Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-12
130
Participants Needed
22
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC)
- Presence of KRAS G12C mutation in tumor tissue or circulating tumor DNA (ctDNA)
- Able to provide archival tumor tissue or new biopsy sample from a tumor lesion not previously irradiated
- Recovered to Grade 1 or baseline from prior anticancer therapy adverse events and no more than Grade 2 neuropathy or endocrine-related adverse events adequately treated
- Well controlled HIV infection on antiretroviral therapy (if HIV positive)
- Undetectable hepatitis B viral load and on antiviral therapy for at least 4 weeks if hepatitis B surface antigen positive
- Undetectable hepatitis C viral load if infected with hepatitis C
You will not qualify if you...
- Diagnosis of small cell lung cancer or tumor with small cell elements
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active inflammatory bowel disease requiring immunosuppressive treatment or past clear history of inflammatory bowel disease
- Uncontrolled or significant cardiovascular or cerebrovascular disease including severe heart failure, unstable angina, recent heart attack, symptomatic arrhythmia, prolonged QTc interval, or other serious conditions within 6 months prior to study
- Prior systemic anticancer therapy for advanced or metastatic NSCLC
- Prior immunotherapy discontinued due to Grade 3 or higher immune-related adverse events (except endocrine disorders managed with replacement therapy) or due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Previous treatment targeting KRAS
- Recent systemic anticancer therapy within 4 weeks or 5 half-lives without recovery to baseline from related adverse events
- Radiation therapy to lung above 30 Gray within 6 months before study
- Immunodeficiency diagnosis or use of chronic systemic steroids above 10 mg prednisone equivalent daily or other immunosuppressive therapy within 7 days before first dose
- Active malignancy requiring treatment or progressing within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- History or current pneumonitis/interstitial lung disease requiring steroids
- History of stem cell or solid organ transplant
- Not fully recovered from major surgery or ongoing surgical complications
AI-Screening
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Trial Site Locations
Total: 22 locations
1
Clermont Oncology Center ( Site 0041)
Clermont, Florida, United States, 34711
Actively Recruiting
2
Sanford Health Roger Maris Cancer Center ( Site 0039)
Fargo, North Dakota, United States, 58102
Actively Recruiting
3
Sanford Cancer Center Oncology Clinic ( Site 0038)
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
4
West China Hospital, Sichuan University ( Site 0315)
Chengdu, Sichuan, China, 610066
Actively Recruiting
5
Kuopion Yliopistollinen Sairaala ( Site 0261)
Kuopio, Northern Savonia, Finland, 70200
Actively Recruiting
6
Turku University Hospital ( Site 0262)
Turku, Southwest Finland, Finland, 20520
Actively Recruiting
7
HYKS Syöpätautien klinikka ( Site 0260)
Helsinki, Uusimaa, Finland, 00290
Actively Recruiting
8
Hong Kong United Oncology Centre ( Site 0231)
Kowloon, Hong Kong
Actively Recruiting
9
Deventer Ziekenhuis ( Site 0272)
Deventer, Overijssel, Netherlands, 7416 SE
Actively Recruiting
10
Leids Universitair Medisch Centrum ( Site 0273)
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
11
Severance Hospital Yonsei University Health System ( Site 0080)
Seoul, South Korea, 03722
Actively Recruiting
12
Hospital Universitario Virgen de la Macarena ( Site 0093)
Seville, Spain, 41009
Actively Recruiting
13
Hacettepe Universite Hastaneleri ( Site 0140)
Ankara, Turkey (Türkiye), 6230
Actively Recruiting
14
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)
Cherkasy, Cherkasy Oblast, Ukraine, 18009
Actively Recruiting
15
Medical Center "Mriya Med-Service"-Clinical Research Department ( Site 0465)
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50000
Actively Recruiting
16
Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Surgery department #2 ( Site 0132)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018
Actively Recruiting
17
Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25011
Actively Recruiting
18
Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)
Lviv, Lviv Oblast, Ukraine, 79059
Actively Recruiting
19
Communal Noncommercial Enterprise "Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)
Vinnitsya, Vinnytsia Oblast, Ukraine, 21029
Actively Recruiting
20
Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)
Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
Actively Recruiting
21
VISION PARTNER Medical Centre ( Site 0135)
Kyiv, Ukraine, 03022
Actively Recruiting
22
LIMITED LIABILITY COMPANY "MEDICAL CENTER "DOBROBUT-CLINIC" ( Site 0138)
Kyiv, Ukraine, 03151
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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