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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
2026-06-26
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 (16)
NHO Revive Research Institute LLC ( Site 0118)
Lincoln, Nebraska, United States
Ajou University Hospital ( Site 2504)
Suwon, Kyonggi-do, 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
National Cheng Kung University Hospital ( Site 2601)
Tainan, 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
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