Tests MK-1084 with other treatments for lung cancer with KRAS G12C mutation

Trial details

Who runs it

Merck Sharp & Dohme LLC

Trial code

NCT07286149EU 2024-512248-47-00

Record updated

1 October 2026

Original description

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:Read full original descriptionShow less

KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations

Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:

* About the safety of MK-1084 and if people tolerate it when taken with other treatments * How many people have the cancer respond (get smaller or go away) to the treatments

Inclusion: The main inclusion criteria include but are not limited to the following:; 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 active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease; Has uncontrolled or significant cardiovascular disorder or cerebrovascular disease prior to allocation/randomization; 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 not adequately recovered from major surgery or has ongoing surgical complications; 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 evidence of any leptomeningeal disease; 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 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; The main exclusion criteria include but are not limited to the following:; Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

ClinicalTrials.gov NCT07286149 · EU CTIS 2024-512248-47-00