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)

Recruiting now · Phase 2

Conditions studied: Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT07252739

Run by

Merck Sharp & Dohme LLC

People needed

140

Starts

2025-12-19

Expected to finish

2033-01-14

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• 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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
• Has a history of stem cell/solid organ transplant
• Has not adequately recovered from major surgery or has ongoing surgical complications

Where it is running

• Clermont Oncology Center ( Site 0041) — Clermont, Florida, United States (enrolling)
• Sanford Health Roger Maris Cancer Center ( Site 0039) — Fargo, North Dakota, United States (enrolling)
• Sanford Cancer Center Oncology Clinic ( Site 0038) — Sioux Falls, South Dakota, United States (enrolling)
• Fundacion Arturo Lopez Perez ( Site 0167) — Santiago, Region M. de Santiago, Chile (enrolling)
• Centro de Oncología de Precisión ( Site 0160) — Santiago, Region M. de Santiago, Chile (enrolling)
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318) — Nanjing, Jiangsu, China (enrolling)
• The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306) — Nanchang, Jiangxi, China (enrolling)
• Zhongshan Hospital Fudan University ( Site 0319) — Shanghai, Shanghai Municipality, China (enrolling)
• West China Hospital, Sichuan University ( Site 0315) — Chengdu, Sichuan, China (enrolling)
• Kuopion Yliopistollinen Sairaala ( Site 0261) — Kuopio, Northern Savonia, Finland (enrolling)
• Vaasan Keskussairaala ( Site 0263) — Vaasa, Pohjanmaa, Finland (enrolling)
• Turku University Hospital ( Site 0262) — Turku, Southwest Finland, Finland (enrolling)
• HYKS Syöpätautien klinikka ( Site 0260) — Helsinki, Uusimaa, Finland (enrolling)
• Evangelismos General Hospital of Athens ( Site 0200) — Athens, Attica, Greece (enrolling)
• Hong Kong Integrated Oncology Centre ( Site 0232) — Central, Hong Kong (enrolling)
• Hong Kong United Oncology Centre ( Site 0231) — Kowloon, Hong Kong (enrolling)
• Queen Mary Hospital ( Site 0230) — Pokfulam, Hong Kong (enrolling)
• Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175) — Milan, Lombardy, Italy (enrolling)
• Deventer Ziekenhuis ( Site 0272) — Deventer, Overijssel, Netherlands (enrolling)
• Leids Universitair Medisch Centrum ( Site 0273) — Leiden, South Holland, Netherlands (enrolling)
• Severance Hospital Yonsei University Health System ( Site 0080) — Seoul, South Korea (enrolling)
• Hospital Universitario Virgen de la Macarena ( Site 0093) — Seville, Spain (enrolling)
• Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0351) — Bangkok, Bangkok, Thailand (enrolling)
• Faculty of Medicine Siriraj Hospital ( Site 0350) — Bangkok, Bangkok, Thailand (enrolling)
• Erciyes University ( Site 0145) — Talas, Kayseri, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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