What is MK-1084 studying for Non-Small Cell Lung Cancer (NSCLC)?

MK-1084 is being studied as a targeted therapy for people with advanced or metastatic nonsquamous NSCLC that has a KRAS G12C gene mutation. Researchers want to understand the safety of MK-1084 and how well it might shrink or eliminate tumors during treatment. This study is sponsored by Merck Sharp & Dohme LLC to explore new treatment options for this lung cancer type.

Who may be eligible for this NSCLC clinical trial?

Adults 18 years or older with advanced or metastatic nonsquamous NSCLC that has a KRAS G12C mutation may be eligible. Participants must not have received prior systemic anticancer therapy for advanced disease and should not have active autoimmune disease needing systemic treatment. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this NSCLC clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study. Participants should consider potential travel costs when joining the trial.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID07252739

Phase 2 Study of Pembrolizumab Plus MK-1084 With or Without Cetuximab or Sacituzumab Tirumotecan for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutations

Led by Merck Sharp & Dohme LLC · Updated on 2026-07-30

140

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a study medicine called MK-1084 for treating advanced or metastatic nonsquamous Non-Small Cell Lung Cancer NSCLC with a specific KRAS G12C gene mutation. This phase 2 randomized trial aims to assess the safety of MK-1084 and how well it might shrink or eliminate tumors in people with this type of lung cancer. The study is sponsored by Merck Sharp & Dohme LLC and focuses on targeted therapy for this genetic mutation in cancer cells. Participants are randomly assigned to one of three treatment groups one group receives Pembrolizumab plus MK-1084 another group receives Pembrolizumab, MK-1084, and Cetuximab and the third group receives Pembrolizumab, MK-1084, and sacituzumab tirumotecan sac-TMT. Pembrolizumab is given every 6 weeks intravenously, Cetuximab and sac-TMT are administered every 2 weeks intravenously, and MK-1084 is given orally according to a dosing regimen. Rescue medications are provided to prevent infusion reactions and oral side effects. During the study, participants are monitored for dose limiting toxicities, adverse events, and discontinuations due to side effects over up to 84 months. Tumor response is measured using RECIST 1.1 criteria reviewed independently. Blood samples will be taken at designated times to study MK-1084 concentrations. Researchers will also track duration of response, progression-free survival, and overall survival. The study involves regular visits for treatment administration and safety assessments throughout the trial period.

CONDITIONS

Brief 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

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Has histologically or cytologically confirmed advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Has tumor tissue or circulating tumor DNA showing KRAS G12C mutations
Can provide an archival tumor tissue sample or new biopsy of a tumor lesion not previously irradiated
Has recovered to Grade 1 or baseline from prior adverse events and has Grade 2 or less neuropathy or endocrine-related adverse events adequately treated
Has well-controlled HIV on antiretroviral therapy if HIV-infected
Has undetectable hepatitis B viral load and received antiviral therapy for at least 4 weeks if hepatitis B surface antigen positive
Has undetectable hepatitis C viral load if infected

You will not qualify if you...

Has small cell lung cancer or mixed tumors with small cell elements
Has HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
Has severe dry eye syndrome, severe Meibomian gland disease, blepharitis, or severe corneal disease preventing or delaying corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease
Has uncontrolled or significant cardiovascular or cerebrovascular disease within 6 months before study
Has received prior systemic anticancer therapy for advanced or metastatic NSCLC
Has received prior immunotherapy discontinued due to severe immune-related adverse events
Has received previous treatment targeting KRAS
Has received systemic anticancer therapy within 4 weeks or 5 half-lives and not recovered to Grade 1 or baseline from related adverse events
Has received lung radiation over 30 Gray within 6 months before study
Has immunodeficiency or is receiving high-dose steroids or immunosuppressive therapy within 7 days prior to first dose
Has another progressing malignancy requiring active treatment in past 3 years
Has active central nervous system metastases or carcinomatous meningitis
Has active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
Has history or current pneumonitis or interstitial lung disease requiring steroids or suspected but not ruled out
Has history of stem cell or solid organ transplant
Has not recovered adequately from major surgery or has ongoing surgical complications

Research Team

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Phase 2 Study of Pembrolizumab Plus MK-1084 With or Without Cetuximab or Sacituzumab Tirumotecan for First-Line Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer with KRAS G12C Mutations

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria