medical Center \u002FID# 270068","Ramat Gan","Tel Aviv","5265601",{"type":109,"coordinates":680},[681,682],34.81065,32.08227,{"lat":682,"lon":681},{"facility":685,"status":102,"city":686,"state":59,"zip":687,"country":658,"countryCode":659,"cosmosGeoPoint":688,"geoPoint":692,"contacts":59},"Rambam Health Care Campus- Haifa \u002FID# 270078","Haifa","3109601",{"type":109,"coordinates":689},[690,691],34.99928,32.81303,{"lat":691,"lon":690},{"facility":694,"status":232,"city":695,"state":59,"zip":696,"country":658,"countryCode":659,"cosmosGeoPoint":697,"geoPoint":701,"contacts":59},"Shaare Zedek Medical Center \u002FID# 270095","Jerusalem","9103102",{"type":109,"coordinates":698},[699,700],35.21633,31.76904,{"lat":700,"lon":699},{"facility":703,"status":102,"city":704,"state":705,"zip":706,"country":707,"countryCode":708,"cosmosGeoPoint":709,"geoPoint":713,"contacts":59},"Nagoya University Hospital \u002FID# 277010","Nagoya","Aichi-ken","466-8560","Japan","JP",{"type":109,"coordinates":710},[711,712],136.90641,35.18147,{"lat":712,"lon":711},{"facility":715,"status":102,"city":716,"state":717,"zip":718,"country":707,"countryCode":708,"cosmosGeoPoint":59,"geoPoint":59,"contacts":59},"National Cancer Center Hospital East \u002FID# 277056","Kashiwa-shi","Chiba","277-8577",{"facility":720,"status":102,"city":721,"state":722,"zip":723,"country":707,"countryCode":708,"cosmosGeoPoint":724,"geoPoint":728,"contacts":59},"Hokkaido University Hospital \u002FID# 277014","Sapporo","Hokkaido","060-8648",{"type":109,"coordinates":725},[726,727],141.35,43.06667,{"lat":727,"lon":726},{"facility":730,"status":102,"city":731,"state":732,"zip":733,"country":707,"countryCode":708,"cosmosGeoPoint":734,"geoPoint":738,"contacts":59},"Kobe Minimally Invasive Cancer Center \u002FID# 277469","Kobe","Hyōgo","650-0046",{"type":109,"coordinates":735},[736,737],135.183,34.6913,{"lat":737,"lon":736},{"facility":740,"status":102,"city":741,"state":742,"zip":743,"country":707,"countryCode":708,"cosmosGeoPoint":59,"geoPoint":59,"contacts":59},"Kitasato University Hospital \u002FID# 277012","Sagamihara-shi","Kanagawa","252-0375",{"facility":745,"status":102,"city":746,"state":747,"zip":748,"country":707,"countryCode":708,"cosmosGeoPoint":749,"geoPoint":753,"contacts":59},"Sendai Kousei Hospital \u002FID# 277023","Sendai","Miyagi","981-0914",{"type":109,"coordinates":750},[751,752],140.86667,38.26667,{"lat":752,"lon":751},{"facility":755,"status":102,"city":756,"state":756,"zip":757,"country":707,"countryCode":708,"cosmosGeoPoint":758,"geoPoint":762,"contacts":59},"University of Miyazaki Hospital \u002FID# 277020","Miyazaki","889-1692",{"type":109,"coordinates":759},[760,761],131.41667,31.91667,{"lat":761,"lon":760},{"facility":764,"status":102,"city":765,"state":766,"zip":767,"country":707,"countryCode":708,"cosmosGeoPoint":59,"geoPoint":59,"contacts":59},"Kurashiki Central Hospital \u002FID# 276995","Kurashiki-shi","Okayama-ken","710-8602",{"facility":769,"status":102,"city":770,"state":771,"zip":772,"country":707,"countryCode":708,"cosmosGeoPoint":773,"geoPoint":777,"contacts":59},"Fujieda Municipal General Hospital \u002FID# 277025","Fujieda","Shizuoka","426-0077",{"type":109,"coordinates":774},[775,776],138.26667,34.86667,{"lat":776,"lon":775},{"facility":779,"status":102,"city":780,"state":780,"zip":781,"country":707,"countryCode":708,"cosmosGeoPoint":782,"geoPoint":786,"contacts":59},"Wakayama Medical University Hospital \u002FID# 276997","Wakayama","641-8510",{"type":109,"coordinates":783},[784,785],135.16667,34.23333,{"lat":785,"lon":784},{"facility":788,"status":102,"city":789,"state":790,"zip":791,"country":792,"countryCode":793,"cosmosGeoPoint":794,"geoPoint":798,"contacts":59},"Institute for Oncology and Radiology of Serbia \u002FID# 270561","Belgrade","Beograd","11000","Serbia","RS",{"type":109,"coordinates":795},[796,797],20.46513,44.80401,{"lat":797,"lon":796},{"facility":800,"status":102,"city":789,"state":790,"zip":791,"country":792,"countryCode":793,"cosmosGeoPoint":801,"geoPoint":803,"contacts":59},"Military Medical Academy \u002FID# 279873",{"type":109,"coordinates":802},[796,797],{"lat":797,"lon":796},{"facility":805,"status":102,"city":789,"state":790,"zip":791,"country":792,"countryCode":793,"cosmosGeoPoint":806,"geoPoint":808,"contacts":59},"University Clinical Center Serbia \u002FID# 270808",{"type":109,"coordinates":807},[796,797],{"lat":797,"lon":796},{"facility":810,"status":102,"city":789,"state":790,"zip":811,"country":792,"countryCode":793,"cosmosGeoPoint":812,"geoPoint":814,"contacts":59},"Clinical Hospital Center - Bezanijska Kosa \u002FID# 270558","11080",{"type":109,"coordinates":813},[796,797],{"lat":797,"lon":796},{"facility":816,"status":102,"city":817,"state":818,"zip":819,"country":792,"countryCode":793,"cosmosGeoPoint":820,"geoPoint":824,"contacts":59},"University Clinical Center Nis \u002FID# 270557","Niš","Nisavski Okrug","18300",{"type":109,"coordinates":821},[822,823],21.90333,43.32472,{"lat":823,"lon":822},{"facility":826,"status":102,"city":827,"state":828,"zip":829,"country":792,"countryCode":793,"cosmosGeoPoint":830,"geoPoint":834,"contacts":59},"Institute For Pulmonary Diseases Of Vojvodina \u002FID# 270559","Kamenitz","Sremski Okrug","21208",{"type":109,"coordinates":831},[832,833],19.84263,45.22334,{"lat":833,"lon":832},{"facility":836,"status":102,"city":837,"state":838,"zip":839,"country":792,"countryCode":793,"cosmosGeoPoint":840,"geoPoint":844,"contacts":59},"University Clinical Center Kragujevac \u002FID# 275773","Kragujevac","Sumadijski Okrug","34000",{"type":109,"coordinates":841},[842,843],20.91667,44.01667,{"lat":843,"lon":842},{"facility":846,"status":102,"city":847,"state":848,"zip":849,"country":847,"countryCode":850,"cosmosGeoPoint":851,"geoPoint":855,"contacts":59},"National Cancer Centre Singapore \u002FID# 271499","Singapore","Central Singapore","169611","SG",{"type":109,"coordinates":852},[853,854],103.85007,1.28967,{"lat":854,"lon":853},{"facility":857,"status":102,"city":847,"state":59,"zip":858,"country":847,"countryCode":850,"cosmosGeoPoint":859,"geoPoint":861,"contacts":59},"National University Hospital \u002FID# 271700","119074",{"type":109,"coordinates":860},[853,854],{"lat":854,"lon":853},{"type":863,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"SPONSOR","100559807","phase-2-a-study-to-assess-adverse-events-and-how-intravenously-iv-infused-telisotuzumab-vedotin-abbv-399-moves-through-the-body-as-a-monotherapy-in-adult-participants-with-previously-treated-non-squamous-non-small-cell-lung-cancer-nsclc-100559807",false,"NCT06568939","A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)","A Phase 2, Open-Label, Randomized, Global Study of Three Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced\u002FMetastatic Non-Squamous Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Projected life expectancy of at least 12 weeks.\n* Must have c-Met overexpressing non-small cell lung cancer (NSCLC) (defined as \\>= 25% tumor cells with 3+ staining (high \\[\\>= 50% 3+\\]; intermediate \\[\\>= 25% - \\\u003C 50%\\]) as assessed by a Sponsor designated immunohistochemistry (IHC) laboratory\n* Must have histologically or cytologically documented NSCLC that is locally advanced or metastatic.\n* Must have a known epidermal growth factor receptor (EGFR) activating mutation status.\n* Actionable alterations in genes other than EGFR are permitted.\n* Must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n* Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n* Must have received no more than 1 line of prior systemic cytotoxic chemotherapy in the locally advanced or metastatic setting, as stated in the protocol.\n* Must have progressed on at least 1 line of prior therapy for locally advanced\u002Fmetastatic NSCLC, as stated in the protocol.\n\nExclusion Criteria:\n\n* Adenosquamous or neuroendocrine histology, or sarcomatoid features.\n* EGFR activating mutations (e.g., EGFR Exon 19 deletions, T790M, Exon 21 L858R, or Exon 20 insertion mutations).\n* Received prior c-Met-targeted antibodies, prior telisotuzumab vedotin, or prior antibody-drug conjugates either targeting c-Met or consisting of monomethylauristatin E.\n* Received prior docetaxel therapy.\n* Metastases to the central nervous system (CNS). Participants with CNS metastases are eligible only after adequate treatment (such as surgery or, radiotherapy, or drug therapy) is provided, as stated on the protocol.\n* History of other malignancies except those stated in the protocol.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan, as noted in the protocol.\n* Unresolved clinically significant adverse event (AE) \\>= Grade 2 from prior anticancer therapy, except for alopecia or anemia. Participants with hormone deficiencies caused by prior anticancer therapy who are asymptomatic and on a stable dose of replacement hormone are eligible for study.\n* Major surgery within 21 days prior to randomization.\n* Clinically significant condition(s) including but not limited to those listed in the protocol.\n* Clinically significant liver disease, including hepatitis, current alcohol abuse, or cirrhosis.\n* Grade \\>= 2 edema or lymphedema.\n* Grade \\>= 2 ascites or pleural effusion.\n* Grade \\>= 2 neuropathy.\n* Active uncontrolled bacterial or viral infection.\n* Active corneal disorder.","ALL","18 Years",{"count":874,"type":875},150,"ESTIMATED","INTERVENTIONAL",[878],"PHASE2","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 assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed.\n\nTelisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide.\n\nParticipants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration.\n\nThere 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.",[881],"Non-Small Cell Lung Cancer",[881,883,84,88,884],"NSCLC","TeliMET NSCLC-04","2026-09-11",{"date":887,"type":888},"2026-09-15","ACTUAL",{"date":890,"type":888},"2025-01-20",{"date":892,"type":875},"2028-02",{"name":5,"class":6},81]