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A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F)
190 patients around the world
Available in United States, Brazil, Chile
This is a substudy of the master protocol MK-3475-U01 (KEYMAKER-U01) - NCT04165798.
Merck Sharp & Dohme LLC
5Research sites
190Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.Provides archival tumor tissue sample of a tumor lesion not previously irradiated.Has provided tissue prior to treatment allocation/randomization from a newly obtained 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.
- The main exclusion criteria include but are not limited to the following.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 previous treatment with an agent targeting KRAS.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 history of (noninfectious) pneumonitis/ interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.Has an active infection requiring systemic therapy.Have not adequately recovered from major surgery or have ongoing surgical complications.
Sites
Hospital de Câncer de Barretos - Fundação PIO XII (Hospital de AMOR)
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
Recruiting
Hospital Paulistano
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07286149
