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)
Start Date
12/19/2025
Completion Date
1/14/2033
Summary
Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
MK-1084
Pembrolizumab
Cetuximab
Sacituzumab tirumotecan (sac-TMT)
Rescue medication
Conditions
Locations
Clermont Oncology Center ( Site 0041)
Clermont, Florida 34711
United States
Sanford Health Roger Maris Cancer Center ( Site 0039)
Fargo, North Dakota 58102
United States
Sanford Cancer Center Oncology Clinic ( Site 0038)
Sioux Falls, South Dakota 57104
United States
Fundacion Arturo Lopez Perez ( Site 0167)
Santiago, Region M. de Santiago 7500921
Chile
Centro de Oncología de Precisión ( Site 0160)
Santiago, Region M. de Santiago 7560908
Chile
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318)
Nanjing, Jiangsu 210000
China
The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306)
Nanchang, Jiangxi 330209
China
Zhongshan Hospital Fudan University ( Site 0319)
Shanghai, Shanghai Municipality 200032
China
West China Hospital, Sichuan University ( Site 0315)
Chengdu, Sichuan 610066
China
Kuopion Yliopistollinen Sairaala ( Site 0261)
Kuopio, Northern Savonia 70200
Finland
Vaasan Keskussairaala ( Site 0263)
Vaasa, Pohjanmaa 65130
Finland
Turku University Hospital ( Site 0262)
Turku, Southwest Finland 20520
Finland
HYKS Syöpätautien klinikka ( Site 0260)
Helsinki, Uusimaa 00290
Finland
Evangelismos General Hospital of Athens ( Site 0200)
Athens, Attica 106 76
Greece
Hong Kong Integrated Oncology Centre ( Site 0232)
Central, 0000
Hong Kong
Hong Kong United Oncology Centre ( Site 0231)
Kowloon,
Hong Kong
Queen Mary Hospital ( Site 0230)
Pokfulam,
Hong Kong
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175)
Milan, Lombardy 20133
Italy
Deventer Ziekenhuis ( Site 0272)
Deventer, Overijssel 7416 SE
Netherlands
Leids Universitair Medisch Centrum ( Site 0273)
Leiden, South Holland 2333 ZA
Netherlands
Severance Hospital Yonsei University Health System ( Site 0080)
Seoul, 03722
South Korea
Hospital Universitario Virgen de la Macarena ( Site 0093)
Seville, 41009
Spain
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0351)
Bangkok, Bangkok 10300
Thailand
Faculty of Medicine Siriraj Hospital ( Site 0350)
Bangkok, Bangkok 10700
Thailand
Erciyes University ( Site 0145)
Talas, Kayseri 38039
Turkey (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0141)
Adana, 1250
Turkey (Türkiye)
Koç Üniversitesi Hastanesi ( Site 0142)
Adana, 34010
Turkey (Türkiye)
Liv Hospital Ankara ( Site 0146)
Ankara, 06680
Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 0140)
Ankara, 6230
Turkey (Türkiye)
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)
Cherkasy, Cherkasy Oblast 18009
Ukraine
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)
Kryvyi Rih, Dnipropetrovsk Oblast 50000
Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018
Ukraine
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)
Kropyvnytskyi, Kirovohrad Oblast 25011
Ukraine
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)
Lviv, Lviv Oblast 79059
Ukraine
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)
Vinnitsya, Vinnytsia Oblast 21029
Ukraine
Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)
Uzhhorod, Zakarpattia Oblast 88000
Ukraine
VISION PARTNER Medical Centre ( Site 0135)
Kyiv, 03022
Ukraine
LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)
Kyiv, 03151
Ukraine