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 · NCT07252739 on ClinicalTrials.gov ↗
Conditions studied
What it tests
- MK-1084drug
- Pembrolizumabbiological
- Cetuximabbiological
- Carboplatindrug
- Pemetrexeddrug
Where it's running28 sites
- Recruiting now
Clermont Oncology Center ( Site 0041)
Clermont, Florida 34711
- Study Coordinator(contact)386-538-3169
- Recruiting now
Sanford Health Roger Maris Cancer Center ( Site 0039)
Fargo, North Dakota 58102
- Study Coordinator(contact)701-234-2000
- Recruiting now
Sanford Cancer Center Oncology Clinic ( Site 0038)
Sioux Falls, South Dakota 57104
- Study Coordinator(contact)605-328-8000
25 international sites
- Recruiting now
Centro de Oncología de Precisión ( Site 0160)
Santiago, Region M. de Santiago, Chile 7560908
- Study Coordinator(contact)+56978611788
- Recruiting now
West China Hospital, Sichuan University ( Site 0315)
Chengdu, Sichuan, China 610066
- Study Coordinator(contact)+8618980602252
- Recruiting now
Kuopion Yliopistollinen Sairaala ( Site 0261)
Kuopio, Northern Savonia, Finland 70200
- Study Coordinator(contact)+35817173311
- Recruiting now
Vaasan Keskussairaala ( Site 0263)
Vaasa, Pohjanmaa, Finland 65130
- Study Coordinator(contact)+358405533545
- Recruiting now
Turku University Hospital ( Site 0262)
Turku, Southwest Finland, Finland 20520
- Study Coordinator(contact)+35823138709
- Recruiting now
HYKS Syöpätautien klinikka ( Site 0260)
Helsinki, Uusimaa, Finland 00290
- Study Coordinator(contact)+358406682951
- Recruiting now
Hong Kong United Oncology Centre ( Site 0231)
Kowloon, Hong Kong
- Study Coordinator(contact)+852 2386 8002
- Recruiting now
Queen Mary Hospital ( Site 0230)
Pokfulam, Hong Kong
- Study Coordinator(contact)+85222551727
- Recruiting now
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175)
Milan, Lombardy, Italy 20133
- Study Coordinator(contact)00390223903829
- Recruiting now
Deventer Ziekenhuis ( Site 0272)
Deventer, Overijssel, Netherlands 7416 SE
- Study Coordinator(contact)+31570536437
- Recruiting now
Leids Universitair Medisch Centrum ( Site 0273)
Leiden, South Holland, Netherlands 2333 ZA
- Study Coordinator(contact)+31715566376
- Recruiting now
Severance Hospital Yonsei University Health System ( Site 0080)
Seoul, South Korea 03722
- Study Coordinator(contact)+82222280880
- Recruiting now
Hospital Universitario Virgen de la Macarena ( Site 0093)
Seville, Spain 41009
- Study Coordinator(contact)+34 671560092
- Recruiting now
Koç Üniversitesi Hastanesi ( Site 0142)
Adana, Turkey (Türkiye) 34010
- Study Coordinator(contact)08502508250-21251
- Recruiting now
Liv Hospital Ankara ( Site 0146)
Ankara, Turkey (Türkiye) 06680
- Study Coordinator(contact)905469299990
- Recruiting now
Hacettepe Universite Hastaneleri ( Site 0140)
Ankara, Turkey (Türkiye) 6230
- Study Coordinator(contact)+90 312 305 50 00
- Recruiting now
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)
Cherkasy, Cherkasy Oblast, Ukraine 18009
- Study Coordinator(contact)+380472370123
- Recruiting now
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine 50000
- Study Coordinator(contact)+380677490687
- Recruiting now
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine 76018
- Study Coordinator(contact)380978411455
- Recruiting now
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine 25011
- Study Coordinator(contact)+380958718674
- Recruiting now
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)
Lviv, Lviv Oblast, Ukraine 79059
- Study Coordinator(contact)+380677724757
- Recruiting now
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)
Vinnitsya, Vinnytsia Oblast, Ukraine 21029
- Study Coordinator(contact)380953105783
- Recruiting now
Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)
Uzhhorod, Zakarpattia Oblast, Ukraine 88000
- Study Coordinator(contact)+380506847086
- Recruiting now
VISION PARTNER Medical Centre ( Site 0135)
Kyiv, Ukraine 03022
- Study Coordinator(contact)380989648486
- Recruiting now
LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)
Kyiv, Ukraine 03151
- Study Coordinator(contact)+380671502987
See the official eligibility language
Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC) * Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations * Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated * Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement * Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected * Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive * Has undetectable hepatitis C (HCV) viral load if HCV-infected Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements * Has HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease * Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention * Has received prior systemic anticancer therapy for advanced or metastatic NSCLC * Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis * Has received previous treatment with an agent targeting KRAS * Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before allocation/randomization * Has received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has a known additional malignancy that is progressing or has required active treatment within the past 3 years * Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Updated 2026-06-12 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.