Uno studio sulla chemioterapia e su Ramucirumab rispetto alla sola chemioterapia nei partecipanti con carcinoma polmonare non a piccole cellule (NSCLC) di seconda linea che hanno ricevuto in precedenza chemioterapia a base di platino di prima linea
10 settembre 2019 aggiornato da: Eli Lilly and Company
Uno studio randomizzato, in doppio cieco, di fase 3 su docetaxel e ramucirumab rispetto a docetaxel e placebo nel trattamento del carcinoma polmonare non a piccole cellule in stadio IV dopo la progressione della malattia dopo una precedente terapia a base di platino
Lo scopo dello studio è confrontare la sopravvivenza dei partecipanti che ricevono chemioterapia e ramucirumab rispetto alla sola chemioterapia come trattamento di seconda linea per NSCLC dopo una precedente chemioterapia di prima linea a base di platino.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1253
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Buenos Aires, Argentina, C1417EYG
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Córdoba, Argentina, X5016KEH
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La Rioja, Argentina, 5300
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Rosario, Argentina, 2000
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Tucumain, Argentina, 4000
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Viedma, Argentina, 8500
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Graz, Austria, 8036
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Grimmenstein, Austria, 2840
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Vienna, Austria, A-1140
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Wels, Austria, 4600
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Barretos, Brasile, 14784700
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Belo Horizonte, Brasile, 31110580
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Goiania, Brasile, 74140050
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Porto Alegre, Brasile, 90430-090
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São Paulo, Brasile, 1224010
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
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New Brunswick
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Moncton, New Brunswick, Canada, E1C 6Z8
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Quebec
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Sainte-Foy, Quebec, Canada, G1V 4G5
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Incheon, Corea, Repubblica di, 405-760
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Seoul, Corea, Repubblica di, 120-752
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Suwon-City, Corea, Repubblica di, 442-723
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Moscow, Federazione Russa, 115478
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Saint Petersburg, Federazione Russa, 197758
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Stavropol, Federazione Russa, 355047
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Grenoble, Francia, 38049
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Lille, Francia, 59037
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Lyon, Francia, 69373
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Nice, Francia, 06050
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Strasbourg, Francia, 67091
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Toulouse, Francia, 31059
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Vandoeuvre Les Nancy, Francia, 54511
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Augsburg, Germania, 86150
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Bad Soden, Germania, 65812
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Bielefeld, Germania, 33611
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Dresden, Germania, 01307
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Frankfurt, Germania, 60596
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Gerlingen, Germania, 70839
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Großhansdorf, Germania, 22927
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Halle, Germania, 06120
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Heidelberg, Germania, 69126
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Immenhausen, Germania, 34376
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Oldenburg, Germania, 26121
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Ulm, Germania, 89081
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Villingen-Schwenningen, Germania, 78050
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Athens, Grecia, 10676
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Chania, Grecia, 73300
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Kifissia, Grecia, 14564
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Patras, Grecia, 26500
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Bangalore, India, 560099
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Cuttack, India, 753007
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Delhi, India, 110085
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Jaipur, India, 302017
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Kochin, India, 628040
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Madurai, India, 625020
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Mumbai, India, 400 012
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Pune, India, 411001
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Trivandrum, India, 695 011
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Haifa, Israele, 31096
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Jerusalem, Israele, 91120
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Kfar Saba, Israele, 44281
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Petah Tikva, Israele, 49100
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Safed, Israele, 13110
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Tel-Aviv, Israele, 64239
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Livorno, Italia, 57124
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Monza, Italia, 20900
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Novara, Italia, 28100
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Padova, Italia, 35128
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Palermo, Italia, 90146
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Parma, Italia, 43100
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Pisa, Italia, 56124
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Rome, Italia, 00152
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Guadalajara, Messico, 44280
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Mexico City, Messico, 14000
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Oslo, Norvegia, 0310
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Tromsø, Norvegia, 9012
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Grafton, Nuova Zelanda, 1023
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Wellington, Nuova Zelanda, 6002
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Amsterdam, Olanda, 1091AC
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Arnhem, Olanda, 6815 AD
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Harderwijk, Olanda, 3844 DG
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S-Hertogenbosch, Olanda, 5223 GZ
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Zwolle, Olanda, 80211 JW
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Gdansk, Polonia, 80-219
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Gdynia, Polonia, 81-519
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Glucholazy, Polonia, 48-340
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Krakow, Polonia, 31-202
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Lodz, Polonia, 90-242
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Opole, Polonia, 45-060
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Otwock, Polonia, 05-400
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Poznan, Polonia, 60-693
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Bayamon, Porto Rico, 00959
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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East Yorkshire
-
Cottingham, East Yorkshire, Regno Unito, HU16 5JQ
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Greater London
-
London, Greater London, Regno Unito, W6 8RF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Lancashire
-
Preston, Lancashire, Regno Unito, PR2 9HT
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Manchester
-
Wythenshawe, Manchester, Regno Unito, M23 9LT
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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North Lincolnshire
-
Scunthorpe, North Lincolnshire, Regno Unito, DN15 7BH
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Scotland
-
Glasgow, Scotland, Regno Unito, G12 0YN
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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West Midlands
-
Coventry, West Midlands, Regno Unito, CV2 2DX
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Wolverhampton, West Midlands, Regno Unito, WV10 0QP
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bucharest, Romania, 022328
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Cluj-Napoca, Romania, 400058
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Iasi, Romania, 700106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Barcelona, Spagna, 08003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Girona, Spagna, 17007
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Las Palmas De Gran Canaria, Spagna, 35016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Madrid, Spagna, 28050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Mataró, Spagna, 08304
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pamplona, Spagna, 31008
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Pozuelo De Alarcon, Spagna, 28223
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Arizona
-
Phoenix, Arizona, Stati Uniti, 85016
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Sedona, Arizona, Stati Uniti, 86336
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Arkansas
-
Fayetteville, Arkansas, Stati Uniti, 72703
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
California
-
Alhambra, California, Stati Uniti, 91801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Duarte, California, Stati Uniti, 91010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Fresno, California, Stati Uniti, 93720
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Fullerton, California, Stati Uniti, 92835
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
La Jolla, California, Stati Uniti, 92093
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Long Beach, California, Stati Uniti, 90813
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Los Angeles, California, Stati Uniti, 90095
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Northridge, California, Stati Uniti, 91325
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Redondo Beach, California, Stati Uniti, 90277
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Santa Barbara, California, Stati Uniti, 93105
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Santa Monica, California, Stati Uniti, 93454
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Colorado
-
Denver, Colorado, Stati Uniti, 80218
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
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Connecticut
-
Waterbury, Connecticut, Stati Uniti, 06708
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Florida
-
Jacksonville, Florida, Stati Uniti, 32204
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Miami, Florida, Stati Uniti, 33176
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ocala, Florida, Stati Uniti, 34471
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Orlando, Florida, Stati Uniti, 32806
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Georgia
-
Athens, Georgia, Stati Uniti, 30607
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Augusta, Georgia, Stati Uniti, 30901
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Lawrenceville, Georgia, Stati Uniti, 30045
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Macon, Georgia, Stati Uniti, 31201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Rome, Georgia, Stati Uniti, 30165
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Savannah, Georgia, Stati Uniti, 31405
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Illinois
-
Springfield, Illinois, Stati Uniti, 62703
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Indiana
-
Bloomington, Indiana, Stati Uniti, 47402
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Iowa
-
Cedar Rapids, Iowa, Stati Uniti, 52402
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Iowa City, Iowa, Stati Uniti, 52242
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Kansas
-
Overland Park, Kansas, Stati Uniti, 66210
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Wichita, Kansas, Stati Uniti, 67214
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Kentucky
-
Ashland, Kentucky, Stati Uniti, 41101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Mount Sterling, Kentucky, Stati Uniti, 40353
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Louisiana
-
Baton Rouge, Louisiana, Stati Uniti, 70809
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Metairie, Louisiana, Stati Uniti, 70006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20817
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Chevy Chase, Maryland, Stati Uniti, 20815
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02115
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Danvers, Massachusetts, Stati Uniti, 01923
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Framingham, Massachusetts, Stati Uniti, 01701
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Newton, Massachusetts, Stati Uniti, 02462
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Minnesota
-
Minneapolis, Minnesota, Stati Uniti, 55404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Missouri
-
Columbia, Missouri, Stati Uniti, 65201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Joplin, Missouri, Stati Uniti, 64804
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Saint Louis, Missouri, Stati Uniti, 63110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Montana
-
Billings, Montana, Stati Uniti, 59101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Nevada
-
Henderson, Nevada, Stati Uniti, 89169
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Reno, Nevada, Stati Uniti, 89502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Hampshire
-
Lebanon, New Hampshire, Stati Uniti, 03756
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Portsmouth, New Hampshire, Stati Uniti, 03801
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New Mexico
-
Albuquerque, New Mexico, Stati Uniti, 87109
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
New York
-
Bronx, New York, Stati Uniti, 10467
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Latham, New York, Stati Uniti, 12110
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
New York, New York, Stati Uniti, 10021
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
North Carolina
-
Durham, North Carolina, Stati Uniti, 27704
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Raleigh, North Carolina, Stati Uniti, 27607
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
North Dakota
-
Fargo, North Dakota, Stati Uniti, 58122
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Ohio
-
Columbus, Ohio, Stati Uniti, 43219
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Oklahoma
-
Tulsa, Oklahoma, Stati Uniti, 74136
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Pennsylvania
-
Abington, Pennsylvania, Stati Uniti, 19001
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Kingston, Pennsylvania, Stati Uniti, 18704
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Philadelphia, Pennsylvania, Stati Uniti, 19106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
South Carolina
-
Charleston, South Carolina, Stati Uniti, 29414
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
South Dakota
-
Sioux Falls, South Dakota, Stati Uniti, 57104
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Tennessee
-
Chattanooga, Tennessee, Stati Uniti, 37403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Memphis, Tennessee, Stati Uniti, 38138
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
Texas
-
Abilene, Texas, Stati Uniti, 79606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Amarillo, Texas, Stati Uniti, 79106
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Beaumont, Texas, Stati Uniti, 77702
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Bedford, Texas, Stati Uniti, 76022
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Dallas, Texas, Stati Uniti, 75231
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El Paso, Texas, Stati Uniti, 79915
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Fort Worth, Texas, Stati Uniti, 76104
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Lewisville, Texas, Stati Uniti, 75067
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McAllen, Texas, Stati Uniti, 78503
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Mesquite, Texas, Stati Uniti, 75150
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Midland, Texas, Stati Uniti, 79701
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Odessa, Texas, Stati Uniti, 79761
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Paris, Texas, Stati Uniti, 75460
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San Antonio, Texas, Stati Uniti, 78229
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San Antonio, Texas, Stati Uniti, 78212
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Sherman, Texas, Stati Uniti, 75090
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Sugar Land, Texas, Stati Uniti, 77479
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The Woodlands, Texas, Stati Uniti, 77380
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Tyler, Texas, Stati Uniti, 75702
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Webster, Texas, Stati Uniti, 77598
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Wichita Falls, Texas, Stati Uniti, 76310
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Virginia
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Christiansburg, Virginia, Stati Uniti, 24073
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Fairfax, Virginia, Stati Uniti, 22031
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Newport News, Virginia, Stati Uniti, 23601
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Richmond, Virginia, Stati Uniti, 23298
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Washington
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Lacey, Washington, Stati Uniti, 98503
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Spokane, Washington, Stati Uniti, 99216
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Wenatchee, Washington, Stati Uniti, 98801
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Wisconsin
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Madison, Wisconsin, Stati Uniti, 53705
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Eskilstuna, Svezia, 63188
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Linkoping, Svezia, 58185
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Lund, Svezia, 22185
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Solna, Svezia, 17176
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Basel, Svizzera, CH-4031
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Bern, Svizzera, CH-3010
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Fribourg, Svizzera, 1708
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Luzern, Svizzera, CH-6000
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Zurich, Svizzera, CH-8091
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Ankara, Tacchino, 06500
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Istanbul, Tacchino, 81540
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Izmir, Tacchino, 35340
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Kayseri, Tacchino, 38039
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Kaohsiung, Taiwan, 813
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Kuei Shan Hsiang, Taiwan, 33305
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Neihu Taipei, Taiwan, 114
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Niao Sung Hsiang, Taiwan, 833
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Taichung, Taiwan, 40705
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Taipei, Taiwan, 11031
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Budapest, Ungheria, 1145
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Gyula, Ungheria, 5703
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Matrahaza, Ungheria, 3233
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Nyiregyhaza, Ungheria, 4412
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Pécs, Ungheria, 7623
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Szekesfehervar, Ungheria, 8000
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Criterio di inclusione:
- Progressione della malattia durante o dopo una precedente chemioterapia di prima linea a base di platino con o senza terapia di mantenimento
- È consentito un precedente trattamento con bevacizumab come terapia di prima linea e/o di mantenimento
- Consenso informato firmato
- Performance status dell'Eastern Cooperative Oncology Group (ECOG) di 0-1
- NSCLC confermato istologicamente o citologicamente
- Malattia NSCLC in stadio IV
- I partecipanti hanno una malattia misurabile o non misurabile
Adeguata funzione d'organo, definita come:
- Bilirubina totale inferiore o uguale al limite superiore della norma (ULN),
- Aspartato aminotransferasi (AST) e alanina aminotransaminasi (ALT) inferiori o uguali a 2,5 x ULN, o inferiori o uguali a 5 x ULN se l'aumento della transferasi è dovuto a metastasi epatiche,
- Creatinina sierica inferiore o uguale a 1,5 x ULN o clearance della creatinina calcolata superiore o uguale a 50 millilitri al minuto (ml/min) (secondo la formula di Cockcroft-Gault o equivalente e/o raccolta delle urine delle 24 ore),
- Conta assoluta dei neutrofili (ANC) maggiore o uguale a 1,5 x 10^3/microlitri (µL), emoglobina maggiore o uguale a 10,0 grammi/decilitro (g/dL) e piastrine maggiori o uguali a 100 x 10^3 /ml,
- Adeguata funzione della coagulazione come definita dall'International Normalized Ratio (INR) inferiore o uguale a 1,5, o tempo di protrombina e tempo di tromboplastina parziale inferiore o uguale a 1,5 x ULN.
- Il partecipante non ha cirrosi a livello di Child-Pugh B (o peggiore) o cirrosi (qualsiasi grado) e una storia di encefalopatia epatica o ascite clinicamente significativa derivante dalla cirrosi. L'ascite clinicamente significativa è definita come ascite derivante da cirrosi e che richiede un trattamento continuo con diuretici e/o paracentesi.
- Le proteine urinarie sono inferiori o uguali a 1+ sul dipstick o sull'analisi delle urine di routine. Se il dipstick delle urine o l'analisi di routine indica proteinuria maggiore o uguale a 2+, deve essere raccolta un'urina delle 24 ore e deve dimostrare meno di 1000 milligrammi (mg) di proteine.
- I partecipanti con potenziale riproduttivo (entrambi i sessi) devono accettare di utilizzare un metodo affidabile di controllo delle nascite (metodi ormonali o di barriera) durante il periodo di studio e almeno 12 settimane dopo l'ultima dose della terapia in studio
- Aspettativa di vita maggiore o uguale a 3 mesi
- La precedente radioterapia è consentita se: nel caso di radioterapia toracica sono trascorsi almeno 28 giorni dal completamento del trattamento radioterapico prima della randomizzazione; In caso di radioterapia focale o palliativa, sono trascorsi almeno 7 giorni dall'ultima radioterapia prima della randomizzazione (e a condizione che il 25% o meno del midollo osseo totale sia stato irradiato); Nel caso di radiazioni del Sistema Nervoso Centrale (SNC) sono trascorsi almeno 14 giorni dal completamento del trattamento radioterapico prima della randomizzazione
Criteri di esclusione:
- Progressione della malattia su più di 1 precedente regime chemioterapico
- - Partecipanti il cui unico trattamento precedente era un inibitore della tirosina chinasi
- Il tumore del partecipante contiene in tutto o in parte carcinoma polmonare a piccole cellule
- Intervento chirurgico maggiore entro 28 giorni prima della randomizzazione o posizionamento di un dispositivo di accesso venoso sottocutaneo entro 7 giorni prima della randomizzazione. Complicanze emorragiche postoperatorie o complicanze della ferita da una procedura chirurgica eseguita negli ultimi 2 mesi.
- Trattamento concomitante con altra terapia antitumorale, inclusa altra chemioterapia, immunoterapia, terapia ormonale, chemioembolizzazione o terapia mirata
- L'ultima dose di bevacizumab deve essere di almeno 28 giorni dal momento della randomizzazione
- L'ultima dose di chemioterapia citotossica deve essere di almeno 14 giorni dal momento della randomizzazione
- Il partecipante ha metastasi del SNC non trattate. I partecipanti con metastasi cerebrali trattate sono idonei se sono clinicamente stabili per quanto riguarda la funzione neurologica, senza steroidi dopo l'irradiazione cranica terminata almeno 2 settimane prima della randomizzazione o dopo resezione chirurgica eseguita almeno 28 giorni prima della randomizzazione. Nessuna evidenza di emorragia del SNC di grado maggiore o uguale a 1 sulla base della risonanza magnetica per immagini (MRI) o della tomografia computerizzata (TC) con contrasto IV pretrattamento.
- Evidenza radiologicamente documentata di invasione o rivestimento di vasi sanguigni importanti da parte del cancro
- Evidenza radiografica di cavitazione intratumorale
- Storia di disturbo trombotico ereditario o acquisito non controllato
- Terapia cronica con farmaci antinfiammatori non steroidei (FANS) o altri agenti antipiastrinici; È consentito l'uso di aspirina a dosi fino a 325 milligrammi al giorno (mg/giorno).
- Storia di emottisi macroscopica (definita come sangue rosso vivo o maggiore o uguale a 1/2 cucchiaino) entro 2 mesi prima della randomizzazione
- Insufficienza cardiaca congestizia clinicamente rilevante [New York Heart Association (NYHA II-IV)] o aritmia cardiaca sintomatica o scarsamente controllata
- Qualsiasi evento trombotico arterioso, inclusi infarto miocardico, angina instabile, accidente cerebrovascolare o attacco ischemico transitorio, nei 6 mesi precedenti la randomizzazione
- Ipertensione arteriosa incontrollata maggiore o uguale a 150 / maggiore o uguale a 90 millimetri di mercurio (mm Hg) nonostante la gestione medica standard
- - Ferita, ulcera o frattura ossea grave o non cicatrizzante entro 28 giorni prima della randomizzazione
- Disturbi emorragici significativi, vasculite o sanguinamento gastrointestinale di grado 3/4 entro 3 mesi prima della randomizzazione
- Perforazione e/o fistole gastrointestinali (GI) nei 6 mesi precedenti la randomizzazione
- Ostruzione intestinale, anamnesi o presenza di enteropatia infiammatoria o ampia resezione intestinale Morbo di Crohn, colite ulcerosa o diarrea cronica
- Neuropatia periferica maggiore o uguale al grado 2 [Criteri comuni di terminologia per gli eventi avversi del National Cancer Institute (NCI-CTCAE) versione 4.02]
- Malattie gravi o condizioni mediche incluse, ma non limitate a: Infezione da virus dell'immunodeficienza umana (HIV) o malattia correlata alla sindrome da immunodeficienza acquisita (AIDS); Infezione clinicamente grave attiva o incontrollata; Grave condizione medica o psichiatrica acuta o cronica o anomalia di laboratorio che può aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco oggetto dello studio
- Allergia nota o reazione di ipersensibilità a uno qualsiasi dei componenti del trattamento
- Il partecipante è incinta o sta allattando
- Trattamento in corso o recente (entro 28 giorni prima della randomizzazione) con un farmaco o dispositivo sperimentale che non ha ricevuto l'approvazione normativa per alcuna indicazione al momento della randomizzazione o partecipazione a un altro studio clinico interventistico
- Precedente terapia con docetaxel
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Ramucirumab + Docetaxel
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10 milligrammi per chilogrammo (mg/kg) somministrati per via endovenosa (IV) il giorno 1 di un ciclo di 21 giorni fino a quando non viene soddisfatta la progressione della malattia, tossicità inaccettabile o un altro criterio di sospensione
Altri nomi:
75 milligrammi per metro quadrato (mg/m^2) (60 mg/m^2 per i paesi di Corea e Taiwan solo con modifica del protocollo datata 22 maggio 2012) somministrati IV il giorno 1 del ciclo di 21 giorni fino alla progressione della malattia, inaccettabile tossicità, o un altro criterio di ritiro è soddisfatto
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Comparatore placebo: Placebo + docetaxel
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75 milligrammi per metro quadrato (mg/m^2) (60 mg/m^2 per i paesi di Corea e Taiwan solo con modifica del protocollo datata 22 maggio 2012) somministrati IV il giorno 1 del ciclo di 21 giorni fino alla progressione della malattia, inaccettabile tossicità, o un altro criterio di ritiro è soddisfatto
Somministrato EV il giorno 1 del ciclo di 21 giorni fino a quando non viene soddisfatta la progressione della malattia, tossicità inaccettabile o un altro criterio di sospensione
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sopravvivenza globale
Lasso di tempo: Randomizzazione fino alla data di morte per qualsiasi causa (fino a 34 mesi)
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La sopravvivenza globale era il tempo dalla randomizzazione fino alla data di morte per qualsiasi causa.
I partecipanti che erano vivi alla fine del periodo di follow-up (o persi al follow-up) sono stati censurati nell'ultima data in cui si sapeva che il partecipante era vivo.
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Randomizzazione fino alla data di morte per qualsiasi causa (fino a 34 mesi)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Tempo di sopravvivenza libera da progressione (PFS).
Lasso di tempo: Randomizzazione per PD misurata o data di morte per qualsiasi causa (fino a 29 mesi)
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Il tempo di PFS era il tempo dalla randomizzazione fino alla data della malattia progressiva (PD) oggettivamente determinata o del decesso dovuto a qualsiasi causa, a seconda di quale si fosse verificata per prima.
Secondo i criteri di valutazione della risposta nei tumori solidi versione 1.1 (RECIST v1.1), il PD è stato un aumento di almeno il 20% nella somma dei diametri delle lesioni target, prendendo come riferimento la somma più piccola nello studio.
Oltre all'aumento relativo del 20%, la somma deve aver dimostrato anche un aumento assoluto di almeno 5 millimetri (mm).
Anche la comparsa di 1 o più nuove lesioni e/o la progressione inequivocabile di lesioni esistenti non target è stata considerata progressione.
I partecipanti senza PD oggettivamente determinato che erano vivi alla fine del periodo di follow-up (o persi al follow-up) sono stati censurati alla data dell'ultima valutazione radiografica completa del tumore del partecipante; se non era disponibile alcuna valutazione radiologica al basale o post-basale, il partecipante è stato censurato alla data della randomizzazione.
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Randomizzazione per PD misurata o data di morte per qualsiasi causa (fino a 29 mesi)
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Percentuale di partecipanti che ottengono una risposta obiettiva (tasso di risposta obiettiva)
Lasso di tempo: Dal basale alla PD misurata (fino a 29 mesi)
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I partecipanti hanno ottenuto una risposta obiettiva se hanno avuto una migliore risposta complessiva di risposta parziale (PR) o risposta completa (CR).
Secondo RECIST v1.1, PR è stato definito come una diminuzione di almeno il 30% della somma dei diametri delle lesioni target (compresi gli assi corti di qualsiasi linfonodo target), prendendo come riferimento la somma del diametro basale; CR era la scomparsa di tutte le lesioni bersaglio non linfonodali, con gli assi corti di qualsiasi linfonodo bersaglio ridotti a <10 mm, la scomparsa di tutte le lesioni non bersaglio e la normalizzazione dei livelli dei marcatori tumorali [se i marcatori tumorali erano inizialmente al di sopra del limite di normalità (ULN)].
La percentuale di partecipanti che hanno ottenuto una risposta obiettiva=(numero di partecipanti con CR o PR)/(numero di partecipanti valutati)*100.
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Dal basale alla PD misurata (fino a 29 mesi)
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Percentuale di partecipanti che ottengono il controllo delle malattie (tasso di controllo delle malattie)
Lasso di tempo: Dal basale alla PD misurata (fino a 29 mesi)
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I partecipanti hanno raggiunto il controllo della malattia se avevano una migliore risposta complessiva di PR, CR o malattia stabile (SD).
Secondo RECIST v1.1, PR è stato definito come una diminuzione di almeno il 30% della somma dei diametri delle lesioni target (compresi gli assi corti di qualsiasi linfonodo target), prendendo come riferimento la somma del diametro basale; CR era la scomparsa di tutte le lesioni bersaglio non linfonodali, con l'asse corto di qualsiasi linfonodo bersaglio ridotto a <10 mm, la scomparsa di tutte le lesioni non bersaglio e la normalizzazione dei livelli dei marcatori tumorali (se i marcatori tumorali erano inizialmente al di sopra dell'ULN ).
La SD non era né un restringimento sufficiente per qualificarsi come PR né un aumento sufficiente per qualificarsi come PD, prendendo come riferimento il diametro totale più piccolo dall'inizio del trattamento.
La percentuale di partecipanti che hanno raggiunto il controllo della malattia=(numero di partecipanti con CR, PR o SD)/(numero di partecipanti valutati)*100.
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Dal basale alla PD misurata (fino a 29 mesi)
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Miglioramento massimo sulla scala dei sintomi del cancro al polmone (LCSS)
Lasso di tempo: Basale, giorno 21 di ciascun ciclo e 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Il LCSS consisteva di 9 item: 6 item focalizzati sui sintomi del cancro del polmone [perdita di appetito, affaticamento, tosse, dispnea (mancanza di respiro), emottisi (sangue nell'espettorato) e dolore] e 3 item erano item globali (sintomo distress, interferenza con il livello di attività e la qualità globale della vita).
Le risposte dei partecipanti a ciascun elemento sono state misurate utilizzando scale analogiche visive (VAS) con linee da 100 mm.
Un punteggio più alto per qualsiasi elemento rappresentava un livello più alto di sintomi/problemi.
L'Average Symptom Burden Index (ASBI) era la media dei 6 item sintomatologici della LCSS, e il Total LCSS era la media di tutti i 9 item LCSS.
ASBI e Total LCSS non sono stati calcolati per un partecipante se aveva 1 o più valori mancanti per gli elementi 6 e 9, rispettivamente.
Il miglioramento massimo nei punteggi LCSS, ASBI e punteggio LCSS totale è stata la diminuzione maggiore rispetto al basale per ciascuna variabile, che era il valore non mancante più piccolo (più negativo o più piccolo positivo) tra tutte le variazioni rispetto ai valori basali per ciascuna variabile.
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Basale, giorno 21 di ciascun ciclo e 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Passaggio dal basale alla visita di follow-up a 30 giorni sui punteggi sullo stato di salute del questionario europeo sulla qualità della vita-5 dimensioni (EQ-5D)
Lasso di tempo: Basale, 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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L'EQ-5D è uno strumento di qualità della vita composto da 2 parti.
La prima parte (punteggio Health State Index) ha consentito ai partecipanti di valutare il proprio stato di salute in 5 domini di salute: mobilità, cura di sé, attività abituali, dolore/disagio e ansia/depressione utilizzando una scala da 1 a 3 (nessun problema, alcuni rispettivamente problemi e problemi estremi).
Queste combinazioni di attributi sono state convertite in un punteggio dell'indice dello stato di salute ponderato secondo un algoritmo basato sulla popolazione del Regno Unito; i valori possibili per il punteggio dell'Health State Index variavano da -0,59 (gravi problemi in tutte e 5 le dimensioni) a 1,0 (nessun problema in nessuna dimensione).
La seconda parte dell'EQ-5D era un VAS che permetteva ai partecipanti di valutare la loro attuale condizione di salute.
I possibili punteggi EQ-5D VAS variavano da 0 (peggiore stato di salute immaginabile) a 100 (miglior stato di salute immaginabile).
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Basale, 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Concentrazioni sieriche massime e minime (Cmax e Cmin) di Ramucirumab
Lasso di tempo: Prima dell'infusione e 1 ora dopo l'infusione per 4 e 8 (cicli 3 e 5 a 21 giorni/ciclo)
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Prima dell'infusione e 1 ora dopo l'infusione per 4 e 8 (cicli 3 e 5 a 21 giorni/ciclo)
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Numero di partecipanti con anticorpi anti-ramucirumab
Lasso di tempo: Basale, prima dell'infusione per la settimana 4 e 8 (cicli 3 e 5) e 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Viene riportato il numero di partecipanti che avevano anticorpi anti-farmaco (ADA) emergenti dal trattamento o dal follow-up.
I partecipanti con ADA emergente dal trattamento sono stati definiti come partecipanti che avevano un campione dal basale fino alla pre-infusione del Ciclo 5 che era un aumento di 4 volte (aumento della diluizione 2) nel titolo di immunogenicità rispetto al titolo basale, o partecipanti che sono risultati negativi al basale e positivo post-basale (con titolo ≥1:20).
I partecipanti con ADA emergente al follow-up sono stati definiti come partecipanti che avevano un campione durante 30 giorni dopo l'ultima infusione che era un aumento di 4 volte (aumento della diluizione 2) nel titolo di immunogenicità rispetto al titolo basale.
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Basale, prima dell'infusione per la settimana 4 e 8 (cicli 3 e 5) e 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Numero di partecipanti che hanno avuto eventi avversi emergenti dal trattamento (TEAE) o sono deceduti
Lasso di tempo: Prima infusione fino a 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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I dati presentati sono il numero di partecipanti che hanno manifestato almeno 1 TEAE, TEAE di grado 3, 4 o 5, evento avverso grave emergente dal trattamento (SAE), TEAE che ha portato all'interruzione del trattamento in studio (ramucirumab/placebo o docetaxel) e TEAE portando alla morte.
Gli eventi clinicamente significativi sono stati definiti come SAE emergenti dal trattamento e altri eventi avversi non gravi (AE) indipendentemente dalla causalità.
Un riepilogo degli eventi avversi gravi e di altri eventi avversi non gravi, indipendentemente dalla causalità, si trova nel modulo Eventi avversi segnalati.
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Prima infusione fino a 30 giorni dopo l'ultima infusione (fino al ciclo 38, 21 giorni/ciclo)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.
- Garon EB, Scagliotti GV, Gautschi O, Reck M, Thomas M, Iglesias Docampo L, Kalofonos H, Kim JH, Gans S, Brustugun OT, Orlov SV, Cuyun Carter G, Zimmermann AH, Oton AB, Alexandris E, Lee P, Wolff K, Stefaniak VJ, Socinski MA, Perol M. Exploratory analysis of front-line therapies in REVEL: a randomised phase 3 study of ramucirumab plus docetaxel versus docetaxel for the treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy. ESMO Open. 2020 Jan;5(1):e000567. doi: 10.1136/esmoopen-2019-000567.
- Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.
- Garon EB, Cao D, Alexandris E, John WJ, Yurasov S, Perol M. A randomized, double-blind, phase III study of Docetaxel and Ramucirumab versus Docetaxel and placebo in the treatment of stage IV non-small-cell lung cancer after disease progression after 1 previous platinum-based therapy (REVEL): treatment rationale and study design. Clin Lung Cancer. 2012 Nov;13(6):505-9. doi: 10.1016/j.cllc.2012.06.007. Epub 2012 Jul 31.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 dicembre 2010
Completamento primario (Effettivo)
1 dicembre 2013
Completamento dello studio (Effettivo)
1 agosto 2016
Date di iscrizione allo studio
Primo inviato
16 luglio 2010
Primo inviato che soddisfa i criteri di controllo qualità
22 luglio 2010
Primo Inserito (Stima)
23 luglio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 settembre 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 settembre 2019
Ultimo verificato
1 settembre 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Neoplasie polmonari
- Carcinoma, polmone non a piccole cellule
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antineoplastici
- Fattori immunologici
- Modulatori della tubulina
- Agenti antimitotici
- Modulatori della mitosi
- Docetaxel
- Ramucirumab
- Anticorpi, monoclonali
Altri numeri di identificazione dello studio
- 13852
- I4T-MC-JVBA (Altro identificatore: Eli Lilly and Company)
- 2010-021297-11 (Numero EudraCT)
- CP12-1027 (Altro identificatore: ImClone Trial Number)
- CTRI/2011/08/001942 (Identificatore di registro: Clinical Trials Registry India)
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
I dati anonimi a livello di singolo paziente saranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e di un accordo di condivisione dei dati firmato.
Periodo di condivisione IPD
I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'UE, se successiva.
I dati saranno disponibili a tempo indeterminato per la richiesta.
Criteri di accesso alla condivisione IPD
Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Carcinoma polmonare non a piccole cellule
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National Cancer Institute (NCI)ReclutamentoKita-kyushu Lung Cancer Antigen 1, umanoStati Uniti
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National Cancer Institute (NCI)NCIC Clinical Trials Group; Southwest Oncology Group; Cancer and Leukemia Group BCompletatoCarcinoma a cellule renali a cellule chiare | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti, Canada, Porto Rico
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National Cancer Institute (NCI)TerminatoCarcinoma a cellule renali a cellule chiare | Carcinoma a cellule renali metastatico | Cancro a cellule renali in stadio III AJCC v7 | Cancro a cellule renali in stadio IV AJCC v7 | Cancro a cellule renali in stadio II AJCC v7 | Stadio I Renal Cell Cancer AJCC v6 e v7Stati Uniti
Prove cliniche su Ramucirumab
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Shanghai Henlius BiotechTerminato
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Yonsei UniversityNon ancora reclutamentoTumore gastrico | Cancro della giunzione gastroesofagea (GEJ).
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.CompletatoTumore gastrico | Carcinoma polmonare non a piccole cellule | Cancro del colon-rettoCina
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Eli Lilly and CompanyParexelCompletato
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Yale UniversityRitiratoCarcinoma a cellule di transizioneStati Uniti
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Eli Lilly and CompanyCompletato
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Eli Lilly and CompanyCompletato
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Samsung Medical CenterReclutamentoTumore gastricoCorea, Repubblica di
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Eli Lilly and CompanyCompletatoCarcinoma epatocellulareStati Uniti, Canada, Belgio, Germania, Israele, Corea, Repubblica di, Spagna, Australia, Austria, Brasile, Francia, Italia, Giappone, Portogallo, Taiwan, Romania, Bulgaria, Repubblica Ceca, Finlandia, Hong Kong, Ungheria, Ol... e altro ancora
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Sidney Kimmel Comprehensive Cancer Center at Johns...National Cancer Institute (NCI); Eli Lilly and CompanyCompletatoGlioblastoma multiforme adultoStati Uniti