- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT00686959
Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer (PROCLAIM)
Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
Tutkimuksen yleiskatsaus
Tila
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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Amsterdam, Alankomaat, 1081 HV
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Breda, Alankomaat, 4818 CK
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S-Hertogenbosch, Alankomaat, 5223 GZ
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Buenos Aires, Argentiina, C1188AAF
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New South Wales
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Wollongong, New South Wales, Australia, 2500
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Tasmania
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Launceston, Tasmania, Australia, 7250
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Victoria
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Frankston, Victoria, Australia, 3199
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Antwerp, Belgia, 2020
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Edegem, Belgia, 2650
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Gent, Belgia, 9000
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Gilly, Belgia, 6060
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Haine-St.- Paul, Belgia, 7100
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Leuven, Belgia, 3000
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Namur, Belgia, 5000
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Turnhout, Belgia, 2300
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Barretos, Brasilia, 14784700
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Curitiba, Brasilia, 81520-060
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Porto Alegre, Brasilia, 90610-970
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Rio De Janeiro, Brasilia, 20231-050
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São Paulo, Brasilia, 01246000
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Alicante, Espanja, 03010
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Badalona, Espanja, 08915
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Elche, Espanja, 03202
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Hospitalet De Llobregat, Espanja, 08908
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Madrid, Espanja, 28050
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Majadahonda, Espanja, 28222
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Pamplona, Espanja, 31008
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Terrassa, Espanja, 08227
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Bangalore, Intia, 560 027
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Hyderabaad, Intia, 500024
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Jaipur, Intia, 302016
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Kolkata, Intia, 700029
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Madurai, Intia, 625020
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Mumbai, Intia, 400053
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Trivandrum, Intia, 695011
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Dublin, Irlanti
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Alberta
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Edmonton, Alberta, Kanada, T6G 1Z2
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Ontario
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London, Ontario, Kanada, N6A 4L6
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Newmarket, Ontario, Kanada, L3Y2P9
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Toronto, Ontario, Kanada, M5G 2M9
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Quebec
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Montreal, Quebec, Kanada, H3G 1A4
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Beijing, Kiina, 100021
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Guang Zhou, Kiina, 510060
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Jinan, Kiina
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Shanghai, Kiina, 200030
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Sichuan, Kiina, 610041
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Wu Han, Kiina, 430030
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Incheon, Korean tasavalta, 405-760
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Seoul, Korean tasavalta, 139-706
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Suwon-City, Korean tasavalta, 442-723
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Athens, Kreikka, 18537
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Patras, Kreikka, 26500
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Lisbon, Portugali, 1649-035
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Santa Maria Da Feira, Portugali, 4520-211
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Vila Franca De Xira, Portugali, 4434-502
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Bayonne, Ranska, 64100
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Lille, Ranska, 59020
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Paris, Ranska, 75475
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Pierre Benite, Ranska, 69495
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Erlangen, Saksa, 91054
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Frankfurt, Saksa, 60596
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Hannover, Saksa, 30625
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Hemer, Saksa, 58675
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Immenhausen, Saksa, 34376
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Köln, Saksa, 51109
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Mainz, Saksa, 55131
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Mannheim, Saksa, 68167
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Oldenburg, Saksa, 26121
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Rheine, Saksa, 48431
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Ulm, Saksa, 89081
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Kaohsiung, Taiwan, 813
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Kuei Shan Hsiang, Taiwan, 33305
- 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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Taichung, Taiwan, 40705
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Taipei, Taiwan, 100
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Fatih, Turkki, 34098
- 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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Gaziantep, Turkki, 27310
- 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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Izmir, Turkki, 35100
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Melikgazi, Turkki, 38039
- 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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Umuttepe, Turkki, 41380
- 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, Yhdistynyt kuningaskunta, M20 4BX
- 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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Birmingham
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Edgbaston, Birmingham, Yhdistynyt kuningaskunta, B15 2TH
- 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
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London, Greater London, Yhdistynyt kuningaskunta, 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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Scotland
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Edinburgh, Scotland, Yhdistynyt kuningaskunta, EH4 2XU
- 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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Alabama
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Birmingham, Alabama, Yhdysvallat, 35249
- 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
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Scottsdale, Arizona, Yhdysvallat, 85259
- 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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Tucson, Arizona, Yhdysvallat, 85704
- 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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Arkansas
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Fayetteville, Arkansas, Yhdysvallat, 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.
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California
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Duarte, California, Yhdysvallat, 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.
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Fountain Valley, California, Yhdysvallat, 92708
- 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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La Jolla, California, Yhdysvallat, 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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Connecticut
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New Haven, Connecticut, Yhdysvallat, 06520
- 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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Florida
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Hollywood, Florida, Yhdysvallat, 33021
- 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.
-
Tampa, Florida, Yhdysvallat, 33612
- 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.
-
West Palm Beach, Florida, Yhdysvallat, 33401
- 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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Georgia
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Athens, Georgia, Yhdysvallat, 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.
-
Marietta, Georgia, Yhdysvallat, 30060
- 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.
-
Thomasville, Georgia, Yhdysvallat, 31792
- 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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Illinois
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Chicago, Illinois, Yhdysvallat, 60637
- 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.
-
Quincy, Illinois, Yhdysvallat, 62301
- 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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Indiana
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Evansville, Indiana, Yhdysvallat, 47713
- 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.
-
Indianapolis, Indiana, Yhdysvallat, 46237
- 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 Albany, Indiana, Yhdysvallat, 47150
- 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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Kansas
-
Westwood, Kansas, Yhdysvallat, 66205
- 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, Yhdysvallat, 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.
-
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40402
- 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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Maryland
-
Columbia, Maryland, Yhdysvallat, 21044
- 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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Massachusetts
-
Fairhaven, Massachusetts, Yhdysvallat, 02719
- 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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Michigan
-
Ann Arbor, Michigan, Yhdysvallat, 48106
- 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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Minnesota
-
Minneapolis, Minnesota, Yhdysvallat, 55455
- 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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Missouri
-
Kansas City, Missouri, Yhdysvallat, 64132
- 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.
-
St Louis, Missouri, Yhdysvallat, 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.
-
-
New York
-
Bronx, New York, Yhdysvallat, 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.
-
New York, New York, Yhdysvallat, 10065
- 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 Dakota
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Fargo, North Dakota, Yhdysvallat, 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.
-
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Ohio
-
Cincinnati, Ohio, Yhdysvallat, 45242
- 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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South Carolina
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Charleston, South Carolina, Yhdysvallat, 29425
- 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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Tennessee
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Chattanooga, Tennessee, Yhdysvallat, 37404
- 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, Yhdysvallat, 38119
- 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.
-
Nashville, Tennessee, Yhdysvallat, 37203
- 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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Texas
-
Bedford, Texas, Yhdysvallat, 76022
- 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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Dallas, Texas, Yhdysvallat, 75246
- 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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Longview, Texas, Yhdysvallat, 75601
- 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.
-
Odessa, Texas, Yhdysvallat, 79761
- 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.
-
San Marcos, Texas, Yhdysvallat, 78666
- 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.
-
Sherman, Texas, Yhdysvallat, 75090
- 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.
-
Sugar Land, Texas, Yhdysvallat, 77479
- 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.
-
The Woodlands, Texas, Yhdysvallat, 77380
- 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 Falls, Texas, Yhdysvallat, 76310
- 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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Vermont
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Burlington, Vermont, Yhdysvallat, 05405
- 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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Washington
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Spokane, Washington, Yhdysvallat, 99220
- 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.
-
Vancouver, Washington, Yhdysvallat, 98684
- 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 Virginia
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Morgantown, West Virginia, Yhdysvallat, 26506
- 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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Wisconsin
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Madison, Wisconsin, Yhdysvallat, 53792
- 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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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
- Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
- Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
- Participants must be 18 years of age or older
- Participants must have lost no more than 10% of their body weight in the previous 3 months
- Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception
- Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory
- Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.
Exclusion Criteria:
- Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
- Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
- Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
- Participants who have received other investigational drugs within the last 30 days
- Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
- Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors
- Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment.
- Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation
- Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: Arm A: Pemetrexed + Cisplatin and TRT
Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles |
infusion over 10 minutes
Muut nimet:
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
|
Active Comparator: Arm B: Etoposide + Cisplatin and TRT
Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22 |
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
administered per local practice guidelines over a minimum of 30 minutes
administered over 6-10 minutes infusion per local practice guidelines
administered as a 3-hour infusion
administered per local practice guidelines over 30 minutes
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Overall Survival
Aikaikkuna: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
|
Overall survival (OS) time is from baseline to the date of death from any cause.
For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date.
OS was summarized using Kaplan-Meier estimates.
|
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Progression-free Survival (PFS)
Aikaikkuna: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
|
Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause.
For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments.
For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy.
PFS time was summarized using Kaplan-Meier estimates.
|
Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
|
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Aikaikkuna: Baseline to Measured Progressive Disease (Up to 7 Months)
|
Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines.
CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm).
PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.
Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
|
Baseline to Measured Progressive Disease (Up to 7 Months)
|
Survival Rates at 1, 2, and 3 Years
Aikaikkuna: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
|
The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
|
Baseline to Date of Death from Any Cause (Up to 71.4 Months)
|
First Site of Disease Failure in Terms of Relapse
Aikaikkuna: Baseline to Relapse (Up to 66.6 Months)
|
The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented.
Results were summarized using Kaplan-Meier estimates.
Some participants relapsed in more than 1 location/site and appear in more than a single category.
|
Baseline to Relapse (Up to 66.6 Months)
|
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
Aikaikkuna: Baseline through 30 Days Post Study
|
Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids.
Participants rated swallowing over the previous 24 hours.
The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100.
No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.
|
Baseline through 30 Days Post Study
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Adverse Events: The Number of Deaths Per Treatment Group
Aikaikkuna: Baseline through 30 Days Post Study
|
The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented.
In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented.
For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented.
A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
|
Baseline through 30 Days Post Study
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.
- Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
- Hengityselinten sairaudet
- Neoplasmat
- Keuhkosairaudet
- Neoplasmat sivustoittain
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Keuhkojen kasvaimet
- Karsinooma, ei-pienisoluinen keuhko
- Farmakologisen vaikutuksen molekyylimekanismit
- Nukleiinihapposynteesin estäjät
- Entsyymin estäjät
- Antineoplastiset aineet
- Tubuliinimodulaattorit
- Antimitoottiset aineet
- Mitoosin modulaattorit
- Antineoplastiset aineet, fytogeeniset
- Topoisomeraasi II:n estäjät
- Topoisomeraasin estäjät
- Foolihappoantagonistit
- Karboplatiini
- Etoposidi
- Paklitakseli
- Vinorelbiini
- Pemetreksedi
Muut tutkimustunnusnumerot
- 11514
- H3E-MC-JMIG (Muu tunniste: Eli Lilly and Company)
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Ei-pienisoluinen keuhkosyöpä
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Jonsson Comprehensive Cancer CenterEli Lilly and Company; Genentech, Inc.RekrytointiMetastaattinen keuhkojen ei-pienisolusyöpä | Tulenkestävä keuhkojen ei-pienisolusyöpä | Stage IV Lung Cancer American Joint Committee on Cancer (AJCC) v8 | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8Yhdysvallat
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Eben RosenthalRekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Keuhkokarsinooma | Metastaattinen pahanlaatuinen kasvain keuhkoissaYhdysvallat
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University of Southern CaliforniaNational Cancer Institute (NCI); Genentech, Inc.RekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | Vaiheen III keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Vaiheen II keuhkosyöpä AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Vaiheen IIB keuhkosyöpä AJCC v8 | Vaiheen IIIA keuhkosyöpä AJCC v8 | Vaiheen IIIB... ja muut ehdotYhdysvallat
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Wake Forest University Health SciencesNational Cancer Institute (NCI)LopetettuPienisoluinen keuhkosyöpä | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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Emory UniversityNational Cancer Institute (NCI)RekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; California Institute... ja muut yhteistyökumppanitRekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Keuhkojen ei-pienisolukarsinooma | IV vaiheen keuhkosyöpä AJCC v8Yhdysvallat
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Aktiivinen, ei rekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | Vaiheen III keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Vaiheen II keuhkosyöpä AJCC v8 | Stage IIA Lung Cancer AJCC v8 | Vaiheen IIB keuhkosyöpä AJCC v8 | Vaiheen IIIA keuhkosyöpä AJCC v8 | Vaiheen IIIB keuhkosyöpä AJCC v8 | I vaiheen... ja muut ehdotYhdysvallat
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M.D. Anderson Cancer CenterPeruutettuMetastaattinen keuhkojen ei-pienisolusyöpä | Stage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8
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AstraZenecaValmisEdistynyt kastraattiresistentti eturauhassyöpä CRPC | Squamous Non-Small Cell Lung Cancer sqNSCLC | Kolminkertainen negatiivinen rintasyöpä TNBCEspanja, Kanada, Yhdysvallat, Yhdistynyt kuningaskunta
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Ohio State University Comprehensive Cancer CenterRekrytointiStage IVA Lung Cancer AJCC v8 | Vaihe IVB keuhkosyöpä AJCC v8 | IV vaiheen keuhkosyöpä AJCC v8 | Keuhkojen ei-squamous ei-pienisolusyöpä | Vaiheen IIIB keuhkosyöpä AJCC v8Yhdysvallat
Kliiniset tutkimukset Pemetrexed
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IO BiotechMerck Sharp & Dohme LLCValmisNSCLCYhdistynyt kuningaskunta, Saksa, Alankomaat, Espanja
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Innate PharmaRekrytointiEi-pienisoluinen keuhkosyöpäRanska, Yhdysvallat, Kreikka, Unkari, Puola
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Pharmacyclics LLC.LopetettuEi-pienisoluinen keuhkosyöpäYhdysvallat
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Avistone Biotechnology Co., Ltd.Ei vielä rekrytointia
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Shanghai Hengrui Pharmaceutical Co., Ltd.Rekrytointi
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Bio-Thera SolutionsEi vielä rekrytointiaKarsinooma, ei-pienisoluinen keuhko
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Julia K. Rotow, MDInivataAktiivinen, ei rekrytointiMetastaattinen ei-pienisoluinen keuhkosyöpä | NSCLC vaihe IVYhdysvallat
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Innovent Biologics (Suzhou) Co. Ltd.ValmisSyöpä, kiinteä kasvainKiina