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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
2026-08-07
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 (53)
NHO Revive Research Institute LLC ( Site 0118)
Lincoln, Nebraska, United States
New York Oncology Hematology P.C ( Site 9000)
Albany, New York, United States
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
Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)
Xiamen, Fujian, China
The First Affiliated Hospital of Xiamen University. ( Site 2239)
Xiamen, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 2202)
Qingxiu District, Guangxi, 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
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
Shanxi Provincial Cancer Hospital ( Site 2227)
Taiyuan, Shanxi, China
Sichuan Cancer hospital. ( Site 2218)
Chengdu, Sichuan, China
Gemeinschaftspraxis für Hämatologie und Onkologie Münster ( Site 1108)
Münster, North Rhine-Westphalia, Germany
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1401)
Rome, Lazio, Italy
Radboudumc ( Site 1504)
Nijmegen, Gelderland, Netherlands
Leids Universitair Medisch Centrum ( Site 1503)
Leiden, South Holland, Netherlands
University Medical Center Groningen ( Site 1505)
Groningen, Netherlands
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 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
Tri-Service General Hospital ( Site 2608)
Taipei, Taiwan
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
Shalimov Institute of Surgery and Transplantation ( Site 2003)
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
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2001)
Rivne, Rivne Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 2004)
Vinnytsia, Vinnytsia Oblast, Ukraine
Volyn Regional Clinical Hospital ( Site 2010)
Lutsk, Volyn Oblast, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 2005)
Kyiv, Ukraine