MK-1084(KRAS G12C 억제제) 및 더발루맙(Durvalumab)을 비소세포폐암 환자에게 투여하는 임상 시험(MK-1084-015/KANDLELIT-015)
2026년 11월 11일 업데이트: Merck Sharp & Dohme LLC
MK-1084 병용 Durvalumab 대 위약 병용 Durvalumab의 3상, 무작위 배정, 이중 눈가림, 위약 및 활성 대조약 대조 연구: 근치적 백금 기반 화학방사선요법 후 질병 진행이 없는 국소 진행성, 절제 불가능한 KRAS G12C 돌연변이 비소세포폐암 참가자 대상 (KANDLELIT-015)
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.
The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
연구 개요
연구 유형
중재적
등록 (추정된)
310
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Toll Free Number
- 전화번호: 1-888-577-8839
- 이메일: Trialsites@msd.com
연구 장소
-
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Attica
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Athens, Attica, 그리스, 151 25
- 모병
- Athens Medical Center ( Site 1201)
-
연락하다:
- Study Coordinator
- 전화번호: +306986817837
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Athens, Attica, 그리스, 115 28
- 모병
- ALEXANDRA General Hospital of Athens ( Site 1200)
-
연락하다:
- Study Coordinator
- 전화번호: +306934137080
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Athens, Attica, 그리스, 115 27
- 모병
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1205)
-
연락하다:
- Study Coordinator
- 전화번호: +302107700220
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Piraeus, Attica, 그리스, 185 37
- 모병
- Metaxa Cancer Hospital of Piraeus ( Site 1203)
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연락하다:
- Study Coordinator
- 전화번호: +306940583449
-
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East Macedonia and Thrace
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Alexandroupoli, East Macedonia and Thrace, 그리스, 681 00
- 모병
- University General Hospital of Alexandroupoli ( Site 1206)
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연락하다:
- Study Coordinator
- 전화번호: +306973489404
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-
-
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Groningen, 네덜란드, 9713 GZ
- 모병
- University Medical Center Groningen ( Site 1505)
-
연락하다:
- Study Coordinator
- 전화번호: +31503614679
-
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Gelderland
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Nijmegen, Gelderland, 네덜란드, 6525 GA
- 모병
- Radboudumc ( Site 1504)
-
연락하다:
- Study Coordinator
- 전화번호: + 31243610353
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Overijssel
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Hengelo, Overijssel, 네덜란드, 7555 DL
- 모병
- Ziekenhuis Groep Twente, locatie Hengelo ( Site 1500)
-
연락하다:
- Study Coordinator
- 전화번호: 0031887083454
-
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South Holland
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Leiden, South Holland, 네덜란드, 2333 ZA
- 모병
- Leids Universitair Medisch Centrum ( Site 1503)
-
연락하다:
- Study Coordinator
- 전화번호: +31715566376
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-
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New Taipei City, 대만, 23561
- 모병
- Taipei Medical University Shuang Ho Hospital ( Site 2612)
-
연락하다:
- Study Coordinator
- 전화번호: +886-970-747-515
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Tainan, 대만, 704
- 모병
- National Cheng Kung University Hospital ( Site 2601)
-
연락하다:
- Study Coordinator
- 전화번호: +886-6-2353535#3120
-
Taipei, 대만, 10449
- 모병
- Mackay Memorial Hospital ( Site 2611)
-
연락하다:
- Study Coordinator
- 전화번호: +886-2543-3535
-
Taipei, 대만, 114
- 모병
- Tri-Service General Hospital ( Site 2608)
-
연락하다:
- Study Coordinator
- 전화번호: +886287923311
-
Taipei, 대만, 106
- 모병
- National Taiwan University Cancer Center (NTUCC) ( Site 2610)
-
연락하다:
- Study Coordinator
- 전화번호: +886-2-2312-3456
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-
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital, Yonsei University Health System ( Site 2501)
-
연락하다:
- Study Coordinator
- 전화번호: 82-2-2228-0831
-
Seoul, 대한민국, 05505
- 모병
- Asan Medical Center ( Site 2500)
-
연락하다:
- Study Coordinator
- 전화번호: +82230103214
-
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Kyonggi-do
-
Goyang-si, Kyonggi-do, 대한민국, 10408
- 모병
- National Cancer Center ( Site 2505)
-
연락하다:
- Study Coordinator
- 전화번호: +82319201694
-
Suwon, Kyonggi-do, 대한민국, 16499
- 모병
- Ajou University Hospital ( Site 2504)
-
연락하다:
- Study Coordinator
- 전화번호: +8216886114
-
-
North Chungcheong
-
Cheongju-si, North Chungcheong, 대한민국, 28644
- 모병
- Chungbuk National University Hospital ( Site 2502)
-
연락하다:
- Study Coordinator
- 전화번호: +82432696015
-
-
Taegu-Kwangyokshi
-
Daegu, Taegu-Kwangyokshi, 대한민국, 42601
- 모병
- Keimyung University Dongsan Hospital ( Site 2503)
-
연락하다:
- Study Coordinator
- 전화번호: +82532586671
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Hamburg, 독일, 22087
- 모병
- Katholisches Marienkrankenhaus gGmbH ( Site 1101)
-
연락하다:
- Study Coordinator
- 전화번호: +494025460
-
Hamburg, 독일, 20246
- 모병
- Universitaetsklinikum Hamburg-Eppendorf ( Site 1111)
-
연락하다:
- Study Coordinator
- 전화번호: +4940741057118
-
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North Rhine-Westphalia
-
Münster, North Rhine-Westphalia, 독일, 48153
- 모병
- Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
-
연락하다:
- Study Coordinator
- 전화번호: +492519764537
-
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Georgia
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Atlanta, Georgia, 미국, 30318
- 모병
- Piedmont Atlanta Hospital ( Site 0121)
-
연락하다:
- Study Coordinator
- 전화번호: 999-999-9999
-
Savannah, Georgia, 미국, 31404
- 모병
- Low Country Cancer Care ( Site 0155)
-
연락하다:
- Study Coordinator
- 전화번호: 912-692-2000
-
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Illinois
-
Lisle, Illinois, 미국, 60532
- 모병
- Duly Healthcare ( Site 0158)
-
연락하다:
- Study Coordinator
- 전화번호: 630-545-7760
-
-
Nebraska
-
Lincoln, Nebraska, 미국, 68506
- 모병
- NHO Revive Research Institute LLC ( Site 0118)
-
연락하다:
- Study Coordinator
- 전화번호: 402-484-4900
-
-
New Jersey
-
New Brunswick, New Jersey, 미국, 08901
- 모병
- Rutgers Cancer Institute of New Jersey ( Site 0100)
-
연락하다:
- Study Coordinator
- 전화번호: 732-395-8823
-
-
New York
-
Albany, New York, 미국, 12206
- 모병
- New York Oncology Hematology P.C ( Site 9000)
-
연락하다:
- Study Coordinator
- 전화번호: 518-489-0044
-
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North Carolina
-
Raleigh, North Carolina, 미국, 27610
- 모병
- WakeMed Raleigh Campus ( Site 0144)
-
연락하다:
- Study Coordinator
- 전화번호: 919-350-2873
-
-
Virginia
-
Fairfax, Virginia, 미국, 22031
- 모병
- Virginia Cancer Specialists ( Site 0114)
-
연락하다:
- Study Coordinator
- 전화번호: 703-208-3110
-
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-
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Ceará
-
Fortaleza, Ceará, 브라질, 60336-232
- 모병
- CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406)
-
연락하다:
- Study Coordinator
- 전화번호: +55 85 32865934
-
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Espírito Santo
-
Vitória, Espírito Santo, 브라질, 29043-260
- 모병
- AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)
-
연락하다:
- Study Coordinator
- 전화번호: +5527998469004
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90020-090
- 모병
- Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0415)
-
연락하다:
- Study Coordinator
- 전화번호: +555132148107
-
-
Santa Catarina
-
Florianópolis, Santa Catarina, 브라질, 88034-000
- 모병
- CEPON ( Site 0413)
-
연락하다:
- Study Coordinator
- 전화번호: +554833311553
-
-
São Paulo
-
Barretos, São Paulo, 브라질, 14784-400
- 모병
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)
-
연락하다:
- Study Coordinator
- 전화번호: +551733216638
-
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-
-
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Barcelona, 스페인, 08035
- 모병
- Hospital Universitari Vall d'Hebron ( Site 1800)
-
연락하다:
- Study Coordinator
- 전화번호: +34932746000
-
Madrid, 스페인, 28040
- 모병
- Hospital Clinico San Carlos ( Site 1810)
-
연락하다:
- Study Coordinator
- 전화번호: +34913303000x484835
-
Madrid, 스페인, 28046
- 모병
- Hospital Universitario La Paz ( Site 1808)
-
연락하다:
- Study Coordinator
- 전화번호: +34917277516
-
Madrid, 스페인, 28007
- 모병
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)
-
연락하다:
- Study Coordinator
- 전화번호: +34915868115
-
Seville, 스페인, 41007
- 모병
- Hospital Universitario Virgen Macarena ( Site 1805)
-
연락하다:
- Study Coordinator
- 전화번호: +34955008000
-
-
Gerona
-
Girona, Gerona, 스페인, 17007
- 모병
- Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)
-
연락하다:
- Study Coordinator
- 전화번호: +34972225834
-
-
Valenciana, Comunitat
-
Valencia, Valenciana, Comunitat, 스페인, 46009
- 모병
- Fundación Instituto Valenciano de Oncología ( Site 1809)
-
연락하다:
- Study Coordinator
- 전화번호: +34961114230
-
-
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1430EGF
- 모병
- Clinica Adventista Belgrano ( Site 0304)
-
연락하다:
- Study Coordinator
- 전화번호: +541132682903
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1199ABB
- 모병
- Hospital Italiano de Buenos Aires. ( Site 0300)
-
연락하다:
- Study Coordinator
- 전화번호: +541149590200
-
Ciudad Autonoma de Buenos Aires., Buenos Aires, 아르헨티나, C1426ANZ
- 모병
- Instituto Alexander Fleming ( Site 0301)
-
연락하다:
- Study Coordinator
- 전화번호: +541132218900
-
Mar del Plata, Buenos Aires, 아르헨티나, B7600FZO
- 모병
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
-
연락하다:
- Study Coordinator
- 전화번호: +542234963223
-
-
Buenos Aires F.D.
-
Buenos Aires, Buenos Aires F.D., 아르헨티나, C1280AEB
- 모병
- Hospital Britanico de Buenos Aires ( Site 0305)
-
연락하다:
- Study Coordinator
- 전화번호: +541127698713
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, S2000DSV
- 모병
- Sanatorio Parque ( Site 0302)
-
연락하다:
- Study Coordinator
- 전화번호: 54 341 40200222
-
-
-
-
-
Cardiff, 영국, CF14 2TL
- 모병
- Velindre Cancer Centre ( Site 2104)
-
연락하다:
- Study Coordinator
- 전화번호: 029 2061 5888
-
Leeds, 영국, LS9 7TF
- 모병
- St James's University Hospital ( Site 2100)
-
연락하다:
- Study Coordinator
- 전화번호: +441132068436
-
-
-
-
-
Kyiv, 우크라이나, 03057
- 모병
- Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)
-
연락하다:
- Study Coordinator
- 전화번호: +380669472333
-
Kyiv, 우크라이나, 03680
- 모병
- Shalimov Institute of Surgery and Transplantation ( Site 2003)
-
연락하다:
- Study Coordinator
- 전화번호: +380933333911
-
-
Chernivetska Oblast
-
Chernivtsi, Chernivetska Oblast, 우크라이나, 58013
- 모병
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)
-
연락하다:
- Study Coordinator
- 전화번호: +380505144910
-
-
Dnipropetrovsk Oblast
-
Kryvyi Rih, Dnipropetrovsk Oblast, 우크라이나, 50000
- 모병
- Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)
-
연락하다:
- Study Coordinator
- 전화번호: +380973567855
-
-
Ivano-Frankivsk Oblast
-
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 우크라이나, 76018
- 모병
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)
-
연락하다:
- Study Coordinator
- 전화번호: +380342540325
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, 우크라이나, 25006
- 모병
- Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)
-
연락하다:
- Study Coordinator
- 전화번호: +380969680396
-
Kropyvnytskyi, Kirovohrad Oblast, 우크라이나, 25011
- 모병
- Ukrainian Center of Tomotherapy ( Site 2014)
-
연락하다:
- Study Coordinator
- 전화번호: +380676239652
-
-
Kyivska Oblast
-
Kyiv, Kyivska Oblast, 우크라이나, 03115
- 모병
- Kyiv City Clinical Oncology Center ( Site 2015)
-
연락하다:
- Study Coordinator
- 전화번호: +380672455533
-
-
Lviv Oblast
-
Lviv, Lviv Oblast, 우크라이나, 79031
- 모병
- Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)
-
연락하다:
- Study Coordinator
- 전화번호: +380975814015
-
Lviv, Lviv Oblast, 우크라이나, 79059
- 모병
- Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)
-
연락하다:
- Study Coordinator
- 전화번호: +380977453295
-
-
Odesa Oblast
-
Odesa, Odesa Oblast, 우크라이나, 65025
- 모병
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)
-
연락하다:
- Study Coordinator
- 전화번호: +380972147211
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, 우크라이나, 33010
- 모병
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)
-
연락하다:
- Study Coordinator
- 전화번호: +380971921000
-
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Vinnytsia Oblast
-
Vinnytsia, Vinnytsia Oblast, 우크라이나, 21029
- 모병
- Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)
-
연락하다:
- Study Coordinator
- 전화번호: +380432511160
-
-
Volyn Oblast
-
Lutsk, Volyn Oblast, 우크라이나, 43018
- 모병
- Volyn Regional Clinical Hospital ( Site 2010)
-
연락하다:
- Study Coordinator
- 전화번호: +380503782998
-
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-
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Emilia-Romagna
-
Meldola, Emilia-Romagna, 이탈리아, 47014
- 모병
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1403)
-
연락하다:
- Study Coordinator
- 전화번호: +390543739100
-
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Lazio
-
Rome, Lazio, 이탈리아, 00168
- 모병
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
-
연락하다:
- Study Coordinator
- 전화번호: +390630155202
-
Rome, Lazio, 이탈리아, 00144
- 모병
- Istituto Nazionale Tumori Regina Elena ( Site 1404)
-
연락하다:
- Study Coordinator
- 전화번호: +3906544289247
-
-
Lombardy
-
Milan, Lombardy, 이탈리아, 20133
- 모병
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)
-
연락하다:
- Study Coordinator
- 전화번호: +390223903831
-
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-
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Gunma
-
Ōta, Gunma, 일본, 373-8550
- 모병
- Gunma Prefectural Cancer Center ( Site 2302)
-
연락하다:
- Study Coordinator
- 전화번호: +81-276-38-0771
-
-
Hokkaido
-
Sapporo, Hokkaido, 일본, 003-0804
- 모병
- National Hospital Organization Hokkaido Cancer Center ( Site 2312)
-
연락하다:
- Study Coordinator
- 전화번호: +81-11-811-9111
-
-
Hyōgo
-
Kobe, Hyōgo, 일본, 650-0046
- 모병
- Kobe Minimally Invasive Cancer Center ( Site 2306)
-
연락하다:
- Study Coordinator
- 전화번호: +81-78-304-4100
-
-
Mie-ken
-
Matsusaka, Mie-ken, 일본, 515-8544
- 모병
- Saiseikai Matsusaka Municipal Hospital ( Site 2311)
-
연락하다:
- Study Coordinator
- 전화번호: +81-598-23-1515
-
-
Miyagi
-
Sendai, Miyagi, 일본, 981-0914
- 모병
- Sendai Kousei Hospital ( Site 2300)
-
연락하다:
- Study Coordinator
- 전화번호: +81-22-728-8000
-
-
Tochigi
-
Shimotsugagun, Tochigi, 일본, 321-0293
- 모병
- Dokkyo Medical University Hospital ( Site 2301)
-
연락하다:
- Study Coordinator
- 전화번호: +81-282-86-1111
-
-
-
-
Anhui
-
Hefei, Anhui, 중국, 230031
- 모병
- Anhui Provincial Cancer Hospital ( Site 2209)
-
연락하다:
- Study Coordinator
- 전화번호: +8655165327666
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100730
- 모병
- Beijing Peking Union Medical College Hospital ( Site 2220)
-
연락하다:
- Study Coordinator
- 전화번호: +8601069151188
-
Beijing, Beijing Municipality, 중국, 100142
- 모병
- Beijing Cancer hospital ( Site 2226)
-
연락하다:
- Study Coordinator
- 전화번호: +86 13901136511
-
Beijing, Beijing Municipality, 중국, 100142
- 모병
- Beijing Cancer hospital ( Site 2217)
-
연락하다:
- Study Coordinator
- 전화번호: 010-88196478
-
-
Fujian
-
Fuzhou, Fujian, 중국, 350014
- 모병
- Fujian Cancer Hospital ( Site 2232)
-
연락하다:
- Study Coordinator
- 전화번호: +8613809500871
-
Xiamen, Fujian, 중국, 361000
- 모병
- Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
-
연락하다:
- Study Coordinator
- 전화번호: +8613906036392
-
Xiamen, Fujian, 중국, 361003
- 모병
- The First Affiliated Hospital of Xiamen University. ( Site 2239)
-
연락하다:
- Study Coordinator
- 전화번호: +8613860458889
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510145
- 모병
- The First Affiliated Hospital of Guangzhou Medical University ( Site 2211)
-
연락하다:
- Study Coordinator
- 전화번호: 02083062338
-
-
Guangxi
-
Guilin, Guangxi, 중국, 541199
- 모병
- The Second Affiliated Hospital of Guilin Medical University ( Site 2212)
-
연락하다:
- Study Coordinator
- 전화번호: 07735590035
-
Nanning, Guangxi, 중국, 530022
- 모병
- Guangxi Medical University Cancer Hospital ( Site 2202)
-
연락하다:
- Study Coordinator
- 전화번호: +867715310045
-
-
Hebei
-
Shijiazhuang, Hebei, 중국, 050011
- 모병
- Fourth Hospital of Hebei Medical University ( Site 2201)
-
연락하다:
- Study Coordinator
- 전화번호: +8631166696241
-
-
Hubei
-
Wuhan, Hubei, 중국, 430048
- 모병
- Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)
-
연락하다:
- Study Coordinator
- 전화번호: +862783261400
-
Wuhan, Hubei, 중국, 430070
- 모병
- Hubei Cancer Hospital ( Site 2203)
-
연락하다:
- Study Coordinator
- 전화번호: +862787670275
-
-
Hunan
-
Changsha, Hunan, 중국, 410011
- 모병
- The Second Xiangya Hospital Of Central South University ( Site 2207)
-
연락하다:
- Study Coordinator
- 전화번호: 0731-85295888
-
Changsha, Hunan, 중국, 410013
- 모병
- Hunan Cancer Hospital ( Site 2214)
-
연락하다:
- Study Coordinator
- 전화번호: 0731-89761269
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210000
- 모병
- Nanjing Drum Tower Hospital ( Site 2224)
-
연락하다:
- Study Coordinator
- 전화번호: (86)025-83105910
-
-
Shandong
-
Jinan, Shandong, 중국, 250117
- 모병
- Shandong Cancer Hospital ( Site 2200)
-
연락하다:
- Study Coordinator
- 전화번호: +8613793150996
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200030
- 모병
- Zhongshan Hospital affiliated to Fudan University ( Site 2215)
-
연락하다:
- Study Coordinator
- 전화번호: +86 13621830381
-
Shanghai, Shanghai Municipality, 중국, 200032
- 모병
- Fudan University Shanghai Cancer Center ( Site 2216)
-
연락하다:
- Study Coordinator
- 전화번호: 8602138196379
-
Shanghai, Shanghai Municipality, 중국, 200030
- 모병
- Shanghai Chest Hospital ( Site 2229)
-
연락하다:
- Study Coordinator
- 전화번호: +8602122200000
-
-
Shanxi
-
Taiyuan, Shanxi, 중국, 030013
- 모병
- Shanxi Provincial Cancer Hospital ( Site 2227)
-
연락하다:
- Study Coordinator
- 전화번호: +863514881611
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610213
- 모병
- Sichuan Cancer hospital. ( Site 2218)
-
연락하다:
- Study Coordinator
- 전화번호: +8618227667677
-
Chengdu, Sichuan, 중국, 610041
- 모병
- West China Hospital, Sichuan University ( Site 2204)
-
연락하다:
- Study Coordinator
- 전화번호: +86 28 85422114
-
Chongqing, Sichuan, 중국, 400030
- 모병
- Chongqing University Cancer Hospital ( Site 2236)
-
연락하다:
- Study Coordinator
- 전화번호: 023-65456552
-
-
Xinjiang
-
Ürümqi, Xinjiang, 중국, 830000
- 모병
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2225)
-
연락하다:
- Study Coordinator
- 전화번호: +8609917968111
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310022
- 모병
- Zhejiang Cancer Hospital ( Site 2205)
-
연락하다:
- Study Coordinator
- 전화번호: 86057188122482
-
Linhai, Zhejiang, 중국, 317000
- 모병
- Taizhou Hospital of Zhejiang Province ( Site 2223)
-
연락하다:
- Study Coordinator
- 전화번호: 057685199810
-
Wenzhou, Zhejiang, 중국, 325000
- 모병
- The First Affiliated Hospital of Wenzhou Medical University ( Site 2235)
-
연락하다:
- Study Coordinator
- 전화번호: 0577-55578100
-
-
-
-
-
Adana, 터키 (Türkiye), 01140
- 모병
- Adana Medical Park Seyhan Hastanesi ( Site 1910)
-
연락하다:
- Study Coordinator
- 전화번호: 00904444484
-
Adana, 터키 (Türkiye), 01250
- 모병
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1903)
-
연락하다:
- Study Coordinator
- 전화번호: 905353067506
-
Ankara, 터키 (Türkiye), 06230
- 모병
- Hacettepe Universite Hastaneleri ( Site 1900)
-
연락하다:
- Study Coordinator
- 전화번호: +903123052841
-
Ankara, 터키 (Türkiye), 06680
- 모병
- Liv Hospital Ankara ( Site 1911)
-
연락하다:
- Study Coordinator
- 전화번호: +90 5520045315
-
Kayseri, 터키 (Türkiye), 38039
- 모병
- Erciyes University ( Site 1904)
-
연락하다:
- Study Coordinator
- 전화번호: +90 207 666 6270
-
Mersin, 터키 (Türkiye), 33240
- 모병
- Mersin Sehir Eğitim ve Araştırma Hastanesi. ( Site 1907)
-
연락하다:
- Study Coordinator
- 전화번호: 903242251000
-
Rize, 터키 (Türkiye), 53020
- 모병
- Recep Tayyip Erdogan University Training and Research Hospital ( Site 1908)
-
연락하다:
- Study Coordinator
- 전화번호: +905069939926
-
-
Ankara
-
Çankaya, Ankara, 터키 (Türkiye), 6800
- 모병
- Ankara Bilkent Şehir Hastanesi. ( Site 1906)
-
연락하다:
- Study Coordinator
- 전화번호: 903125526000
-
-
Istanbul
-
Kartal, Istanbul, 터키 (Türkiye), 34890
- 모병
- KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 1909)
-
연락하다:
- Study Coordinator
- 전화번호: +902164413900
-
-
-
-
Podkarpackie Voivodeship
-
Przemyśl, Podkarpackie Voivodeship, 폴란드, 37-700
- 모병
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602)
-
연락하다:
- Study Coordinator
- 전화번호: +48166775000
-
-
-
-
Gironde
-
Pessac, Gironde, 프랑스, 33600
- 모병
- CHU Bordeaux Haut-Leveque ( Site 1005)
-
연락하다:
- Study Coordinator
- 전화번호: +33556795679
-
-
Nord
-
Valenciennes, Nord, 프랑스, 59300
- 모병
- Clinique Teissier Groupe ( Site 1006)
-
연락하다:
- Study Coordinator
- 전화번호: +33327142434
-
-
-
-
New South Wales
-
Frenchs Forest, New South Wales, 호주, 2086
- 모병
- Northern Beaches Hospital ( Site 2401)
-
연락하다:
- Study Coordinator
- 전화번호: +61291055090
-
-
Queensland
-
South Brisbane, Queensland, 호주, 4101
- 모병
- Mater Misericordiae Limited ( Site 2402)
-
연락하다:
- Study Coordinator
- 전화번호: +61731762111
-
Woolloongabba, Queensland, 호주, 4102
- 모병
- Princess Alexandra Hospital ( Site 2406)
-
연락하다:
- Study Coordinator
- 전화번호: +61731766577
-
-
Victoria
-
Frankston, Victoria, 호주, 3199
- 모병
- Frankston Hospital ( Site 2403)
-
연락하다:
- Study Coordinator
- 전화번호: +61 3 9784 7777
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.
- Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.
- Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.
- Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.
- If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.
- If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.
- Has a body weight ≥35 kg.
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.
- Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Has received prior treatment (other than definitive CCRT) for NSCLC.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.
- Has an active infection requiring systemic therapy.
- Has a history of stem cell/solid organ transplant.
- Has not adequately recovered from major surgery or has ongoing surgical complications.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Calderasib + Durvalumab
Participants will receive calderasib and durvalumab. |
Tablet for oral administration.
다른 이름들:
Solution for intravenous (IV) infusion.
다른 이름들:
|
|
활성 비교기: Placebo + Durvalumab
Participants will receive placebo to calderasib and durvalumab. |
Solution for intravenous (IV) infusion.
다른 이름들:
Placebo to MK-1084. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Progression-Free Survival (PFS)
기간: Up to approximately 6 years
|
PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first. |
Up to approximately 6 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall Survival (OS)
기간: Up to approximately 9 years
|
OS is defined as the time from randomization to death due to any cause. |
Up to approximately 9 years
|
|
Number of Participants Who Experience an Adverse Events (AEs)
기간: Up to approximately 9 years
|
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented. |
Up to approximately 9 years
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
기간: Up to approximately 9 years
|
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented. |
Up to approximately 9 years
|
|
Objective Response Rate (ORR)
기간: Up to approximately 9 years
|
ORR is defined as the percentage of participants with Complete Response (CR) or Partial Response (PR) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented. |
Up to approximately 9 years
|
|
Duration of Response (DOR)
기간: Up to approximately 9 years
|
For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. |
Up to approximately 9 years
|
|
Distant Metastasis-Free Survival (DMFS)
기간: Up to approximately 9 years
|
DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread beyond the original (primary) tumor/regional metastases to distant organs or distant lymph nodes. |
Up to approximately 9 years
|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (GHS)/Quality of Life (QoL) (Items 29 & 30) Combined Score
기간: Baseline and up to approximately 9 years
|
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in GHS and QoL combined score will be presented. |
Baseline and up to approximately 9 years
|
|
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Combined Score
기간: Baseline and up to approximately 9 years
|
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented. |
Baseline and up to approximately 9 years
|
|
Change from Baseline in Role Functioning (EORTC QLQ-C30 Items 6 & 7) Combined Score
기간: Baseline and up to approximately 9 years
|
The EORTC QLQ-C30 is a cancer specific health-related quality of life questionnaire. The role functioning score is based on participant responses to questions scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score was computed by averaging the raw scores of Items 6 and 7 and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate better role functioning. The change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) combined score will be reported. |
Baseline and up to approximately 9 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Medical Director, Merck Sharp & Dohme LLC
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 18일
기본 완료 (추정된)
2032년 12월 15일
연구 완료 (추정된)
2037년 8월 17일
연구 등록 날짜
최초 제출
2026년 4월 21일
QC 기준을 충족하는 최초 제출
2026년 4월 21일
처음 게시됨 (실제)
2026년 4월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 11월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 11월 11일
마지막으로 확인됨
2026년 11월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1084-015
- 2025-522038-29-00 (레지스트리 식별자: EU CT)
- U1111-1321-6971 (레지스트리 식별자: UTN)
- MK-1084-015 (기타 식별자: MSD)
- KANDLELIT-015 (기타 식별자: MSD)
- jRCT2021260021 (레지스트리 식별자: jRCT)
- 2025 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
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