Back to search results

KEYMAKER-U01 Substudy 01J: Pembrolizumab Plus MK-1084 for NSCLC with KRAS G12C Mutations

This study is testing a combination of medicines, MK-1084 and pembrolizumab, for people with advanced or metastatic non-small cell lung cancer (NSCLC). You may be able to join if your cancer has a specific change called a KRAS G12C mutation. Researchers want to understand how safe these medicines are and if they can make the cancer shrink or go away. The study is also looking at other treatments like cetuximab, carboplatin, and pemetrexed. The study plans to enroll about 130 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 130 participants. It is testing multiple interventions including MK-1084, pembrolizumab, cetuximab, carboplatin, and pemetrexed.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and discontinuations due to adverse events for up to approximately 84 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07252739

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
PHASE2Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~140 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:MK-1084PembrolizumabCetuximabSacituzumab tirumotecan (sac-TMT)Rescue medication

At a glance

Recruiting sites
38 of 38 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with a Dose Limiting Toxicity (DLT)
Measured over Up to approximately 21 days
+3 more outcomes measured

Conditions

Malignant Neoplasm

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRasProgrammed Cell Death Protein 1

Where it's being run

38 sites across 30 states
Turkey (Türkiye)4
Hong Kong3
Region M. de Santiago2
Bangkok2
Ukraine2
Florida1
North Dakota1
South Dakota1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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 AEUp 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.