A Randomized, Phase 2/3 Study to Evaluate the Optimal Dose, Safety, and Efficacy of Livmoniplimab in Combination with Budigalimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) – LIVIGNO-4 - M23-721

AbbVie Deutschland GmbH & Co. KG0 个研究点目标入组 160 人开始时间: 2024年3月13日最近更新: 2024年7月22日

适应症

试验速览

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•Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available., Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment., Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/ radiology assessment., Life expectancy of at least 3 months and adequate organ function., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2., Participant has completed palliative radiotherapy > 7 days from the first dose of study treatment., Diagnosis of histologically or cytologically confirmed metastatic nonsquamous non-small cell lung cancer (NSCLC) with no known epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) mutation, or other genomic aberration for which a locally approved targeted therapy is available., Must have at least 1 measurable lesion per response evaluation criteria in solid tumors (RECIST) v1.1 as determined by the local site Investigator/ radiology assessment., Life expectancy of at least 3 months and adequate organ function., Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

•Received prior systemic therapy for the treatment of metastatic NSCLC., Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia., Prior allogeneic stem cell or solid organ transplantation., History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins., History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody., Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia., Received prior systemic therapy for the treatment of metastatic NSCLC., Prior allogeneic stem cell or solid organ transplantation., History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins., History of positive test result(s) for hepatitis B (HBV) surface antigen or for hepatitis C (HCV) antibody.

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