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Study of MK-1084 with Other Treatments for Non-small Cell Lung Cancer

This study is looking into MK-1084, a targeted therapy, for advanced non-small cell lung cancer (NSCLC). Targeted therapies work by focusing on specific features of cancer cells to stop their growth. Researchers want to see how safe MK-1084 is and if it's well-tolerated when given with other treatments like Patritumab deruxtecan, Sacituzumab tirumotecan, or Cetuximab. They also want to find out if these treatments can make the cancer shrink or go away. You might be able to join if you have advanced NSCLC with a specific KRAS gene mutation. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 140 participants. It is a substudy of a larger master protocol.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 63 months and for discontinuing treatment due to adverse events for up to approximately 62 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.

NCT07286149

A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~140 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:MK-1084Patritumab deruxtecanSacituzumab tirumotecanCetuximabRescue Medications

At a glance

Recruiting sites
27 of 27 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Measured over Up to 42 days
+3 more outcomes measured

Conditions

Lung Neoplasm Malignant

Explore related trials

Lung Non-Small Cell CarcinomaGTPase KRas

Where it's being run

27 sites across 16 states
São Paulo3
Region M. de Santiago3
Hong Kong3
Israel3
Oregon2
Attica2
Spain2
Florida1

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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Has histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous 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 (KRAS) mutation of glycine to cysteine at codon 12 (G12C) mutations
Has documented disease progression after receiving 1-2 prior lines of programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) therapy and platinum-based chemotherapy
Has provided tumor tissue for biomarker analysis from an archival sample or a newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
Participants with human immunodeficiency virus (HIV) infection must have well-controlled HIV on antiretroviral therapy (ART) per protocol

Exclusion

Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has evidence of any leptomeningeal disease
Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization
Has one or more of the following ophthalmological conditions: a) Clinically significant corneal disease b) history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or current ILD, or suspected ILD
Has an active infection requiring systemic therapy
Has not adequately recovered from major surgery or has ongoing surgical complications

What this trial measures

  • Number of Participants Who Experience a Dose Limiting Toxicity (DLT)Up to 42 days

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 42 days) that results in a change to a given dose or a delay in initiating the next treatment.

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 63 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. The number of participants that experience AEs will be reported.

  • Number of Participants Who Discontinue Study Treatment Due to an AEUp to approximately 62 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. The number of participants that discontinue study intervention due to an AE will be reported.

  • Objective Response Rate (ORR)Up to approximately 63 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 Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.