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)
Condition(s) studied
Investigational drug(s) / intervention(s)
MK-1084: Oral Administration
Pembrolizumab: Intravenous administration
Cetuximab: Intravenous administration
Sacituzumab tirumotecan (sac-TMT): Injection powder for intravenous infusion
Rescue medication: Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[Hl\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion, and granulocyte colony-stimulating factor (G-CSF). A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Study 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
Primary outcome measure(s)
- Percentage of Participants with a Dose Limiting Toxicity (DLT) — Up to approximately 21 days
A DLT is defined as the occurrence of protocol-specified toxicities if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration, excluding toxicities clearly not related to the drug. - Percentage of Participants who Experience at Least One Adverse Event (AE) — Up to approximately 84 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Percentage of Participants who Discontinue Study Intervention Due to an AE — Up to approximately 84 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. - Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR) — Up to approximately 84 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Trial sites (39)
| Facility | City | Region | Status |
|---|---|---|---|
| Clermont Oncology Center ( Site 0041) | Clermont | Florida | Recruiting |
| Sanford Health Roger Maris Cancer Center ( Site 0039) | Fargo | North Dakota | Recruiting |
| Sanford Cancer Center Oncology Clinic ( Site 0038) | Sioux Falls | South Dakota | Recruiting |
| Fundacion Arturo Lopez Perez ( Site 0167) | Santiago | Region M. de Santiago | Recruiting |
| Centro de Oncología de Precisión ( Site 0160) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 0168) | Santiago | Region M. de Santiago | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318) | Nanjing | Jiangsu | Recruiting |
| The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306) | Nanchang | Jiangxi | Recruiting |
| Zhongshan Hospital Fudan University ( Site 0319) | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital, Sichuan University ( Site 0315) | Chengdu | Sichuan | Recruiting |
| Kuopion Yliopistollinen Sairaala ( Site 0261) | Kuopio | Northern Savonia | Recruiting |
| Vaasan Keskussairaala ( Site 0263) | Vaasa | Pohjanmaa | Recruiting |
| Turku University Hospital ( Site 0262) | Turku | Southwest Finland | Recruiting |
| HYKS Syöpätautien klinikka ( Site 0260) | Helsinki | Uusimaa | Recruiting |
| Evangelismos General Hospital of Athens ( Site 0200) | Athens | Attica | Recruiting |
| Hong Kong Integrated Oncology Centre ( Site 0232) | Central | Hong Kong | Recruiting |
| Queen Mary Hospital ( Site 0230) | Hong Kong | Hong Kong | Recruiting |
| Hong Kong United Oncology Centre ( Site 0231) | Kowloon | Hong Kong | Recruiting |
| Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175) | Milan | Lombardy | Recruiting |
| Deventer Ziekenhuis ( Site 0272) | Deventer | Overijssel | Recruiting |
| Leids Universitair Medisch Centrum ( Site 0273) | Leiden | South Holland | Recruiting |
| Severance Hospital Yonsei University Health System ( Site 0080) | Seoul | South Korea | Recruiting |
| Hospital Universitario Virgen de la Macarena ( Site 0093) | Seville | Spain | Recruiting |
| Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0351) | Bangkok | Bangkok | Recruiting |
| Faculty of Medicine Siriraj Hospital ( Site 0350) | Bangkok | Bangkok | Recruiting |
| Erciyes University ( Site 0145) | Talas | Kayseri | Recruiting |
| Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0141) | Adana | Turkey (Türkiye) | Recruiting |
| Koç Üniversitesi Hastanesi ( Site 0142) | Adana | Turkey (Türkiye) | Recruiting |
| Liv Hospital Ankara ( Site 0146) | Ankara | Turkey (Türkiye) | Recruiting |
| Hacettepe Universite Hastaneleri ( Site 0140) | Ankara | Turkey (Türkiye) | Recruiting |
| COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139) | Cherkasy | Cherkasy Oblast | Recruiting |
| Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465) | Kryvyi Rih | Dnipropetrovsk Oblast | Recruiting |
| Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132) | Ivano-Frankivsk | Ivano-Frankivsk Oblast | Recruiting |
| Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467) | Kropyvnytskyi | Kirovohrad Oblast | Recruiting |
| Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133) | Lviv | Lviv Oblast | Recruiting |
| Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131) | Vinnitsya | Vinnytsia Oblast | Recruiting |
| Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137) | Uzhhorod | Zakarpattia Oblast | Recruiting |
| VISION PARTNER Medical Centre ( Site 0135) | Kyiv | Ukraine | Active Not Recruiting |
| LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138) | Kyiv | Ukraine | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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