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KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers want to learn if using a study medicine called MK-1084 can help treat NSCLC. MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.
Official title: KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2025-12-19
Completion Date
2033-01-14
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
MK-1084
Oral Administration
Pembrolizumab
Intravenous administration
Cetuximab
Intravenous administration
Carboplatin
Intravenous administration
Pemetrexed
Intravenous administration
Locations (15)
Clermont Oncology Center ( Site 0041)
Clermont, Florida, United States
HYKS Syöpätautien klinikka ( Site 0260)
Helsinki, Uusimaa, Finland
Deventer Ziekenhuis ( Site 0272)
Deventer, Overijssel, Netherlands
Leids Universitair Medisch Centrum ( Site 0273)
Leiden, South Holland, Netherlands
Severance Hospital Yonsei University Health System ( Site 0080)
Seoul, South Korea
Hacettepe Universite Hastaneleri ( Site 0140)
Ankara, Turkey (Türkiye)
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)
Cherkasy, Cherkasy Oblast, Ukraine
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)
Lviv, Lviv Oblast, Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)
Vinnitsya, Vinnytsia Oblast, Ukraine
Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)
Uzhhorod, Zakarpattia Oblast, Ukraine
VISION PARTNER Medical Centre ( Site 0135)
Kyiv, Ukraine
LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)
Kyiv, Ukraine