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MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Sponsor: Merck Sharp & Dohme LLC
Summary
This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.
Official title: A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2026-03-18
Completion Date
2039-10-26
Last Updated
2026-05-11
Healthy Volunteers
No
Conditions
Interventions
Calderasib
MK-1084 oral tablet
MK-3475A
Fixed dose coformulated product of hyaluronidase/pembrolizumab administered via SC injection.
Placebo
Placebo oral tablet
Locations (24)
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0309)
CABA, Argentina
Guangxi Medical University Cancer Hospital ( Site 2115)
Nanning, Guangxi, China
Sichuan Cancer hospital ( Site 2101)
Chengdu, Sichuan, China
The Third Peoples Hospital Of Chengdu ( Site 2141)
Chengdu, Sichuan, China
Queen Mary Hospital ( Site 3100)
Hong Kong, Hong Kong
National Cancer Center ( Site 3603)
Goyang-si, Kyonggi-do, South Korea
Keimyung University Dongsan Hospital ( Site 3605)
Daegu, Taegu-Kwangyokshi, South Korea
Severance Hospital Yonsei University Health System ( Site 3601)
Seoul, South Korea
Asan Medical Center ( Site 3600)
Seoul, South Korea
National Cheng Kung University Hospital ( Site 3706)
Tainan, Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 1904)
Cherkasy, Cherkasy Oblast, Ukraine
Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1909)
Chernivtsi, Chernivetska Oblast, Ukraine
Medical Center "Mriya Med-Service" ( Site 1911)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Communal Non-Commercial Enterprise Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regio ( Site 1900)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Private Enterprise Private Manufacturing Company Acinus-Medical and Diagnostic Centre ( Site 1916)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Ukrainian Center of Tomotherapy ( Site 1917)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Communal noncommercial enterprise of Lviv regional council "Lviv oncological regional therapeutical ( Site 1908)
Lviv, Lviv Oblast, Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 1902)
Lviv, Lviv Oblast, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 1913)
Odesa, Odesa Oblast, Ukraine
ME "Rivne Regional Antitumor Center" Rivne Regional Council ( Site 1912)
Rivne, Rivne Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 1903)
Vinnytsia, Vinnytsia Oblast, Ukraine
Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council ( Site 1914)
Lutsk, Volyn Oblast, Ukraine
Medical Center "Universal Clinic "Oberig" of Limited Liability Company "Kapytal" ( Site 1915)
Kyiv, Ukraine
Shalimov Institute of Surgery and Transplantation ( Site 1907)
Kyiv, Ukraine