A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
29. oktober 2026 opdateret af: Merck Sharp & Dohme LLC
Et fase 3, randomiseret, dobbeltblindt, placebo- og aktivkomparator-kontrolleret studie af MK-1084 plus durvalumab versus placebo plus durvalumab hos deltagere med lokalt fremskreden, ikke-opererbar KRAS G12C-mutant ikke-småcellet lungekræft uden sygdomsprogression efter definitiv platinbaseret kemoradioterapi (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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
310
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-mail: Trialsites@msd.com
Studiesteder
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1430EGF
- Rekruttering
- Clinica Adventista Belgrano ( Site 0304)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541132682903
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
- Rekruttering
- Hospital Italiano de Buenos Aires. ( Site 0300)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541149590200
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Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina, C1426ANZ
- Rekruttering
- Instituto Alexander Fleming ( Site 0301)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541132218900
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Mar del Plata, Buenos Aires, Argentina, B7600FZO
- Rekruttering
- Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
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Kontakt:
- Study Coordinator
- Telefonnummer: +542234963223
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Buenos Aires F.D.
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Buenos Aires, Buenos Aires F.D., Argentina, C1280AEB
- Rekruttering
- Hospital Britanico de Buenos Aires ( Site 0305)
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Kontakt:
- Study Coordinator
- Telefonnummer: +541127698713
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DSV
- Rekruttering
- Sanatorio Parque ( Site 0302)
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Kontakt:
- Study Coordinator
- Telefonnummer: 54 341 40200222
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New South Wales
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Frenchs Forest, New South Wales, Australien, 2086
- Rekruttering
- Northern Beaches Hospital ( Site 2401)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61291055090
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Rekruttering
- Mater Misericordiae Limited ( Site 2402)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61731762111
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Woolloongabba, Queensland, Australien, 4102
- Rekruttering
- Princess Alexandra Hospital ( Site 2406)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61731766577
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Victoria
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Frankston, Victoria, Australien, 3199
- Rekruttering
- Frankston Hospital ( Site 2403)
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Kontakt:
- Study Coordinator
- Telefonnummer: +61 3 9784 7777
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Ceará
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Fortaleza, Ceará, Brasilien, 60336-232
- Rekruttering
- CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406)
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Kontakt:
- Study Coordinator
- Telefonnummer: +55 85 32865934
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Espírito Santo
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Vitória, Espírito Santo, Brasilien, 29043-260
- Rekruttering
- AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)
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Kontakt:
- Study Coordinator
- Telefonnummer: +5527998469004
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Santa Catarina
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Florianópolis, Santa Catarina, Brasilien, 88034-000
- Rekruttering
- CEPON ( Site 0413)
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Kontakt:
- Study Coordinator
- Telefonnummer: +554833311553
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São Paulo
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Barretos, São Paulo, Brasilien, 14784-400
- Rekruttering
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)
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Kontakt:
- Study Coordinator
- Telefonnummer: +551733216638
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Cardiff, Det Forenede Kongerige, CF14 2TL
- Rekruttering
- Velindre Cancer Centre ( Site 2104)
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Kontakt:
- Study Coordinator
- Telefonnummer: 029 2061 5888
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Leeds, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- St James's University Hospital ( Site 2100)
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Kontakt:
- Study Coordinator
- Telefonnummer: +441132068436
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Georgia
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Savannah, Georgia, Forenede Stater, 31404
- Rekruttering
- Low Country Cancer Care ( Site 0155)
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Kontakt:
- Study Coordinator
- Telefonnummer: 912-692-2000
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Illinois
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Lisle, Illinois, Forenede Stater, 60532
- Rekruttering
- Duly Healthcare ( Site 0158)
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Kontakt:
- Study Coordinator
- Telefonnummer: 630-545-7760
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Nebraska
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Lincoln, Nebraska, Forenede Stater, 68506
- Rekruttering
- NHO Revive Research Institute LLC ( Site 0118)
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Kontakt:
- Study Coordinator
- Telefonnummer: 402-484-4900
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New York
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Albany, New York, Forenede Stater, 12206
- Rekruttering
- New York Oncology Hematology P.C ( Site 9000)
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Kontakt:
- Study Coordinator
- Telefonnummer: 518-489-0044
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North Carolina
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Raleigh, North Carolina, Forenede Stater, 27610
- Rekruttering
- WakeMed Raleigh Campus ( Site 0144)
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Kontakt:
- Study Coordinator
- Telefonnummer: 919-350-2873
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Rekruttering
- Virginia Cancer Specialists ( Site 0114)
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Kontakt:
- Study Coordinator
- Telefonnummer: 703-208-3110
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Nord
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Valenciennes, Nord, Frankrig, 59300
- Rekruttering
- Clinique Teissier Groupe ( Site 1006)
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Kontakt:
- Study Coordinator
- Telefonnummer: +33327142434
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Attica
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Athens, Attica, Grækenland, 151 25
- Rekruttering
- Athens Medical Center ( Site 1201)
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Kontakt:
- Study Coordinator
- Telefonnummer: +306986817837
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Athens, Attica, Grækenland, 115 28
- Rekruttering
- ALEXANDRA General Hospital of Athens ( Site 1200)
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Kontakt:
- Study Coordinator
- Telefonnummer: +306934137080
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Athens, Attica, Grækenland, 115 27
- Rekruttering
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1205)
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Kontakt:
- Study Coordinator
- Telefonnummer: +302107700220
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Piraeus, Attica, Grækenland, 185 37
- Rekruttering
- Metaxa Cancer Hospital of Piraeus ( Site 1203)
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Kontakt:
- Study Coordinator
- Telefonnummer: +306940583449
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East Macedonia and Thrace
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Alexandroupoli, East Macedonia and Thrace, Grækenland, 681 00
- Rekruttering
- University General Hospital of Alexandroupoli ( Site 1206)
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Kontakt:
- Study Coordinator
- Telefonnummer: +306973489404
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Groningen, Holland, 9713 GZ
- Rekruttering
- University Medical Center Groningen ( Site 1505)
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Kontakt:
- Study Coordinator
- Telefonnummer: +31503614679
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Gelderland
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Nijmegen, Gelderland, Holland, 6525 GA
- Rekruttering
- Radboudumc ( Site 1504)
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Kontakt:
- Study Coordinator
- Telefonnummer: + 31243610353
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Overijssel
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Hengelo, Overijssel, Holland, 7555 DL
- Rekruttering
- Ziekenhuis Groep Twente, locatie Hengelo ( Site 1500)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0031887083454
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South Holland
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Leiden, South Holland, Holland, 2333 ZA
- Rekruttering
- Leids Universitair Medisch Centrum ( Site 1503)
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Kontakt:
- Study Coordinator
- Telefonnummer: +31715566376
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italien, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1403)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390543739100
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Lazio
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Rome, Lazio, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390630155202
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Rome, Lazio, Italien, 00144
- Rekruttering
- Istituto Nazionale Tumori Regina Elena ( Site 1404)
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Kontakt:
- Study Coordinator
- Telefonnummer: +3906544289247
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Lombardy
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Milan, Lombardy, Italien, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)
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Kontakt:
- Study Coordinator
- Telefonnummer: +390223903831
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Hokkaido
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Sapporo, Hokkaido, Japan, 003-0804
- Rekruttering
- National Hospital Organization Hokkaido Cancer Center ( Site 2312)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-11-811-9111
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Hyōgo
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Kobe, Hyōgo, Japan, 650-0046
- Rekruttering
- Kobe Minimally Invasive Cancer Center ( Site 2306)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-78-304-4100
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Mie-ken
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Matsusaka, Mie-ken, Japan, 515-8544
- Rekruttering
- Saiseikai Matsusaka Municipal Hospital ( Site 2311)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-598-23-1515
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Miyagi
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Sendai, Miyagi, Japan, 981-0914
- Rekruttering
- Sendai Kousei Hospital ( Site 2300)
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Kontakt:
- Study Coordinator
- Telefonnummer: +81-22-728-8000
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Anhui
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Hefei, Anhui, Kina, 230031
- Rekruttering
- Anhui Provincial Cancer Hospital ( Site 2209)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8655165327666
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Beijing Peking Union Medical College Hospital ( Site 2220)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8601069151188
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Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital ( Site 2226)
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Kontakt:
- Study Coordinator
- Telefonnummer: +86 13901136511
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Fujian
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Xiamen, Fujian, Kina, 361000
- Rekruttering
- Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8613906036392
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Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated Hospital of Xiamen University. ( Site 2239)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8613860458889
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Guangdong
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Guangzhou, Guangdong, Kina, 510145
- Rekruttering
- The First Affiliated Hospital of Guangzhou Medical University ( Site 2211)
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Kontakt:
- Study Coordinator
- Telefonnummer: 02083062338
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Guangxi
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Guilin, Guangxi, Kina, 541199
- Rekruttering
- The Second Affiliated Hospital of Guilin Medical University ( Site 2212)
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Kontakt:
- Study Coordinator
- Telefonnummer: 07735590035
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Nanning, Guangxi, Kina, 530022
- Rekruttering
- Guangxi Medical University Cancer Hospital ( Site 2202)
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Kontakt:
- Study Coordinator
- Telefonnummer: +867715310045
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Hebei
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Shijiazhuang, Hebei, Kina, 050011
- Rekruttering
- Fourth Hospital of Hebei Medical University ( Site 2201)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8631166696241
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Hubei
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Wuhan, Hubei, Kina, 430048
- Rekruttering
- Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)
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Kontakt:
- Study Coordinator
- Telefonnummer: +862783261400
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Wuhan, Hubei, Kina, 430070
- Rekruttering
- Hubei Cancer Hospital ( Site 2203)
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Kontakt:
- Study Coordinator
- Telefonnummer: +862787670275
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Hunan
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Changsha, Hunan, Kina, 410011
- Rekruttering
- The Second Xiangya Hospital Of Central South University ( Site 2207)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0731-85295888
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Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital ( Site 2214)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0731-89761269
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Jiangsu
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Nanjing, Jiangsu, Kina, 210000
- Rekruttering
- Nanjing Drum Tower Hospital ( Site 2224)
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Kontakt:
- Study Coordinator
- Telefonnummer: (86)025-83105910
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Shandong
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Jinan, Shandong, Kina, 250117
- Rekruttering
- Shandong Cancer Hospital ( Site 2200)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8613793150996
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200030
- Rekruttering
- Zhongshan Hospital affiliated to Fudan University ( Site 2215)
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Kontakt:
- Study Coordinator
- Telefonnummer: +86 13621830381
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Shanghai, Shanghai Municipality, Kina, 200032
- Rekruttering
- Fudan University Shanghai Cancer Center ( Site 2216)
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Kontakt:
- Study Coordinator
- Telefonnummer: 8602138196379
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Shanxi
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Taiyuan, Shanxi, Kina, 030013
- Rekruttering
- Shanxi Provincial Cancer Hospital ( Site 2227)
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Kontakt:
- Study Coordinator
- Telefonnummer: +863514881611
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Sichuan
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Chengdu, Sichuan, Kina, 610213
- Rekruttering
- Sichuan Cancer hospital. ( Site 2218)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8618227667677
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Chongqing, Sichuan, Kina, 400030
- Rekruttering
- Chongqing University Cancer Hospital ( Site 2236)
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Kontakt:
- Study Coordinator
- Telefonnummer: 023-65456552
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Xinjiang
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Ürümqi, Xinjiang, Kina, 830000
- Rekruttering
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2225)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8609917968111
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Zhejiang
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Linhai, Zhejiang, Kina, 317000
- Rekruttering
- Taizhou Hospital of Zhejiang Province ( Site 2223)
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Kontakt:
- Study Coordinator
- Telefonnummer: 057685199810
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Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University ( Site 2235)
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Kontakt:
- Study Coordinator
- Telefonnummer: 0577-55578100
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Podkarpackie Voivodeship
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Przemyśl, Podkarpackie Voivodeship, Polen, 37-700
- Rekruttering
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602)
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Kontakt:
- Study Coordinator
- Telefonnummer: +48166775000
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Barcelona, Spanien, 08035
- Rekruttering
- Hospital Universitari Vall d'Hebron ( Site 1800)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34932746000
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Madrid, Spanien, 28040
- Rekruttering
- Hospital Clinico San Carlos ( Site 1810)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34913303000x484835
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Madrid, Spanien, 28046
- Rekruttering
- Hospital Universitario La Paz ( Site 1808)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34917277516
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Madrid, Spanien, 28007
- Rekruttering
- HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34915868115
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Seville, Spanien, 41007
- Rekruttering
- Hospital Universitario Virgen Macarena ( Site 1805)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34955008000
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Gerona
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Girona, Gerona, Spanien, 17007
- Rekruttering
- Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34972225834
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Valenciana, Comunitat
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Valencia, Valenciana, Comunitat, Spanien, 46009
- Rekruttering
- Fundación Instituto Valenciano de Oncología ( Site 1809)
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Kontakt:
- Study Coordinator
- Telefonnummer: +34961114230
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Seoul, Sydkorea, 03722
- Rekruttering
- Severance Hospital, Yonsei University Health System ( Site 2501)
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Kontakt:
- Study Coordinator
- Telefonnummer: 82-2-2228-0831
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Seoul, Sydkorea, 05505
- Rekruttering
- Asan Medical Center ( Site 2500)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82230103214
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Kyonggi-do
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Goyang-si, Kyonggi-do, Sydkorea, 10408
- Rekruttering
- National Cancer Center ( Site 2505)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82319201694
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Suwon, Kyonggi-do, Sydkorea, 16499
- Rekruttering
- Ajou University Hospital ( Site 2504)
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Kontakt:
- Study Coordinator
- Telefonnummer: +8216886114
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North Chungcheong
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Cheongju-si, North Chungcheong, Sydkorea, 28644
- Rekruttering
- Chungbuk National University Hospital ( Site 2502)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82432696015
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Taegu-Kwangyokshi
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Daegu, Taegu-Kwangyokshi, Sydkorea, 42601
- Rekruttering
- Keimyung University Dongsan Hospital ( Site 2503)
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Kontakt:
- Study Coordinator
- Telefonnummer: +82532586671
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New Taipei City, Taiwan, 23561
- Rekruttering
- Taipei Medical University Shuang Ho Hospital ( Site 2612)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886-970-747-515
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Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital ( Site 2601)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886-6-2353535#3120
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Taipei, Taiwan, 10449
- Rekruttering
- Mackay Memorial Hospital ( Site 2611)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886-2543-3535
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Taipei, Taiwan, 114
- Rekruttering
- Tri-Service General Hospital ( Site 2608)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886287923311
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Taipei, Taiwan, 106
- Rekruttering
- National Taiwan University Cancer Center (NTUCC) ( Site 2610)
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Kontakt:
- Study Coordinator
- Telefonnummer: +886-2-2312-3456
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Adana, Tyrkiet (Türkiye), 01140
- Rekruttering
- Adana Medical Park Seyhan Hastanesi ( Site 1910)
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Kontakt:
- Study Coordinator
- Telefonnummer: 00904444484
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Adana, Tyrkiet (Türkiye), 01250
- Rekruttering
- Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1903)
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Kontakt:
- Study Coordinator
- Telefonnummer: 905353067506
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Ankara, Tyrkiet (Türkiye), 06230
- Rekruttering
- Hacettepe Universite Hastaneleri ( Site 1900)
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Kontakt:
- Study Coordinator
- Telefonnummer: +903123052841
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Ankara, Tyrkiet (Türkiye), 06680
- Rekruttering
- Liv Hospital Ankara ( Site 1911)
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Kontakt:
- Study Coordinator
- Telefonnummer: +90 5520045315
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Kayseri, Tyrkiet (Türkiye), 38039
- Rekruttering
- Erciyes University ( Site 1904)
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Kontakt:
- Study Coordinator
- Telefonnummer: +90 207 666 6270
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Mersin, Tyrkiet (Türkiye), 33240
- Rekruttering
- Mersin Sehir Eğitim ve Araştırma Hastanesi. ( Site 1907)
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Kontakt:
- Study Coordinator
- Telefonnummer: 903242251000
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Rize, Tyrkiet (Türkiye), 53020
- Rekruttering
- Recep Tayyip Erdogan University Training and Research Hospital ( Site 1908)
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Kontakt:
- Study Coordinator
- Telefonnummer: +905069939926
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Ankara
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Çankaya, Ankara, Tyrkiet (Türkiye), 6800
- Rekruttering
- Ankara Bilkent Şehir Hastanesi. ( Site 1906)
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Kontakt:
- Study Coordinator
- Telefonnummer: 903125526000
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Istanbul
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Kartal, Istanbul, Tyrkiet (Türkiye), 34890
- Rekruttering
- KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 1909)
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Kontakt:
- Study Coordinator
- Telefonnummer: +902164413900
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Hamburg, Tyskland, 22087
- Rekruttering
- Katholisches Marienkrankenhaus gGmbH ( Site 1101)
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Kontakt:
- Study Coordinator
- Telefonnummer: +494025460
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Tyskland, 48153
- Rekruttering
- Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
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Kontakt:
- Study Coordinator
- Telefonnummer: +492519764537
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Kyiv, Ukraine, 03057
- Rekruttering
- Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)
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Kontakt:
- Study Coordinator
- Telefonnummer: +380669472333
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Kyiv, Ukraine, 03680
- Rekruttering
- Shalimov Institute of Surgery and Transplantation ( Site 2003)
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Kontakt:
- Study Coordinator
- Telefonnummer: +380933333911
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Chernivetska Oblast
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Chernivtsi, Chernivetska Oblast, Ukraine, 58013
- Rekruttering
- Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)
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Kontakt:
- Study Coordinator
- Telefonnummer: +380505144910
-
-
Dnipropetrovsk Oblast
-
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
- Rekruttering
- Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380973567855
-
-
Ivano-Frankivsk Oblast
-
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
- Rekruttering
- Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380342540325
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25006
- Rekruttering
- Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380969680396
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
- Rekruttering
- Ukrainian Center of Tomotherapy ( Site 2014)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380676239652
-
-
Kyivska Oblast
-
Kyiv, Kyivska Oblast, Ukraine, 03115
- Rekruttering
- Kyiv City Clinical Oncology Center ( Site 2015)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380672455533
-
-
Lviv Oblast
-
Lviv, Lviv Oblast, Ukraine, 79031
- Rekruttering
- Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380975814015
-
Lviv, Lviv Oblast, Ukraine, 79059
- Rekruttering
- Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380977453295
-
-
Odesa Oblast
-
Odesa, Odesa Oblast, Ukraine, 65025
- Rekruttering
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380972147211
-
-
Rivne Oblast
-
Rivne, Rivne Oblast, Ukraine, 33010
- Rekruttering
- ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380971921000
-
-
Vinnytsia Oblast
-
Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
- Rekruttering
- Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380432511160
-
-
Volyn Oblast
-
Lutsk, Volyn Oblast, Ukraine, 43018
- Rekruttering
- Volyn Regional Clinical Hospital ( Site 2010)
-
Kontakt:
- Study Coordinator
- Telefonnummer: +380503782998
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Calderasib + Durvalumab
Participants will receive calderasib and durvalumab. |
Tablet for oral administration.
Andre navne:
Solution for intravenous (IV) infusion.
Andre navne:
|
|
Aktiv komparator: Placebo + Durvalumab
Participants will receive placebo to calderasib and durvalumab. |
Solution for intravenous (IV) infusion.
Andre navne:
Placebo to MK-1084. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. juni 2026
Primær færdiggørelse (Anslået)
15. december 2032
Studieafslutning (Anslået)
17. august 2037
Datoer for studieregistrering
Først indsendt
21. april 2026
Først indsendt, der opfyldte QC-kriterier
21. april 2026
Først opslået (Faktiske)
28. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. oktober 2026
Sidst verificeret
1. oktober 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1084-015
- 2025-522038-29-00 (Registry Identifier: EU CT)
- U1111-1321-6971 (Registry Identifier: UTN)
- MK-1084-015 (Anden identifikator: MSD)
- KANDLELIT-015 (Anden identifikator: MSD)
- jRCT2021260021 (Registry Identifier: jRCT)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .