2023-505773-32-00招募中3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 57
- 试验地点
- 21
- 主要终点
- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
研究概览
简要总结
- Stage 1 (Phase 2): To assess the safety and activity of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy and to select recommended Phase 3 dose (RP3D) for livmoniplimab.
- Stage 2 (Phase 3): To evaluate the activity of the RP3D of livmoniplimab and budigalimab in combination with platinum doublet chemotherapy versus pembrolizumab in combination with platinum doublet chemotherapy as measured by overall survival (OS).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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.
结局指标
主要结局
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
Stage 2: Overall Survival (OS)
Stage 2: Overall Survival (OS)
次要结局
- Stage 1: Progression Free Survival (PFS)
- Stage 1: Duration of Response (DOR)
- Stage 1: Overall Survival (OS)
- Stage 2: Progression Free Survival (PFS)
- Stage 2: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR)
- Stage 2: Change from Baseline in Physical Functioning (PF) as measured by the PF domain of European Organization for Research Treatment of Cancer Quality of Life Questionnaire 17 (EORTC QLQ-F17)
- Stage 2: Change from Baseline in Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ)
- Stage 2: Change from Baseline in Quality of Life as Measured by the Global Health Status/Quality of Life Domain of the EORTC QLQ-F17
- Stage 2: Progression Free Survival per Investigator
- Stage 1: Best Overall Response (BOR) of Complete Response (CR)/Partial Response (PR) per Investigator
- Stage 2: Duration of Response (DOR)
- Stage 2: DOR per investigator
研究者
Bernhard Dodell
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (21)
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