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A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
310
Start Date
2026-06-18
Completion Date
2037-08-17
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Calderasib
Tablet for oral administration.
Durvalumab
Solution for intravenous (IV) infusion.
Placebo to MK-1084
Placebo to MK-1084.
Locations (107)
Low Country Cancer Care ( Site 0155)
Savannah, Georgia, United States
Duly Healthcare ( Site 0158)
Lisle, Illinois, United States
NHO Revive Research Institute LLC ( Site 0118)
Lincoln, Nebraska, United States
New York Oncology Hematology P.C ( Site 9000)
Albany, New York, United States
WakeMed Raleigh Campus ( Site 0144)
Raleigh, North Carolina, United States
Virginia Cancer Specialists ( Site 0114)
Fairfax, Virginia, United States
Instituto Alexander Fleming ( Site 0301)
Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentina
Hospital Italiano de Buenos Aires. ( Site 0300)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Clinica Adventista Belgrano ( Site 0304)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)
Mar del Plata, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires ( Site 0305)
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 0302)
Rosario, Santa Fe Province, Argentina
Northern Beaches Hospital ( Site 2401)
Frenchs Forest, New South Wales, Australia
Mater Misericordiae Limited ( Site 2402)
South Brisbane, Queensland, Australia
Princess Alexandra Hospital ( Site 2406)
Woolloongabba, Queensland, Australia
Frankston Hospital ( Site 2403)
Frankston, Victoria, Australia
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406)
Fortaleza, Ceará, Brazil
AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)
Vitória, Espírito Santo, Brazil
CEPON ( Site 0413)
Florianópolis, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)
Barretos, São Paulo, Brazil
Anhui Provincial Cancer Hospital ( Site 2209)
Hefei, Anhui, China
Beijing Cancer hospital ( Site 2226)
Beijing, Beijing Municipality, China
Beijing Peking Union Medical College Hospital ( Site 2220)
Beijing, Beijing Municipality, China
Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University. ( Site 2239)
Xiamen, Fujian, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 2211)
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guilin Medical University ( Site 2212)
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital ( Site 2202)
Nanning, Guangxi, China
Fourth Hospital of Hebei Medical University ( Site 2201)
Shijiazhuang, Hebei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)
Wuhan, Hubei, China
Hubei Cancer Hospital ( Site 2203)
Wuhan, Hubei, China
The Second Xiangya Hospital Of Central South University ( Site 2207)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 2214)
Changsha, Hunan, China
Nanjing Drum Tower Hospital ( Site 2224)
Nanjing, Jiangsu, China
Shandong Cancer Hospital ( Site 2200)
Jinan, Shandong, China
Zhongshan Hospital affiliated to Fudan University ( Site 2215)
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center ( Site 2216)
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital ( Site 2227)
Taiyuan, Shanxi, China
Sichuan Cancer hospital. ( Site 2218)
Chengdu, Sichuan, China
Chongqing University Cancer Hospital ( Site 2236)
Chongqing, Sichuan, China
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2225)
Ürümqi, Xinjiang, China
Taizhou Hospital of Zhejiang Province ( Site 2223)
Linhai, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 2235)
Wenzhou, Zhejiang, China
Clinique Teissier Groupe ( Site 1006)
Valenciennes, Nord, France
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
Münster, North Rhine-Westphalia, Germany
Katholisches Marienkrankenhaus gGmbH ( Site 1101)
Hamburg, Germany
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 1205)
Athens, Attica, Greece
ALEXANDRA General Hospital of Athens ( Site 1200)
Athens, Attica, Greece
Athens Medical Center ( Site 1201)
Athens, Attica, Greece
Metaxa Cancer Hospital of Piraeus ( Site 1203)
Piraeus, Attica, Greece
University General Hospital of Alexandroupoli ( Site 1206)
Alexandroupoli, East Macedonia and Thrace, Greece
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1403)
Meldola, Emilia-Romagna, Italy
Istituto Nazionale Tumori Regina Elena ( Site 1404)
Rome, Lazio, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1400)
Milan, Lombardy, Italy
National Hospital Organization Hokkaido Cancer Center ( Site 2312)
Sapporo, Hokkaido, Japan
Kobe Minimally Invasive Cancer Center ( Site 2306)
Kobe, Hyōgo, Japan
Saiseikai Matsusaka Municipal Hospital ( Site 2311)
Matsusaka, Mie-ken, Japan
Sendai Kousei Hospital ( Site 2300)
Sendai, Miyagi, Japan
Radboudumc ( Site 1504)
Nijmegen, Gelderland, Netherlands
Ziekenhuis Groep Twente, locatie Hengelo ( Site 1500)
Hengelo, Overijssel, Netherlands
Leids Universitair Medisch Centrum ( Site 1503)
Leiden, South Holland, Netherlands
University Medical Center Groningen ( Site 1505)
Groningen, Netherlands
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1602)
Przemyśl, Podkarpackie Voivodeship, Poland
National Cancer Center ( Site 2505)
Goyang-si, Kyonggi-do, South Korea
Ajou University Hospital ( Site 2504)
Suwon, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 2502)
Cheongju-si, North Chungcheong, South Korea
Keimyung University Dongsan Hospital ( Site 2503)
Daegu, Taegu-Kwangyokshi, South Korea
Severance Hospital, Yonsei University Health System ( Site 2501)
Seoul, South Korea
Asan Medical Center ( Site 2500)
Seoul, South Korea
Institut Català d'Oncologia (ICO) - Girona-Oncología Médica ( Site 1807)
Girona, Gerona, Spain
Fundación Instituto Valenciano de Oncología ( Site 1809)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron ( Site 1800)
Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1803)
Madrid, Spain
Hospital Clinico San Carlos ( Site 1810)
Madrid, Spain
Hospital Universitario La Paz ( Site 1808)
Madrid, Spain
Hospital Universitario Virgen Macarena ( Site 1805)
Seville, Spain
Taipei Medical University Shuang Ho Hospital ( Site 2612)
New Taipei City, Taiwan
National Cheng Kung University Hospital ( Site 2601)
Tainan, Taiwan
Mackay Memorial Hospital ( Site 2611)
Taipei, Taiwan
National Taiwan University Cancer Center (NTUCC) ( Site 2610)
Taipei, Taiwan
Tri-Service General Hospital ( Site 2608)
Taipei, Taiwan
Ankara Bilkent Şehir Hastanesi. ( Site 1906)
Çankaya, Ankara, Turkey (Türkiye)
KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 1909)
Kartal, Istanbul, Turkey (Türkiye)
Adana Medical Park Seyhan Hastanesi ( Site 1910)
Adana, Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1903)
Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1900)
Ankara, Turkey (Türkiye)
Liv Hospital Ankara ( Site 1911)
Ankara, Turkey (Türkiye)
Erciyes University ( Site 1904)
Kayseri, Turkey (Türkiye)
Mersin Sehir Eğitim ve Araştırma Hastanesi. ( Site 1907)
Mersin, Turkey (Türkiye)
Recep Tayyip Erdogan University Training and Research Hospital ( Site 1908)
Rize, Turkey (Türkiye)
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 2002)
Chernivtsi, Chernivetska Oblast, Ukraine
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 2012)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 2006)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 2013)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 2014)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 2015)
Kyiv, Kyivska Oblast, Ukraine
Lviv Oncology Regional Treatment and Diagnostic Center ( Site 2009)
Lviv, Lviv Oblast, Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 2000)
Lviv, Lviv Oblast, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2011)
Odesa, Odesa Oblast, Ukraine