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RECRUITING
NCT07554339
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Calderasib

Tablet for oral administration.

BIOLOGICAL

Durvalumab

Solution for intravenous (IV) infusion.

OTHER

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