招募中 NCT07286149

MK-1084与其他治疗非小细胞肺癌的临床研究( MK-3475-01F )

非小细胞肺癌肉瘤Phase IIII 期IV 期KRASPD-L1

研究人员希望了解研究药物MK-1084是否可以治疗晚期或转移性非鳞状NSCLC。 MK-1084是一种靶向疗法,可用于控制特定类型的癌细胞如何生长和扩散。 本研究的目标是学习: *关于MK-1084的安全性,以及人们与其他治疗药物一起服用时是否耐受 *有多少人对治疗产生癌症反应(变小或消失)

适应症:Lung Neoplasm Malignant

入组条件

纳入标准

  • 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

排除标准

  • 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

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。