Une étude sur l'abémaciclib (LY2835219) chez des participants atteints d'un cancer du poumon muté KRAS précédemment traité (JUNIPER)
19 janvier 2026 mis à jour par: Eli Lilly and Company
JUNIPER : Une étude randomisée de phase 3 sur l'Abémaciclib Plus les meilleurs soins de soutien par rapport à l'Erlotinib Plus les meilleurs soins de soutien chez les patients atteints d'un CPNPC de stade IV avec une mutation KRAS détectable qui ont progressé après une chimiothérapie à base de platine
L'objectif principal de cette étude est d'évaluer dans quelle mesure le médicament à l'étude connu sous le nom d'abémaciclib est sûr et efficace chez les participants atteints d'un cancer du poumon.
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
453
Phase
- Phase 3
Accès étendu
Approuvé en vente au public.
Voir enregistrement d'accès étendu.
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Berlin, Allemagne, 14165
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Gera, Allemagne, 07548
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Großhansdorf, Allemagne, 22927
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Hamburg, Allemagne, 21075
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Hanover, Allemagne, 30459
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Heidelberg, Allemagne, 69126
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Immenhausen, Allemagne, 34376
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Nuremberg, Allemagne, 90419
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Regensburg, Allemagne, 93053
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Rosenheim, Allemagne, 83022
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Tübingen, Allemagne, 72076
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Ulm, Allemagne, 89081
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Berazategui, Argentine, B1884BBF
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Ciudad Autonoma Buenos Aires, Argentine, 1093
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Ciudad Autonoma Buenos Aires, Argentine, 1025
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Ciudad Autonoma Buenos Aires, Argentine, C1181AAX
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Rosario, Argentine, 2000
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Rosario, Argentine, S2000DSV
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Viedma, Argentine, 8500
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Ijuí, Brésil, 98700 000
- Associacao Hospital de Caridade Ijui
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Lajeados, Brésil, 95900-000
- Hospital Bruno Born
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Porto Alegre, Brésil, 90610-970
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Rio de Janeiro, Brésil, 20231-050
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Salvador, Brésil, 41253-190
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Sao Jose Rio Preto, Brésil, 15090-000
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São Paulo, Brésil, 01246000
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São Paulo, Brésil, 01509-010
- Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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Calgary, Canada, 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, Canada, T6G 1Z2
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Montreal, Canada, H2L 4M1
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Toronto, Canada, M4N 3M5
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Vancouver, Canada, V5Z 4E6
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Winnipeg, Canada, R3A 1M3
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Beijing, Chine, 100071
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Beijing, Chine, 100021
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Beijing, Chine, 100730
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Changchun, Chine, 130012
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Changzhou, Chine, 213000
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Chengdu, Chine, 610041
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Haikou, Chine, 570311
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Hangzhou, Chine, 310022
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Hefei, Chine, 230001
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Nanning, Chine, 530021
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Shanghai, Chine, 200030
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Shenyang, Chine, 100042
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Goyang-si, Corée du Sud, 10408
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Incheon, Corée du Sud, 21565
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Seoul, Corée du Sud, 03722
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Seoul, Corée du Sud, 05505
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Seoul, Corée du Sud, 06351
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Seoul, Corée du Sud, 06591
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Seowon-Gu, Corée du Sud, 28644
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Suwon, Corée du Sud, 16247
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Ulsan, Corée du Sud, 44033
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A Coruña, Espagne, 15006
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Barcelona, Espagne, 08003
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L'Hospitalet de Llobregat, Espagne, 08907
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Madrid, Espagne, 28041
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Madrid, Espagne, 28040
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Madrid, Espagne, 28050
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Málaga, Espagne, 29010
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Seville, Espagne, 41013
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Valencia, Espagne, 46026
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Bron, France, 69677
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Dijon, France, 21034
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Grenoble, France, 38043
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Lille, France, 59037
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Marseille, France, 13015
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Poitiers, France, 86021
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Rennes, France, 35033
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Saint-Brieuc, France, 22027
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Saint-Priest-en-Jarez, France, 42270
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Toulouse, France, 31059
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Vantoux, France, 57070
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Athens, Grèce, 11527
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Athens, Grèce, 11522
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Athens, Grèce, 18537
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Heraklion, Grèce, 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.
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Pátrai, Grèce, 26504
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Beersheba, Israël, 8410101
- Soroka Medical Center
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Holon, Israël, 5822012
- 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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Jerusalem, Israël, 9112001
- Hadassah Medical Center - Ein Karem
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Kfar Saba, Israël, 4428164
- Meir Medical Center
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Petah Tikva, Israël, 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, Israël, 5265601
- Sheba medical center
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Catania, Italie, 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, Italie, 16132
- 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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Livorno, Italie, 57124
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Parma, Italie, 43100
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Rome, Italie, 00152
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Amagasaki, Japon, 660-0892
- 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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Asahikawa, Japon, 070-8644
- 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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Bunkyō City, Japon, 113-8431
- 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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Bunkyō City, Japon, 113-8677
- 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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Fukuoka, Japon, 811-1395
- 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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Habikino, Japon, 583-8588
- 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.
-
Hirakata, Japon, 573-1191
- 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.
-
Hiroshima, Japon, 734-8551
- 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.
-
Hyōgo, Japon, 6608550
- 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.
-
Kanazawa, Japon, 920-8641
- 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.
-
Kashiwa, Japon, 277 8577
- 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.
-
Kishiwada, Japon, 596-8501
- 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.
-
Kitaadachi-Gun, Japon, 362-0806
- 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.
-
Kobe, Japon, 650-0047
- 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.
-
Kurashiki, Japon, 710-8602
- 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.
-
Kōtoku, Japon, 135-8550
- 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.
-
Matsuyama, Japon, 791-0280
- 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.
-
Nagasaki, Japon, 852-8501
- 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.
-
Nagoya, Japon, 464-8681
- 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.
-
Nagoya, Japon, 466-8560
- 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.
-
Natori, Japon, 981-1293
- 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.
-
Okayama, Japon, 700-8558
- 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.
-
Osaka, Japon, 545-8586
- 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.
-
Osaka, Japon, 534-0021
- 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.
-
Osaka, Japon, 537-8511
- 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.
-
Sakai, Japon, 5918555
- 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.
-
Sayama, Japon, 589-8511
- 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.
-
Sendai, Japon, 980-0873
- 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.
-
Shinjuku-ku, Japon, 160-0023
- 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.
-
Sunto-Gun, Japon, 411-8777
- 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.
-
Ube, Japon, 755-0241
- 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.
-
Utsunomiya, Japon, 320-0834
- 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.
-
Wakayama, Japon, 641-8510
- 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.
-
Yokohama, Japon, 236-0004
- 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.
-
Yonago, Japon, 683-0826
- 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.
-
Yufu-shi, Japon, 8795593
- 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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Graz, L'Autriche, 8036
- 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.
-
Linz, L'Autriche, 4020
- 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
-
Linz, L'Autriche, 4021
- 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.
-
Salzburg, L'Autriche, 5020
- 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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Gdansk, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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, Pologne, 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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-
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San Juan, Porto Rico, 00921-3201
- VA Caribbean Healthcare System
-
-
-
-
-
Baia Mare, Roumanie, 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, Roumanie, 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, Roumanie, 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, Roumanie, 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, Roumanie, 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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Arkhangelsk, Russie, 163045
- Arkhangelsk Regional Clinical Oncology Dispensary
-
Chelyabinsk, Russie, 454048
- Private clinic "Evimed"
-
Krasnodar, Russie, 350086
- Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
-
Kursk, Russie, 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, Russie, 115478
- Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
-
Saint Petersburg, Russie, 198255
- Saint-Petersburg City Clinical Oncology Dispensary
-
Saint Petersburg, Russie, 197758
- St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
-
Ufa, Russie, 450054
- Republic clinical oncology dispensary of MoH of Bashkortostan Republic
-
Volzhskiy, Russie, 404130
- Volgograd Regional Clinical Oncology Dispensary
-
-
-
-
-
Chiayi City, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Taïwan, 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, Turquie (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, Turquie (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, Turquie (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, Turquie (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, Turquie (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, Turquie (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, Turquie (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, Turquie (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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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, Ukraine, 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.
-
-
-
-
Arkansas
-
Fayetteville, Arkansas, États-Unis, 72703
- Highlands Oncology Group
-
Jonesboro, Arkansas, États-Unis, 72401
- St. Bernards Medical Center
-
-
California
-
Duarte, California, États-Unis, 91010
- City of Hope National Medical Center
-
La Jolla, California, États-Unis, 92037
- University of California - San Diego
-
Loma Linda, California, États-Unis, 92350
- Loma Linda University School of Medicine
-
Los Angeles, California, États-Unis, 90024
- SMO TRIO -Translational Research
-
Los Angeles, California, États-Unis, 90024
- CBCC Global Research, Inc.
-
Los Angeles, California, États-Unis, 90024
- Central Coast Medical Oncology Corporation
-
Los Angeles, California, États-Unis, 90024
- Fort Wayne Oncology & Hematology
-
Los Angeles, California, États-Unis, 90024
- St. Joseph Heritage Medical Group
-
Los Angeles, California, États-Unis, 90024
- UCLA Department of Medicine-Hematology/Oncology
-
Los Angeles, California, États-Unis, 90095
- Cancer Care Associates Medical Group
-
Sacramento, California, États-Unis, 95816
- Dignity Health Care Institute
-
-
Colorado
-
Englewood, Colorado, États-Unis, 80112
- SMO Catholic Health Initiatives
-
Englewood, Colorado, États-Unis, 80112
- Alegent Immanuel Cancer Center
-
Englewood, Colorado, États-Unis, 80112
- Jewish Hospital
-
Englewood, Colorado, États-Unis, 80112
- Oncology Hematology West
-
Englewood, Colorado, États-Unis, 80112
- St Joseph Cancer Center
-
Englewood, Colorado, États-Unis, 80112
- St. Francis Medical Center
-
-
Delaware
-
Newark, Delaware, États-Unis, 19713
- Medical Oncology Hematology Consultants
-
-
Florida
-
Boca Raton, Florida, États-Unis, 33486
- Boca Raton Regional Hospital
-
Daytona Beach, Florida, États-Unis, 32114
- Halifax Medical Center
-
Pembroke Pines, Florida, États-Unis, 33028
- Memorial Cancer Institute
-
Tampa, Florida, États-Unis, 33612-9497
- H Lee Moffitt Cancer Center
-
-
Georgia
-
Athens, Georgia, États-Unis, 30607
- University Cancer & Blood Center, LLC
-
-
Illinois
-
Harvey, Illinois, États-Unis, 60426
- Ingalls Memorial Hospital
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Indiana University School of Medicine
-
-
Iowa
-
Iowa City, Iowa, États-Unis, 52242
- University of Iowa
-
-
Kansas
-
Wichita, Kansas, États-Unis, 67214
- Cancer Center of Kansas, P.A.
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40503
- Central Baptist Hospital
-
Louisville, Kentucky, États-Unis, 40202
- University of Louisville
-
-
Maryland
-
Bethesda, Maryland, États-Unis, 20889
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Framingham, Massachusetts, États-Unis, 01701
- Metro-West and Greater Boston CNS Research
-
-
Michigan
-
Detroit, Michigan, États-Unis, 48201
- Karmanos Cancer Institute
-
-
Missouri
-
Springfield, Missouri, États-Unis, 65807
- Mercy Medical Research Institute
-
-
Montana
-
Billings, Montana, États-Unis, 59101
- Billings Clinic Research Center
-
-
New Hampshire
-
Lebanon, New Hampshire, États-Unis, 03756
- Dartmouth Hitchcock Medical Center
-
-
New York
-
Johnson City, New York, États-Unis, 13790
- Broome Oncology
-
New York, New York, États-Unis, 10065
- Weill Cornell Medical College
-
-
Ohio
-
Cincinnati, Ohio, États-Unis, 45242
- Oncology Hematology Care Inc
-
-
Oklahoma
-
Tulsa, Oklahoma, États-Unis, 74146
- Oklahoma Cancer Specialists & Research Institute, LLC
-
-
Oregon
-
Portland, Oregon, États-Unis, 97213
- Providence Cancer Center Oncology Hematology Care
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, États-Unis, 15213
- UPMC Hillman Cancer Center
-
-
South Carolina
-
Charleston, South Carolina, États-Unis, 29401
- Roper St. Francis Healthcare
-
-
Tennessee
-
Chattanooga, Tennessee, États-Unis, 37404
- Chattanooga Oncology Hematology Associates
-
Nashville, Tennessee, États-Unis, 37203
- Tennessee Oncology PLLC
-
Nashville, Tennessee, États-Unis, 37203
- Chattanooga Oncology Hematology Associates
-
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Texas
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Dallas, Texas, États-Unis, 75230
- Mary Crowley Cancer Research Center
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Utah
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Salt Lake City, Utah, États-Unis, 84106
- Utah Cancer Specialists
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Vermont
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Burlington, Vermont, États-Unis, 05401
- University of Vermont Medical Center
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Virginia
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Richmond, Virginia, États-Unis, 23298
- Virginia Commonwealth University
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Washington
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Kennewick, Washington, États-Unis, 99336
- Kadlec Clinical Hematology & Oncology
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Seattle, Washington, États-Unis, 98104
- Swedish Medical Center
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Valley, Washington, États-Unis, 99216
- Cancer Care Northwest
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Avoir un diagnostic confirmé de cancer du poumon non à petites cellules (CPNPC) de stade IV selon l'American Joint Committee on Cancer Staging Handbook.
- Déterminé comme ayant des mutations détectables dans les codons 12 ou 13 de l'oncogène du sarcome du rat Kirsten (KRAS) par un test expérimental au laboratoire central de l'étude. Un résultat de mutation KRAS positif dans les codons 12 ou 13 de l'oncogène KRAS du tissu tumoral par laboratoire local sera autorisé chez pas plus de 10 % des participants randomisés.
- ont progressé après une chimiothérapie à base de platine (avec ou sans traitement d'entretien) ET ont reçu un traitement supplémentaire pouvant inclure un inhibiteur de point de contrôle immunitaire ou un autre traitement anticancéreux pour une maladie avancée et/ou métastatique OU sont jugés par le médecin comme inéligibles à d'autres traitements. chimiothérapie standard de deuxième intention. Les participants qui ont progressé après une chimiothérapie à base de platine et un inhibiteur de point de contrôle immunitaire (immunothérapie), par ex. le pembrolizumab ou le nivolumab seuls ou en association avec d'autres agents sont éligibles.
- Avoir une maladie mesurable telle que définie par les critères d'évaluation de la réponse dans les tumeurs solides (RECIST 1.1).
- Avoir un indice de performance (PS) de 0 à 1 sur l’échelle ECOG (Eastern Cooperative Oncology Group).
- Avoir interrompu tous les traitements antérieurs contre le cancer (y compris la chimiothérapie, la radiothérapie, l'immunothérapie et thérapie expérimentale) pendant au moins 21 jours pour les agents myélosuppresseurs ou 14 jours pour les agents non myélosuppresseurs avant de recevoir le médicament à l'étude.
Critère d'exclusion:
- Avoir reçu un traitement avec un médicament qui n'a pas reçu d'approbation réglementaire pour quelque indication que ce soit dans les 14 ou 21 jours suivant la dose initiale du médicament à l'étude pour un agent non myélosuppresseur ou myélosuppresseur, respectivement.
- Avoir des antécédents personnels de l'une des affections suivantes : présyncope ou syncope d'étiologie inexpliquée ou cardiovasculaire, arythmie ventriculaire (y compris, mais sans s'y limiter, la tachycardie ventriculaire et la fibrillation ventriculaire) ou arrêt cardiaque soudain.
- Avoir la présence de métastases instables du système nerveux central (SNC). Des antécédents de métastases du SNC ou de métastases stables du SNC sont autorisés (ne nécessitant plus de traitement actif tel que les médicaments stéroïdiens). Les participants ayant des antécédents de métastases du SNC doivent subir une scintigraphie cérébrale (par exemple, imagerie par résonance magnétique [IRM]) dans les 28 jours suivant la randomisation pour documenter la stabilité, même s'il n'y a eu aucun changement dans les symptômes.
- Avoir déjà terminé ou retiré de cette étude ou de toute autre étude portant sur un inhibiteur de la kinase 4 dépendante de la cycline (CDK4) et de la kinase 6 dépendante de la cycline (CDK6), ou avoir reçu un traitement avec un inhibiteur antérieur de CDK4 et CDK6.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Abémaciclib
200 milligrammes (mg) d'abémaciclib administrés par voie orale toutes les 12 heures plus les meilleurs soins de soutien (BSC) les jours 1 à 28 (cycles de 28 jours).
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Administré par voie orale
Autres noms:
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Comparateur actif: Erlotinib
150 mg d'erlotinib administrés par voie orale toutes les 24 heures plus BSC les jours 1 à 28 (cycles de 28 jours).
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Administré par voie orale
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Survie globale (OS)
Délai: De la date de randomisation à la date du décès quelle qu'en soit la cause (jusqu'à 32 mois)
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SG définie à partir de la date de randomisation jusqu'à la date du décès, quelle qu'en soit la cause.
Pour chaque participant dont on ne sait pas qu'il est décédé à la date limite d'inclusion des données pour l'analyse de la survie globale, le temps de SG a été censuré à la dernière date à laquelle le participant est connu comme étant en vie.
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De la date de randomisation à la date du décès quelle qu'en soit la cause (jusqu'à 32 mois)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pourcentage de participants avec une réponse complète (RC) ou une réponse partielle (RP) (taux de réponse objective [ORR])
Délai: De la date de randomisation à la progression objective (jusqu'à 32 mois)
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L'ORR était le pourcentage de participants obtenant une meilleure réponse globale (BOR) de réponse complète (CR) ou de réponse partielle (PR) selon les critères d'évaluation de la réponse dans les tumeurs solides (RECIST) v1.1.
CR défini comme la disparition de toutes les lésions cibles et non cibles et l'absence d'apparition de nouvelles lésions.
PR défini comme une diminution d'au moins 30 % de la somme des diamètres les plus longs (LD) des lésions cibles (en prenant comme référence la somme de base LD), aucune progression des lésions non cibles et aucune apparition de nouvelles lésions.
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De la date de randomisation à la progression objective (jusqu'à 32 mois)
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Survie sans progression (PFS)
Délai: De la date de randomisation jusqu'à la progression de la maladie ou le décès quelle qu'en soit la cause (jusqu'à 32 mois)
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PFS définie comme la date de randomisation jusqu'au premier signe de progression de la maladie telle que définie par RECIST v1.1 ou de décès quelle qu'en soit la cause.
La maladie évolutive (MP) était une augmentation d'au moins 20 % de la somme des diamètres des lésions cibles, la référence étant la plus petite somme de l'étude et une augmentation absolue d'au moins 5 mm, ou une progression sans équivoque des lésions non cibles, ou 1 ou plusieurs nouvelles lésions.
Si un participant ne dispose pas d'une évaluation de base complète de la maladie, alors le temps de SSP a été censuré à la date de la première dose, indépendamment du fait qu'une progression de la maladie ou un décès objectivement déterminé ait été observé ou non pour le participant.
Si un participant n'était pas décédé ou n'avait pas de progression objective à la date limite d'inclusion des données pour l'analyse, le temps de SSP était censuré à la dernière date d'évaluation adéquate de la tumeur.
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De la date de randomisation jusqu'à la progression de la maladie ou le décès quelle qu'en soit la cause (jusqu'à 32 mois)
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Changement par rapport à la valeur initiale du score MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC)
Délai: De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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Le MDASI-LC comprenait 22 éléments + 3 éléments supplémentaires spécifiques à l'essai, ce qui a donné lieu à 6 scores à construction unique collectés et rapportés, y compris les symptômes principaux (13 éléments), l'interférence (6 éléments), le cancer du poumon (3 éléments) et critères de jugement uniques spécifiques à l'essai concernant les maux de tête, la diarrhée et les éruptions cutanées.
Un score composite à 2 éléments + symptôme du cancer du poumon (16 items) a été calculé.
Les données pour les 7 scores ont été collectées à l'aide d'une échelle d'évaluation numérique de 11 points ancrée à 0 (absent ou n'interfère pas) et 10 (aussi mauvais que vous pouvez l'imaginer ou interféré complètement).
La plage de mesure était de 10 (score maximum-score minimum).
La régression à mesure répétée de modèle mixte (MMRM) avec des covariables pour le traitement, la visite, le traitement*visite et le score de base prédit les différences moyennes des moindres carrés (LS) entre les groupes par rapport à la ligne de base.
Un changement négatif au niveau du groupe par rapport à la ligne de base indique une amélioration du groupe.
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De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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Pharmacocinétique (PK) : aire sous la courbe concentration/temps pendant 1 intervalle de dosage à l'état d'équilibre
Délai: Jour 1 du cycle 1 au cycle 3 (cycles de 28 jours)
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La pharmacocinétique est déterminée par l'aire sous la courbe de concentration plasmatique en fonction du temps pendant 1 intervalle de dosage à l'état d'équilibre.
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Jour 1 du cycle 1 au cycle 3 (cycles de 28 jours)
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Changement par rapport à la ligne de base de la qualité de vie européenne - 5 dimensions - score de niveau 5 (EQ-5D-5L)
Délai: De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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Il existe 5 niveaux de réponse sur un continuum de bon à mauvais de 1 à 5 correspondant à aucun, léger, modéré, grave et extrême/incapable de le faire.
La méthode de concordance développée par EuroQol a été utilisée pour convertir l'EQ-5D-5L, en utilisant les poids du Royaume-Uni (Royaume-Uni), les dimensions de santé (mobilité, soins personnels, activités habituelles, douleur/inconfort et anxiété/dépression) en un seul indice. valeur; les dimensions ne sont pas notées séparément.
L'index est marqué comme manquant lorsqu'il manque ≥1 dimensions.
Les scores d'indice pour les modèles de réponse étaient ancrés sur la pleine santé jusqu'au décès, avec des valeurs négatives attribuées aux modèles de réponse/états de santé considérés comme pires que la mort.
Le meilleur modèle se voit attribuer la valeur d'indice de 1,0 ; le pire modèle se voit attribuer une valeur d’indice de -0,594.
Les différences entre les groupes dans la variation prévue par la régression par rapport au score de base ont été estimées pour l'indice.
La valeur moyenne LS a été contrôlée pour le traitement, la visite, le traitement*visite et la ligne de base.
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De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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Utilisation des ressources : pourcentage de participants hospitalisés
Délai: De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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L'utilisation des ressources est le pourcentage de participants hospitalisés.
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De la date de randomisation jusqu'à la fin de l'étude (jusqu'à 32 mois)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: 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
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
3 octobre 2014
Achèvement primaire (Réel)
15 septembre 2017
Achèvement de l'étude (Estimé)
1 décembre 2026
Dates d'inscription aux études
Première soumission
23 mai 2014
Première soumission répondant aux critères de contrôle qualité
29 mai 2014
Première publication (Estimé)
2 juin 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
6 février 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 janvier 2026
Dernière vérification
1 janvier 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies des voies respiratoires
- Maladies pulmonaires
- Tumeurs des voies respiratoires
- Tumeurs thoraciques
- Tumeurs pulmonaires
- Carcinome bronchique
- Tumeurs bronchiques
- Carcinome pulmonaire non à petites cellules
- Composés hétérocycliques
- Composés hétérocycliques, 2 anneaux
- Composés hétérocycliques, anneau fusionné
- Quinazolines
- Chlorhydrate d'erlotinib
- abemaciclib
Autres numéros d'identification d'étude
- 15296
- I3Y-MC-JPBK (Autre identifiant: Eli Lilly and Company)
- 2013-004662-33 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Les données anonymisées au niveau des patients individuels seront fournies dans un environnement d'accès sécurisé après approbation d'une proposition de recherche et d'un accord de partage de données signé.
Délai de partage IPD
Les données sont disponibles 6 mois après la publication principale et l'approbation de l'indication étudiée aux États-Unis et dans l'UE, la date la plus tardive étant retenue.
Les données seront disponibles indéfiniment pour la demande.
Critères d'accès au partage IPD
Une proposition de recherche doit être approuvée par un comité d'examen indépendant et les chercheurs doivent signer un accord de partage de données.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .