Abemaciclib (LY2835219) 在既往治疗过 KRAS 突变肺癌受试者中的研究 (JUNIPER)
2026年1月19日 更新者:Eli Lilly and Company
JUNIPER:Abemaciclib 加最佳支持治疗与厄洛替尼加最佳支持治疗的随机 3 期研究,针对具有可检测到的 KRAS 突变且在铂类化疗后病情进展的 IV 期 NSCLC 患者
这项研究的主要目的是评估被称为 abemaciclib 的研究药物对肺癌参与者的安全性和有效性。
研究概览
研究类型
介入性
注册 (实际的)
453
阶段
- 第三阶段
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联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Beijing、中国、100071
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Beijing、中国、100021
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Beijing、中国、100730
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Changchun、中国、130012
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Changzhou、中国、213000
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Chengdu、中国、610041
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Haikou、中国、570311
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Hangzhou、中国、310022
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Hefei、中国、230001
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Nanning、中国、530021
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Shanghai、中国、200030
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Shenyang、中国、100042
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Dnipropetrovsk、乌克兰、49102
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Kharkiv、乌克兰、61070
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Kryvyi Rih、乌克兰、50048
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Kyiv、乌克兰、04107
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Lutsk、乌克兰、63000
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Poltava、乌克兰、36011
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Sumy、乌克兰、40005
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Uzhhorod、乌克兰、88000
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Vinnitsa、乌克兰、21029
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Beersheba、以色列、8410101
- Soroka Medical Center
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Holon、以色列、5822012
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Jerusalem、以色列、9112001
- Hadassah Medical Center - Ein Karem
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Kfar Saba、以色列、4428164
- Meir Medical Center
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Petah Tikva、以色列、4941492
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Tel Litwinsky、以色列、5265601
- Sheba medical center
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Arkhangelsk、俄罗斯、163045
- Arkhangelsk Regional Clinical Oncology Dispensary
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Chelyabinsk、俄罗斯、454048
- Private clinic "Evimed"
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Krasnodar、俄罗斯、350086
- Krasnodar regional clinical hospital # 1 n. a. S. V. Ochapovskogo
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Kursk、俄罗斯、305035
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Moscow、俄罗斯、115478
- Russian oncological scientific centre n.a. N.N. Blokhin of RAMS
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Saint Petersburg、俄罗斯、198255
- Saint-Petersburg City Clinical Oncology Dispensary
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Saint Petersburg、俄罗斯、197758
- St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)
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Ufa、俄罗斯、450054
- Republic clinical oncology dispensary of MoH of Bashkortostan Republic
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Volzhskiy、俄罗斯、404130
- Volgograd Regional Clinical Oncology Dispensary
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Calgary、加拿大、T2N 4N2
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Edmonton、加拿大、T6G 1Z2
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Montreal、加拿大、H2L 4M1
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Toronto、加拿大、M4N 3M5
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Vancouver、加拿大、V5Z 4E6
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Winnipeg、加拿大、R3A 1M3
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Chiayi City、台湾、613
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Kaohsiung City、台湾、83301
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Kaohsiung City、台湾、82445
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Taichung、台湾、40447
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Taichung、台湾、404
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Tainan、台湾、70403
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Taipei、台湾、10449
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Taipei、台湾、11217
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Taipei、台湾、10002
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Zhonghe、台湾、235
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Ankara、土耳其(türkiye)、06100
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Ankara、土耳其(türkiye)、06490
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Antalya、土耳其(türkiye)、07059
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Edirne、土耳其(türkiye)、22030
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Istanbul、土耳其(türkiye)、34020
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Istanbul、土耳其(türkiye)、34098
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Istanbul、土耳其(türkiye)、34890
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Izmir、土耳其(türkiye)、35100
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Graz、奥地利、8036
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Linz、奥地利、4020
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Linz、奥地利、4021
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Salzburg、奥地利、5020
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Ijuí、巴西、98700 000
- Associacao Hospital de Caridade Ijui
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Lajeados、巴西、95900-000
- Hospital Bruno Born
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Porto Alegre、巴西、90610-970
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Rio de Janeiro、巴西、20231-050
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Salvador、巴西、41253-190
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Sao Jose Rio Preto、巴西、15090-000
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São Paulo、巴西、01246000
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São Paulo、巴西、01509-010
- Fundação Antonio Prudente - Hospital do Câncer A.C Camargo
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Athens、希腊、11527
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Athens、希腊、11522
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Athens、希腊、18537
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Heraklion、希腊、71110
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Pátrai、希腊、26504
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Berlin、德国、14165
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Gera、德国、07548
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Großhansdorf、德国、22927
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Hamburg、德国、21075
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Hanover、德国、30459
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Heidelberg、德国、69126
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Immenhausen、德国、34376
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Nuremberg、德国、90419
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Regensburg、德国、93053
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Rosenheim、德国、83022
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Tübingen、德国、72076
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Ulm、德国、89081
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Catania、意大利、95125
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Genova、意大利、16132
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Livorno、意大利、57124
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Parma、意大利、43100
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Rome、意大利、00152
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Amagasaki、日本、660-0892
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Asahikawa、日本、070-8644
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Bunkyō City、日本、113-8431
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Bunkyō City、日本、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.
-
Fukuoka、日本、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.
-
Habikino、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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、日本、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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Bron、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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、法国、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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-
-
-
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Gdansk、波兰、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、波兰、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、波兰、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、波兰、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、波兰、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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San Juan、波多黎各、00921-3201
- VA Caribbean Healthcare System
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-
-
-
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Baia Mare、罗马尼亚、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、罗马尼亚、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、罗马尼亚、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、罗马尼亚、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、罗马尼亚、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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Arkansas
-
Fayetteville、Arkansas、美国、72703
- Highlands Oncology Group
-
Jonesboro、Arkansas、美国、72401
- St. Bernards Medical Center
-
-
California
-
Duarte、California、美国、91010
- City of Hope National Medical Center
-
La Jolla、California、美国、92037
- University of California - San Diego
-
Loma Linda、California、美国、92350
- Loma Linda University School of Medicine
-
Los Angeles、California、美国、90024
- SMO TRIO -Translational Research
-
Los Angeles、California、美国、90024
- CBCC Global Research, Inc.
-
Los Angeles、California、美国、90024
- Central Coast Medical Oncology Corporation
-
Los Angeles、California、美国、90024
- Fort Wayne Oncology & Hematology
-
Los Angeles、California、美国、90024
- St. Joseph Heritage Medical Group
-
Los Angeles、California、美国、90024
- UCLA Department of Medicine-Hematology/Oncology
-
Los Angeles、California、美国、90095
- Cancer Care Associates Medical Group
-
Sacramento、California、美国、95816
- Dignity Health Care Institute
-
-
Colorado
-
Englewood、Colorado、美国、80112
- SMO Catholic Health Initiatives
-
Englewood、Colorado、美国、80112
- Alegent Immanuel Cancer Center
-
Englewood、Colorado、美国、80112
- Jewish Hospital
-
Englewood、Colorado、美国、80112
- Oncology Hematology West
-
Englewood、Colorado、美国、80112
- St Joseph Cancer Center
-
Englewood、Colorado、美国、80112
- St. Francis Medical Center
-
-
Delaware
-
Newark、Delaware、美国、19713
- Medical Oncology Hematology Consultants
-
-
Florida
-
Boca Raton、Florida、美国、33486
- Boca Raton Regional Hospital
-
Daytona Beach、Florida、美国、32114
- Halifax Medical Center
-
Pembroke Pines、Florida、美国、33028
- Memorial Cancer Institute
-
Tampa、Florida、美国、33612-9497
- H Lee Moffitt Cancer Center
-
-
Georgia
-
Athens、Georgia、美国、30607
- University Cancer & Blood Center, LLC
-
-
Illinois
-
Harvey、Illinois、美国、60426
- Ingalls Memorial Hospital
-
-
Indiana
-
Indianapolis、Indiana、美国、46202
- Indiana University School of Medicine
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa
-
-
Kansas
-
Wichita、Kansas、美国、67214
- Cancer Center of Kansas, P.A.
-
-
Kentucky
-
Lexington、Kentucky、美国、40503
- Central Baptist Hospital
-
Louisville、Kentucky、美国、40202
- University of Louisville
-
-
Maryland
-
Bethesda、Maryland、美国、20889
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Framingham、Massachusetts、美国、01701
- Metro-West and Greater Boston CNS Research
-
-
Michigan
-
Detroit、Michigan、美国、48201
- Karmanos Cancer Institute
-
-
Missouri
-
Springfield、Missouri、美国、65807
- Mercy Medical Research Institute
-
-
Montana
-
Billings、Montana、美国、59101
- Billings Clinic Research Center
-
-
New Hampshire
-
Lebanon、New Hampshire、美国、03756
- Dartmouth Hitchcock Medical Center
-
-
New York
-
Johnson City、New York、美国、13790
- Broome Oncology
-
New York、New York、美国、10065
- Weill Cornell Medical College
-
-
Ohio
-
Cincinnati、Ohio、美国、45242
- Oncology Hematology Care Inc
-
-
Oklahoma
-
Tulsa、Oklahoma、美国、74146
- Oklahoma Cancer Specialists & Research Institute, LLC
-
-
Oregon
-
Portland、Oregon、美国、97213
- Providence Cancer Center Oncology Hematology Care
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- UPMC Hillman Cancer Center
-
-
South Carolina
-
Charleston、South Carolina、美国、29401
- Roper St. Francis Healthcare
-
-
Tennessee
-
Chattanooga、Tennessee、美国、37404
- Chattanooga Oncology Hematology Associates
-
Nashville、Tennessee、美国、37203
- Tennessee Oncology PLLC
-
Nashville、Tennessee、美国、37203
- Chattanooga Oncology Hematology Associates
-
-
Texas
-
Dallas、Texas、美国、75230
- Mary Crowley Cancer Research Center
-
-
Utah
-
Salt Lake City、Utah、美国、84106
- Utah Cancer Specialists
-
-
Vermont
-
Burlington、Vermont、美国、05401
- University of Vermont Medical Center
-
-
Virginia
-
Richmond、Virginia、美国、23298
- Virginia Commonwealth University
-
-
Washington
-
Kennewick、Washington、美国、99336
- Kadlec Clinical Hematology & Oncology
-
Seattle、Washington、美国、98104
- Swedish Medical Center
-
Valley、Washington、美国、99216
- Cancer Care Northwest
-
-
-
-
-
A Coruña、西班牙、15006
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Barcelona、西班牙、08003
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
L'Hospitalet de Llobregat、西班牙、08907
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Madrid、西班牙、28041
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Madrid、西班牙、28040
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Madrid、西班牙、28050
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Málaga、西班牙、29010
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Seville、西班牙、41013
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Valencia、西班牙、46026
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
-
-
-
Berazategui、阿根廷、B1884BBF
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Ciudad Autonoma Buenos Aires、阿根廷、1093
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ciudad Autonoma Buenos Aires、阿根廷、1025
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Ciudad Autonoma Buenos Aires、阿根廷、C1181AAX
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Rosario、阿根廷、2000
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Rosario、阿根廷、S2000DSV
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
-
Viedma、阿根廷、8500
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
-
-
-
-
Goyang-si、韩国、10408
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Incheon、韩国、21565
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Seoul、韩国、03722
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Seoul、韩国、05505
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
-
Seoul、韩国、06351
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Seoul、韩国、06591
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Seowon-Gu、韩国、28644
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Suwon、韩国、16247
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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Ulsan、韩国、44033
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) 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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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准:
- 根据美国癌症分期联合委员会手册,已确诊为 IV 期非小细胞肺癌 (NSCLC)。
- 通过研究中心实验室的研究测定,确定克尔斯滕大鼠肉瘤 (KRAS) 癌基因的密码子 12 或 13 存在可检测的突变。 每个当地实验室允许不超过 10% 的随机参与者出现 KRAS 癌基因密码子 12 或 13 的 KRAS 阳性突变结果。
- 在铂类化疗(有或没有维持治疗)后病情出现进展,并且已经接受了一种额外的治疗,其中可能包括针对晚期和/或转移性疾病的免疫检查点抑制剂或其他抗癌治疗,或者被医生判断为不适合进一步治疗标准二线化疗。 在铂类化疗和免疫检查点抑制剂(免疫疗法)后病情出现进展的参与者,例如 单独使用派姆单抗或纳武单抗或与其他药物联合使用均符合资格。
- 患有实体瘤疗效评估标准 (RECIST 1.1) 定义的可测量疾病。
- 在东部肿瘤合作组 (ECOG) 量表中,表现状态 (PS) 为 0 到 1。
- 在接受研究药物之前,已停止所有先前的癌症治疗(包括化疗、放疗、免疫治疗和研究治疗)至少 21 天(对于骨髓抑制剂)或 14 天(对于非骨髓抑制剂)。
排除标准:
- 分别在非骨髓抑制或骨髓抑制药物初始剂量研究药物 14 或 21 天内接受过未获得任何适应症监管批准的药物治疗。
- 有以下任何一种情况的个人病史:不明原因或心血管病因的先兆晕厥或晕厥、室性心律失常(包括但不限于室性心动过速和心室颤动)或心脏骤停。
- 存在不稳定的中枢神经系统(CNS)转移。 允许有中枢神经系统转移史或稳定的中枢神经系统转移(不再需要积极治疗,如类固醇药物)。 有中枢神经系统转移病史的参与者必须在随机分组后 28 天内进行脑部扫描(例如磁共振成像 [MRI]),以记录稳定性,即使症状没有变化。
- 之前已完成或退出本研究或任何其他研究细胞周期蛋白依赖性激酶 4 (CDK4) 和细胞周期蛋白依赖性激酶 6 (CDK6) 抑制剂的研究,或之前接受过 CDK4 和 CDK6 抑制剂的治疗。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Abemaciclib
每 12 小时口服 200 毫克 (mg) abemaciclib,并在第 1 至 28 天(28 天周期)进行最佳支持治疗 (BSC)。
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口服给药
其他名称:
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有源比较器:厄洛替尼
每 24 小时口服 150 mg 厄洛替尼,并在第 1 至 28 天进行 BSC(28 天周期)。
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口服给药
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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总生存期 (OS)
大体时间:从随机分组日期到全因死亡日期(最长 32 个月)
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OS 定义为从随机化日期到因任何原因死亡的日期。
对于截至总体生存分析的数据包含截止日期尚未死亡的每个参与者,OS 时间在已知参与者存活的最后日期进行审查。
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从随机分组日期到全因死亡日期(最长 32 个月)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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完全缓解 (CR) 或部分缓解 (PR) 的参与者百分比(客观缓解率 [ORR])
大体时间:从随机化日期到客观进展(长达 32 个月)
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ORR 是根据实体瘤疗效评估标准 (RECIST) v1.1 获得完全缓解 (CR) 或部分缓解 (PR) 的最佳总体缓解 (BOR) 的参与者的百分比。
CR定义为所有靶病灶和非靶病灶消失并且没有新病灶出现。
PR定义为目标病灶的最长直径总和(LD)减少至少30%(以基线LD总和为参考),非目标病灶无进展,且未出现新病灶。
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从随机化日期到客观进展(长达 32 个月)
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无进展生存期 (PFS)
大体时间:从随机分组日期到疾病进展或全因死亡(最长 32 个月)
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PFS 定义为从随机化日期到出现 RECIST v1.1 定义的疾病进展或任何原因死亡的第一个证据。
疾病进展 (PD) 是指目标病灶直径总和增加至少 20%(参考研究中最小总和且绝对增加至少 5 毫米),或非目标病灶明确进展,或1 个或多个新病灶。
如果参与者没有完整的基线疾病评估,则在首次给药之日对 PFS 时间进行审查,无论是否观察到参与者客观确定的疾病进展或死亡。
如果截至分析的数据纳入截止日期,未知参与者是否死亡或出现客观进展,则 PFS 时间将在最后一个适当的肿瘤评估日期进行审查。
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从随机分组日期到疾病进展或全因死亡(最长 32 个月)
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MD 安德森肺癌症状清单 (MDASI-LC) 评分相对于基线的变化
大体时间:从随机分组日期到研究结束(最长 32 个月)
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MDASI-LC 包括 22 个项目 + 3 个额外的试验特定项目,产生 6 个收集和报告的单一构建评分,包括核心症状(13 项)、干扰(6 项)、肺癌(3 项)和针对头痛、腹泻和皮疹的试验特定单一结果。
计算2-构建体复合核心+肺癌症状(16项)评分。
所有 7 个分数的数据均通过 11 点数字评分量表收集,分为 0(不存在或不干扰)和 10(如您想象的那么糟糕或完全干扰)。
测量范围为10(最高分-最低分)。
混合模型重复测量 (MMRM) 回归与治疗、就诊、治疗*就诊和基线评分的协变量预测组间最小二乘法 (LS) 与基线的平均差异。
群体水平相对于基线的负变化表明群体有所改善。
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从随机分组日期到研究结束(最长 32 个月)
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药代动力学 (PK):稳态下 1 个给药间隔期间浓度与时间曲线下的面积
大体时间:第 1 周期的第 1 天到第 3 周期(28 天周期)
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PK 由稳定状态下 1 个给药间隔期间血浆浓度与时间曲线下的面积确定
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第 1 周期的第 1 天到第 3 周期(28 天周期)
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欧洲生活质量相对于基线的变化 - 5 个维度 - 5 级 (EQ-5D-5L) 分数
大体时间:从随机分组日期到研究结束(最长 32 个月)
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从好到坏连续体有 5 个响应级别 1-5,分别对应于无、轻微、中等、严重和极端/无法。
采用 EuroQol 开发的人行横道法将 EQ-5D-5L、英国 (UK) 体重、健康维度(活动能力、自我护理、日常活动、疼痛/不适和焦虑/抑郁)转换为单一指数价值;尺寸不单独评分。
当缺失 ≥1 个维度时,索引将被标记为缺失。
反应模式的指数得分以完全健康到死亡为基础,负值分配给被认为比死亡更糟糕的反应模式/健康状态。
最好的模式被分配索引值1.0;最差模式的索引值为-0.594。
估计了该指数的回归预测相对于基线评分的变化的组间差异。
LS 平均值针对治疗、就诊、治疗*就诊和基线进行控制。
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从随机分组日期到研究结束(最长 32 个月)
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资源利用率:住院参与者的百分比
大体时间:从随机分组日期到研究结束(最长 32 个月)
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资源利用率是住院参与者的百分比。
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从随机分组日期到研究结束(最长 32 个月)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任: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
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2014年10月3日
初级完成 (实际的)
2017年9月15日
研究完成 (估计的)
2026年12月1日
研究注册日期
首次提交
2014年5月23日
首先提交符合 QC 标准的
2014年5月29日
首次发布 (估计的)
2014年6月2日
研究记录更新
最后更新发布 (实际的)
2026年2月6日
上次提交的符合 QC 标准的更新
2026年1月19日
最后验证
2026年1月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 15296
- I3Y-MC-JPBK (其他标识符:Eli Lilly and Company)
- 2013-004662-33 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
研究提案获得批准并签署数据共享协议后,将在安全访问环境中提供匿名的个体患者级别数据。
IPD 共享时间框架
数据在美国和欧盟研究的适应症首次发表和批准后 6 个月提供,以较晚者为准。
数据将无限期地可供请求。
IPD 共享访问标准
研究提案必须得到独立审查小组的批准,研究人员必须签署数据共享协议。
IPD 共享支持信息类型
- 研究方案
- 树液
- 企业社会责任
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.