Abemaciclib (LY2835219) -tutkimus osallistujilla, joilla on aiemmin hoidettu KRAS-mutaation aiheuttama keuhkosyöpä (JUNIPER)
maanantai 19. tammikuuta 2026 päivittänyt: Eli Lilly and Company
JUNIPER: Satunnaistettu vaiheen 3 tutkimus Abemaciclib Plusin parhaasta tukihoidosta verrattuna Erlotinib Plusin parhaaseen tukihoitoon potilailla, joilla on vaiheen IV NSCLC, joilla on havaittavissa oleva KRAS-mutaatio ja jotka ovat edenneet platinapohjaisen kemoterapian jälkeen
Tämän tutkimuksen päätarkoituksena on arvioida, kuinka turvallinen ja tehokas tutkimuslääke, joka tunnetaan nimellä abemaciclib, on potilailla, joilla on keuhkosyöpä.
Tutkimuksen yleiskatsaus
Tila
Aktiivinen, ei rekrytointi
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
453
Vaihe
- Vaihe 3
Laajennettu käyttöoikeus
Hyväksytty myytävänä yleisölle.
Katso laajennettu käyttöoikeustietue.
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Berazategui, Argentiina, B1884BBF
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Ciudad Autonoma Buenos Aires, Argentiina, 1093
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Ciudad Autonoma Buenos Aires, Argentiina, 1025
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Ciudad Autonoma Buenos Aires, Argentiina, C1181AAX
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Rosario, Argentiina, 2000
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Rosario, Argentiina, S2000DSV
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Viedma, Argentiina, 8500
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Ijuí, Brasilia, 98700 000
- Associacao Hospital de Caridade Ijui
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Lajeados, Brasilia, 95900-000
- Hospital Bruno Born
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Porto Alegre, Brasilia, 90610-970
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Rio de Janeiro, Brasilia, 20231-050
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Salvador, Brasilia, 41253-190
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Sao Jose Rio Preto, Brasilia, 15090-000
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São Paulo, Brasilia, 01246000
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São Paulo, Brasilia, 01509-010
- Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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A Coruña, Espanja, 15006
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Barcelona, Espanja, 08003
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L'Hospitalet de Llobregat, Espanja, 08907
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Madrid, Espanja, 28041
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Madrid, Espanja, 28040
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Madrid, Espanja, 28050
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Málaga, Espanja, 29010
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Seville, Espanja, 41013
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Valencia, Espanja, 46026
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Goyang-si, Etelä -Korea, 10408
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Incheon, Etelä -Korea, 21565
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Seoul, Etelä -Korea, 03722
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Seoul, Etelä -Korea, 05505
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Seoul, Etelä -Korea, 06351
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Seoul, Etelä -Korea, 06591
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Seowon-Gu, Etelä -Korea, 28644
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Suwon, Etelä -Korea, 16247
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Ulsan, Etelä -Korea, 44033
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Holon, Israel, 5822012
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Jerusalem, Israel, 9112001
- Hadassah Medical Center - Ein Karem
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Kfar Saba, Israel, 4428164
- Meir Medical Center
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Petah Tikva, Israel, 4941492
- 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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Tel Litwinsky, Israel, 5265601
- Sheba medical center
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Catania, Italia, 95125
- 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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Genova, Italia, 16132
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Livorno, Italia, 57124
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Parma, Italia, 43100
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Rome, Italia, 00152
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Graz, Itävalta, 8036
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Linz, Itävalta, 4020
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Linz, Itävalta, 4021
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Salzburg, Itävalta, 5020
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Amagasaki, Japani, 660-0892
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Asahikawa, Japani, 070-8644
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Bunkyō City, Japani, 113-8431
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Bunkyō City, Japani, 113-8677
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Fukuoka, Japani, 811-1395
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Habikino, Japani, 583-8588
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Hirakata, Japani, 573-1191
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Hiroshima, Japani, 734-8551
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Hyōgo, Japani, 6608550
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Kanazawa, Japani, 920-8641
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Kashiwa, Japani, 277 8577
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Kishiwada, Japani, 596-8501
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Kitaadachi-Gun, Japani, 362-0806
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Kobe, Japani, 650-0047
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Kurashiki, Japani, 710-8602
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Kōtoku, Japani, 135-8550
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Matsuyama, Japani, 791-0280
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Nagasaki, Japani, 852-8501
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Nagoya, Japani, 464-8681
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Nagoya, Japani, 466-8560
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Natori, Japani, 981-1293
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Okayama, Japani, 700-8558
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Osaka, Japani, 545-8586
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Osaka, Japani, 534-0021
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Osaka, Japani, 537-8511
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Sakai, Japani, 5918555
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Sayama, Japani, 589-8511
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Sendai, Japani, 980-0873
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Shinjuku-ku, Japani, 160-0023
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Sunto-Gun, Japani, 411-8777
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Ube, Japani, 755-0241
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Utsunomiya, Japani, 320-0834
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Wakayama, Japani, 641-8510
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Yokohama, Japani, 236-0004
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Yonago, Japani, 683-0826
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Yufu-shi, Japani, 8795593
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Calgary, Kanada, T2N 4N2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Edmonton, Kanada, T6G 1Z2
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Montreal, Kanada, H2L 4M1
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Toronto, Kanada, M4N 3M5
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Vancouver, Kanada, V5Z 4E6
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Winnipeg, Kanada, R3A 1M3
- For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
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Beijing, Kiina, 100071
- 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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Beijing, Kiina, 100021
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Beijing, Kiina, 100730
- 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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Changchun, Kiina, 130012
- 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.
-
Changzhou, Kiina, 213000
- 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.
-
Chengdu, Kiina, 610041
- 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.
-
Haikou, Kiina, 570311
- 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.
-
Hangzhou, Kiina, 310022
- 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.
-
Hefei, Kiina, 230001
- 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.
-
Nanning, Kiina, 530021
- 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.
-
Shanghai, Kiina, 200030
- 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.
-
Shenyang, Kiina, 100042
- 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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Athens, Kreikka, 11527
- 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.
-
Athens, Kreikka, 11522
- 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.
-
Athens, Kreikka, 18537
- 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.
-
Heraklion, Kreikka, 71110
- 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.
-
Pátrai, Kreikka, 26504
- 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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San Juan, Puerto Rico, 00921-3201
- VA Caribbean Healthcare System
-
-
-
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Gdansk, Puola, 80-219
- 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.
-
Lodz, Puola, 90-242
- 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.
-
Olsztyn, Puola, 10-357
- 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.
-
Radom, Puola, 26-617
- 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.
-
Szczecin, Puola, 70-891
- 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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Bron, Ranska, 69677
- 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.
-
Dijon, Ranska, 21034
- 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
-
Grenoble, Ranska, 38043
- 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.
-
Lille, Ranska, 59037
- 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.
-
Marseille, Ranska, 13015
- 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.
-
Poitiers, Ranska, 86021
- 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.
-
Rennes, Ranska, 35033
- 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-Brieuc, Ranska, 22027
- 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-Priest-en-Jarez, Ranska, 42270
- 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.
-
Toulouse, Ranska, 31059
- 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.
-
Vantoux, Ranska, 57070
- 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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Baia Mare, Romania, 430031
- 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.
-
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.
-
Cluj-Napoca, Romania, 400015
- 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.
-
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.
-
Craiova, Romania, 200347
- 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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-
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Berlin, Saksa, 14165
- 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.
-
Gera, Saksa, 07548
- 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.
-
Großhansdorf, Saksa, 22927
- 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.
-
Hamburg, Saksa, 21075
- 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.
-
Hanover, Saksa, 30459
- 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.
-
Heidelberg, Saksa, 69126
- 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.
-
Immenhausen, Saksa, 34376
- 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.
-
Nuremberg, Saksa, 90419
- 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.
-
Regensburg, Saksa, 93053
- 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.
-
Rosenheim, Saksa, 83022
- 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.
-
Tübingen, Saksa, 72076
- 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.
-
Ulm, Saksa, 89081
- 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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Chiayi City, Taiwan, 613
- 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.
-
Kaohsiung City, Taiwan, 83301
- 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.
-
Kaohsiung City, Taiwan, 82445
- 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.
-
Taichung, Taiwan, 40447
- 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.
-
Taichung, Taiwan, 404
- 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.
-
Tainan, Taiwan, 70403
- 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.
-
Taipei, Taiwan, 10449
- 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.
-
Taipei, Taiwan, 11217
- 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.
-
Taipei, Taiwan, 10002
- 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.
-
Zhonghe, Taiwan, 235
- 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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Ankara, Turkki (Türkiye), 06100
- 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.
-
Ankara, Turkki (Türkiye), 06490
- 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.
-
Antalya, Turkki (Türkiye), 07059
- 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.
-
Edirne, Turkki (Türkiye), 22030
- 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.
-
Istanbul, Turkki (Türkiye), 34020
- 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.
-
Istanbul, Turkki (Türkiye), 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.
-
Istanbul, Turkki (Türkiye), 34890
- 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.
-
Izmir, Turkki (Türkiye), 35100
- 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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Dnipropetrovsk, Ukraina, 49102
- 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.
-
Kharkiv, Ukraina, 61070
- 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.
-
Kryvyi Rih, Ukraina, 50048
- 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.
-
Kyiv, Ukraina, 04107
- 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.
-
Lutsk, Ukraina, 63000
- 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.
-
Poltava, Ukraina, 36011
- 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.
-
Sumy, Ukraina, 40005
- 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.
-
Uzhhorod, Ukraina, 88000
- 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.
-
Vinnitsa, Ukraina, 21029
- 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.
-
-
-
-
-
Arkhangelsk, Venäjä, 163045
- Arkhangelsk Regional Clinical Oncology Dispensary
-
Chelyabinsk, Venäjä, 454048
- Private clinic "Evimed"
-
Krasnodar, Venäjä, 350086
- Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
-
Kursk, Venäjä, 305035
- 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.
-
Moscow, Venäjä, 115478
- Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
-
Saint Petersburg, Venäjä, 198255
- Saint-Petersburg City Clinical Oncology Dispensary
-
Saint Petersburg, Venäjä, 197758
- St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
-
Ufa, Venäjä, 450054
- Republic clinical oncology dispensary of MoH of Bashkortostan Republic
-
Volzhskiy, Venäjä, 404130
- Volgograd Regional Clinical Oncology Dispensary
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, Yhdysvallat, 72703
- Highlands Oncology Group
-
Jonesboro, Arkansas, Yhdysvallat, 72401
- St. Bernards Medical Center
-
-
California
-
Duarte, California, Yhdysvallat, 91010
- City of Hope National Medical Center
-
La Jolla, California, Yhdysvallat, 92037
- University of California - San Diego
-
Loma Linda, California, Yhdysvallat, 92350
- Loma Linda University School of Medicine
-
Los Angeles, California, Yhdysvallat, 90024
- SMO TRIO -Translational Research
-
Los Angeles, California, Yhdysvallat, 90024
- CBCC Global Research, Inc.
-
Los Angeles, California, Yhdysvallat, 90024
- Central Coast Medical Oncology Corporation
-
Los Angeles, California, Yhdysvallat, 90024
- Fort Wayne Oncology & Hematology
-
Los Angeles, California, Yhdysvallat, 90024
- St. Joseph Heritage Medical Group
-
Los Angeles, California, Yhdysvallat, 90024
- UCLA Department of Medicine-Hematology/Oncology
-
Los Angeles, California, Yhdysvallat, 90095
- Cancer Care Associates Medical Group
-
Sacramento, California, Yhdysvallat, 95816
- Dignity Health Care Institute
-
-
Colorado
-
Englewood, Colorado, Yhdysvallat, 80112
- SMO Catholic Health Initiatives
-
Englewood, Colorado, Yhdysvallat, 80112
- Alegent Immanuel Cancer Center
-
Englewood, Colorado, Yhdysvallat, 80112
- Jewish Hospital
-
Englewood, Colorado, Yhdysvallat, 80112
- Oncology Hematology West
-
Englewood, Colorado, Yhdysvallat, 80112
- St Joseph Cancer Center
-
Englewood, Colorado, Yhdysvallat, 80112
- St. Francis Medical Center
-
-
Delaware
-
Newark, Delaware, Yhdysvallat, 19713
- Medical Oncology Hematology Consultants
-
-
Florida
-
Boca Raton, Florida, Yhdysvallat, 33486
- Boca Raton Regional Hospital
-
Daytona Beach, Florida, Yhdysvallat, 32114
- Halifax Medical Center
-
Pembroke Pines, Florida, Yhdysvallat, 33028
- Memorial Cancer Institute
-
Tampa, Florida, Yhdysvallat, 33612-9497
- H Lee Moffitt Cancer Center
-
-
Georgia
-
Athens, Georgia, Yhdysvallat, 30607
- University Cancer & Blood Center, LLC
-
-
Illinois
-
Harvey, Illinois, Yhdysvallat, 60426
- Ingalls Memorial Hospital
-
-
Indiana
-
Indianapolis, Indiana, Yhdysvallat, 46202
- Indiana University School of Medicine
-
-
Iowa
-
Iowa City, Iowa, Yhdysvallat, 52242
- University of Iowa
-
-
Kansas
-
Wichita, Kansas, Yhdysvallat, 67214
- Cancer Center of Kansas, P.A.
-
-
Kentucky
-
Lexington, Kentucky, Yhdysvallat, 40503
- Central Baptist Hospital
-
Louisville, Kentucky, Yhdysvallat, 40202
- University of Louisville
-
-
Maryland
-
Bethesda, Maryland, Yhdysvallat, 20889
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Framingham, Massachusetts, Yhdysvallat, 01701
- Metro-West and Greater Boston CNS Research
-
-
Michigan
-
Detroit, Michigan, Yhdysvallat, 48201
- Karmanos Cancer Institute
-
-
Missouri
-
Springfield, Missouri, Yhdysvallat, 65807
- Mercy Medical Research Institute
-
-
Montana
-
Billings, Montana, Yhdysvallat, 59101
- Billings Clinic Research Center
-
-
New Hampshire
-
Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth Hitchcock Medical Center
-
-
New York
-
Johnson City, New York, Yhdysvallat, 13790
- Broome Oncology
-
New York, New York, Yhdysvallat, 10065
- Weill Cornell Medical College
-
-
Ohio
-
Cincinnati, Ohio, Yhdysvallat, 45242
- Oncology Hematology Care Inc
-
-
Oklahoma
-
Tulsa, Oklahoma, Yhdysvallat, 74146
- Oklahoma Cancer Specialists & Research Institute, LLC
-
-
Oregon
-
Portland, Oregon, Yhdysvallat, 97213
- Providence Cancer Center Oncology Hematology Care
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Yhdysvallat, 15213
- UPMC Hillman Cancer Center
-
-
South Carolina
-
Charleston, South Carolina, Yhdysvallat, 29401
- Roper St. Francis Healthcare
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-
Tennessee
-
Chattanooga, Tennessee, Yhdysvallat, 37404
- Chattanooga Oncology Hematology Associates
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Nashville, Tennessee, Yhdysvallat, 37203
- Tennessee Oncology PLLC
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Nashville, Tennessee, Yhdysvallat, 37203
- Chattanooga Oncology Hematology Associates
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Texas
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Dallas, Texas, Yhdysvallat, 75230
- Mary Crowley Cancer Research Center
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Utah
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Salt Lake City, Utah, Yhdysvallat, 84106
- Utah Cancer Specialists
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Vermont
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Burlington, Vermont, Yhdysvallat, 05401
- University of Vermont Medical Center
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Virginia
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Richmond, Virginia, Yhdysvallat, 23298
- Virginia Commonwealth University
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Washington
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Kennewick, Washington, Yhdysvallat, 99336
- Kadlec Clinical Hematology & Oncology
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Seattle, Washington, Yhdysvallat, 98104
- Swedish Medical Center
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Valley, Washington, Yhdysvallat, 99216
- Cancer Care Northwest
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Olet vahvistanut vaiheen IV ei-pienisoluisen keuhkosyövän (NSCLC) diagnoosin American Joint Committee on Cancer Staging Handbookin mukaan.
- Tutkimuskeskuksen laboratoriossa tehdyllä tutkimusmäärityksellä todettiin havaittavissa olevia mutaatioita kirsten rotan sarkooman (KRAS) onkogeenin kodoneissa 12 tai 13. KRAS-positiivinen mutaatiotulos kasvainkudoksesta peräisin olevan KRAS-onkogeenin kodoneissa 12 tai 13 paikallista laboratoriota kohden sallitaan enintään 10 %:lla satunnaistetuista osallistujista.
- olet edennyt platinapohjaisen kemoterapian jälkeen (ylläpitohoidolla tai ilman) JA olet saanut yhden lisähoidon, joka voi sisältää immuunivasteen estäjän tai muun syövän vastaisen hoidon edenneen ja/tai metastaattisen taudin hoitoon TAI lääkäri arvioi, ettei se ole kelvollinen jatkohoitoon tavallinen toisen linjan kemoterapia. Osallistujat, jotka ovat edenneet platinapohjaisen kemoterapian ja immuunivasteen estäjän (immunoterapian) jälkeen esim. pembrolitsumabi tai nivolumabi yksinään tai yhdessä muiden aineiden kanssa ovat kelvollisia.
- sinulla on mitattavissa oleva sairaus kiinteiden kasvainten vasteen arviointikriteerien (RECIST 1.1) mukaisesti.
- Suorituskykytila (PS) on 0–1 ECOG-asteikolla.
- Kaikki aiemmat syövän hoidot (mukaan lukien kemoterapia, sädehoito, immunoterapia ja tutkimushoito) on keskeytetty vähintään 21 päiväksi myelosuppressiivisten aineiden tai 14 päivän ajan muiden kuin myelosuppressiivisten aineiden osalta ennen tutkimuslääkkeen saamista.
Poissulkemiskriteerit:
- ovat saaneet hoitoa lääkkeellä, joka ei ole saanut viranomaishyväksyntää millekään indikaatiolle 14 tai 21 päivän kuluessa ei-myelosuppressiivisen tai myelosuppressiivisen aineen tutkimuslääkkeen aloitusannoksesta.
- Sinulla on ollut jokin seuraavista tiloista: presynkooppi tai pyörtyminen, johtuen joko selittämättömästä tai kardiovaskulaarisesta etiologiasta, kammiorytmia (mukaan lukien, mutta ei rajoittuen, kammiotakykardia ja kammiovärinä) tai äkillinen sydämenpysähdys.
- Sinulla on epävakaa keskushermoston (CNS) etäpesäke. Keskushermoston etäpesäkkeiden tai stabiilien keskushermoston etäpesäkkeiden historia on sallittu (ei enää vaadi aktiivista hoitoa, kuten steroidilääkkeitä). Osallistujille, joilla on ollut keskushermoston etäpesäkkeitä, on tehtävä aivoskannaus (esimerkiksi magneettikuvaus [MRI]) 28 päivän kuluessa satunnaistamisesta vakauden dokumentoimiseksi, vaikka oireissa ei olisikaan tapahtunut muutoksia.
- ovat aiemmin saaneet päätökseen tai vetäytyneet tästä tutkimuksesta tai mistä tahansa muusta tutkimuksesta, jossa tutkitaan sykliiniriippuvaisen kinaasi 4:n (CDK4) ja sykliiniriippuvaisen kinaasi 6:n (CDK6) estäjiä, tai ovat saaneet hoitoa aiemmilla CDK4- ja CDK6-estäjillä.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
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 |
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Kokeellinen: Abemaciclib
200 milligrammaa (mg) abemasiklibiä annettuna suun kautta 12 tunnin välein plus paras tukihoito (BSC) päivinä 1–28 (28 päivän jaksot).
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Annostetaan suun kautta
Muut nimet:
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Active Comparator: Erlotinibi
150 mg erlotinibia annettuna suun kautta 24 tunnin välein plus BSC päivinä 1–28 (28 päivän jaksot).
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Annostetaan suun kautta
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Kokonaiseloonjääminen (OS)
Aikaikkuna: Satunnaistamispäivästä mistä tahansa syystä kuolinpäivään (jopa 32 kuukautta)
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Käyttöjärjestelmä määritellään satunnaistamispäivästä mistä tahansa syystä johtuvaan kuolemaan.
Jokaisen osallistujan osalta, jonka ei tiedetä kuolleen tietojen sisällyttämisen rajapäivänä kokonaiseloonjäämisanalyysiin, käyttöjärjestelmän aika sensuroitiin viimeisenä päivänä, jonka osallistujan tiedettiin olevan elossa.
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Satunnaistamispäivästä mistä tahansa syystä kuolinpäivään (jopa 32 kuukautta)
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Prosenttiosuus osallistujista, joilla on täydellinen vastaus (CR) tai osittainen vastaus (PR) (objektiivinen vastausprosentti [ORR])
Aikaikkuna: Satunnaistamispäivästä tavoitteelliseen etenemiseen (jopa 32 kuukautta)
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ORR oli niiden osallistujien prosenttiosuus, jotka saavuttivat parhaan kokonaisvasteen (BOR) täydellisestä vasteesta (CR) tai osittaisesta vasteesta (PR) kiinteiden kasvainten vasteen arviointikriteerien (RECIST) v1.1 mukaisesti.
CR määritellään kaikkien kohde- ja ei-kohdeleesioiden katoamiseksi eikä uusien leesioiden ilmaantumista.
PR määritellään vähintään 30 %:n pienenemiseksi kohdeleesioiden pisimpien halkaisijoiden (LD) summassa (vertailuna LD-perussumma), ei-kohdeleesioiden eteneminen ja uusien leesioiden ilmaantuminen.
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Satunnaistamispäivästä tavoitteelliseen etenemiseen (jopa 32 kuukautta)
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Progression Free Survival (PFS)
Aikaikkuna: Satunnaistamispäivästä taudin etenemiseen tai mistä tahansa syystä johtuvaan kuolemaan (jopa 32 kuukautta)
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PFS määritellään satunnaistamisen päivämäärästä ensimmäiseen sairauden etenemisen todisteeseen RECIST v1.1:n mukaisesti tai kuolemasta mistä tahansa syystä.
Progressiivinen sairaus (PD) oli vähintään 20 %:n lisäys kohteena olevien leesioiden halkaisijoiden summassa, jolloin viite oli tutkimuksen pienin summa ja vähintään 5 mm:n absoluuttinen lisäys, tai ei-kohdevaurioiden yksiselitteinen eteneminen, tai 1 tai useampi uusi vaurio.
Jos osallistujalla ei ole täydellistä perussairausarviota, PFS-aika sensuroitiin ensimmäisen annoksen ottopäivänä riippumatta siitä, onko osallistujalla havaittu objektiivisesti määritettyä taudin etenemistä tai kuolemaa.
Jos osallistujan ei tiedetty kuolleen tai hänen objektiivisesti etenevän analyysin tietojen sisällyttämisen katkaisupäivänä, PFS-aika sensuroitiin viimeisenä riittävänä kasvaimen arviointipäivänä.
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Satunnaistamispäivästä taudin etenemiseen tai mistä tahansa syystä johtuvaan kuolemaan (jopa 32 kuukautta)
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Muutos lähtötasosta MD Andersonin oireiden inventaario-keuhkosyöpä (MDASI-LC) -pisteissä
Aikaikkuna: Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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MDASI-LC sisälsi 22 kohdetta + 3 muuta koekohtaista kohdetta, mikä johti 6 kerättyyn ja raportoituun yksittäisen konstruktion pistemäärään, mukaan lukien ydinoireet (13 kohtaa), häiriö (6 kohta), keuhkosyöpä (3 kohta) ja tutkimuskohtaiset yksittäiset tulokset päänsärkyyn, ripuliin ja ihottumaan.
2-konstruktion yhdistelmäydin + keuhkosyövän oire (16 kohta) laskettiin.
Tiedot kaikista seitsemästä pisteestä kerättiin 11 pisteen numeerisen luokitusasteikon avulla, joka oli ankkuroitu 0:aan (ei läsnä tai ei häiritse) ja 10:een (niin huono kuin voit kuvitella tai häiriintyi täysin).
Mittausalue oli 10 (maksimipistemäärä-minimipistemäärä).
Mixed Model Repeated Measure (MMRM) -regressio hoidon, käynnin, hoito*käynnin ja ennustetun lähtötason pistemäärän yhteismuuttujilla tarkoittaa ryhmien välisiä pienimmän neliösumman (LS) eroja lähtötasosta.
Ryhmätason negatiivinen muutos lähtötilanteesta osoitti ryhmän paranemista.
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Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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Farmakokinetiikka (PK): Pitoisuuden ja aikakäyrän alla oleva pinta-ala 1 annosvälin aikana vakaassa tilassa
Aikaikkuna: Päivä 1 syklistä 1 - sykliin 3 (28 päivän syklit)
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PK määräytyy plasmakonsentraatio-aikakäyrän alla olevalla pinta-alalla 1 annosvälin aikana vakaassa tilassa
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Päivä 1 syklistä 1 - sykliin 3 (28 päivän syklit)
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Muutos lähtötasosta eurooppalaisessa elämänlaadussa - 5 ulottuvuutta - 5 tasoa (EQ-5D-5L)
Aikaikkuna: Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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Hyvästä huonoon jatkumossa 1-5 on viisi vastetasoa, jotka vastaavat ei mitään, lievä, kohtalainen, vakava ja äärimmäinen/ei pysty.
EuroQolin kehittämää ylikulkumenetelmää käytettiin muuntamaan EQ-5D-5L käyttämällä Yhdistyneen kuningaskunnan painoja, terveysmittoja (liikkuvuus, itsehoito, tavanomaiset toiminnot, kipu/epämukavuus ja ahdistus/masennus) yhdeksi indeksiksi. arvo; mittoja ei pisteytetä erikseen.
Indeksi on merkitty puuttuvaksi, kun ≥1 mittaa puuttuu.
Reaktiomallien indeksipisteet ankkuroitiin täysin terveydelle kuolleille negatiivisilla arvoilla vastemalleille/terveyden tiloille, joita pidettiin kuolemaa huonompana.
Parhaalle mallille annetaan indeksiarvo 1,0; pahimmalle mallille annetaan indeksiarvo -0,594.
Indeksille arvioitiin ryhmien väliset erot regressiolla ennustetussa muutoksessa peruspistemäärästä.
LS Keskiarvoa kontrolloitiin kohteille Hoito, käynti, Hoito*käynti ja lähtötaso.
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Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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Resurssien käyttö: Sairaalahoitoon joutuneiden osallistujien prosenttiosuus
Aikaikkuna: Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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Resurssien käyttöaste on sairaalahoidossa olevien osallistujien prosenttiosuus.
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Satunnaistamispäivästä tutkimuksen loppuun (jopa 32 kuukautta)
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Goskel T, Cortot AB, Girard N, Wesseler C, Bischoff H, Nadal E, Park K, Lu S, Taus A, Cobo M, Estrem ST, Wijayawardana SR, Turner K, Oakley GJ 3rd, Hurt KC, Chiang AY, Hossain AM, John WJ, Paz-Ares L. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756. doi: 10.3389/fonc.2020.578756. eCollection 2020.
- Goldman JW, Shi P, Reck M, Paz-Ares L, Koustenis A, Hurt KC. Treatment Rationale and Study Design for the JUNIPER Study: A Randomized Phase III Study of Abemaciclib With Best Supportive Care Versus Erlotinib With Best Supportive Care in Patients With Stage IV Non-Small-Cell Lung Cancer With a Detectable KRAS Mutation Whose Disease Has Progressed After Platinum-Based Chemotherapy. Clin Lung Cancer. 2016 Jan;17(1):80-4. doi: 10.1016/j.cllc.2015.08.003. Epub 2015 Aug 18.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Perjantai 3. lokakuuta 2014
Ensisijainen valmistuminen (Todellinen)
Perjantai 15. syyskuuta 2017
Opintojen valmistuminen (Arvioitu)
Tiistai 1. joulukuuta 2026
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Perjantai 23. toukokuuta 2014
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 29. toukokuuta 2014
Ensimmäinen Lähetetty (Arvioitu)
Maanantai 2. kesäkuuta 2014
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 6. helmikuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Maanantai 19. tammikuuta 2026
Viimeksi vahvistettu
Torstai 1. tammikuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Neoplasmat sivustoittain
- Neoplasmat
- Hengityselinten sairaudet
- Keuhkosairaudet
- Hengitysteiden kasvaimet
- Rintakehän kasvaimet
- Keuhkojen kasvaimet
- Syöpä, bronkogeeninen
- Keuhkoputkien kasvaimet
- Karsinooma, ei-pienisoluinen keuhko
- Heterosykliset yhdisteet
- Heterosykliset yhdisteet, 2-rengas
- Heterosykliset yhdisteet, sulatettu rengas
- Kinatsoliinit
- Erlotinibihydrokloridi
- abemaciclib
Muut tutkimustunnusnumerot
- 15296
- I3Y-MC-JPBK (Muu tunniste: Eli Lilly and Company)
- 2013-004662-33 (EudraCT-numero)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Anonymisoidut yksittäiset potilastason tiedot toimitetaan suojatussa käyttöympäristössä tutkimusehdotuksen ja allekirjoitetun tiedonjakosopimuksen hyväksymisen jälkeen.
IPD-jaon aikakehys
Tiedot ovat saatavilla 6 kuukauden kuluttua Yhdysvalloissa ja EU:ssa tutkitun käyttöaiheen ensisijaisesta julkaisusta ja hyväksymisestä sen mukaan, kumpi on myöhempi.
Tiedot ovat toistaiseksi saatavilla pyynnöstä.
IPD-jaon käyttöoikeuskriteerit
Tutkimusehdotuksen on hyväksyttävä riippumaton arviointipaneeli ja tutkijoiden on allekirjoitettava tiedonjakosopimus.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- CSR
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 .