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)
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 3 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Sep 2, 2026 · Source: ClinicalTrials.gov
The study is currently accepting participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Drug: MK-1084; Biological: Pembrolizumab; Biological: Cetuximab; Biological: Sacituzumab tirumotecan (sac-TMT); Drug: Rescue medication
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
The main
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Clermont Oncology Center ( Site 0041)Clermont, Florida
- Sanford Health Roger Maris Cancer Center ( Site 0039)Fargo, North Dakota
- Sanford Cancer Center Oncology Clinic ( Site 0038)Sioux Falls, South Dakota
- Fundacion Arturo Lopez Perez ( Site 0167)Santiago, Region M. de Santiago
- Centro de Oncología de Precisión ( Site 0160)Santiago, Region M. de Santiago
- Bradfordhill ( Site 0168)Santiago, Region M. de Santiago
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318)Nanjing, Jiangsu
- The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306)Nanchang, Jiangxi
- Zhongshan Hospital Fudan University ( Site 0319)Shanghai, Shanghai Municipality
- West China Hospital, Sichuan University ( Site 0315)Chengdu, Sichuan
- Kuopion Yliopistollinen Sairaala ( Site 0261)Kuopio, Northern Savonia
- Vaasan Keskussairaala ( Site 0263)Vaasa, Pohjanmaa
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 2, 2026. Always confirm current availability with the study team.