2024-515051-38-00已完成3 期
A Two-Part Randomized, Phase 3 Study of Combinations of Cemiplimab (Anti- PD-1 Antibody) and Platinum-based Doublet Chemotherapy in First-line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer
Regeneron Pharmaceuticals Inc.16 个研究点 分布在 4 个国家目标入组 117 人开始时间: 2024年9月26日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 16
- 主要终点
- Overall survival
研究概览
简要总结
Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in <50% of tumor cells.
Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with stage IV disease if they have not received prior systemic treatment for recurrent or metastatic NSCLC
- •Availability of an archival (≤5 months) or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample from a metastatic or recurrent site, which has not previously been irradiated
- •Part 1 only: Expression of PD-L1 in <50% of tumor cells determined by a commercially available assay performed by the central laboratory
- •At least 1 radiographically measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria. Target lesions may be located in a previously irradiated field if there is documented (radiographic) disease progression in that site
- •Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
- •Anticipated life expectancy of at least 3 months
- •Note: Other protocol defined Inclusion criteria may apply
排除标准
- •Part 1 only: Patients who have never smoked, defined as smoking ≤100 cigarettes in a lifetime
- •Active or untreated brain metastases or spinal cord compression
- •Patients with tumors tested positive for Epidermal growth factor receptor (EGFR) gene mutations, Anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase(ROS1) fusions
- •Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrolment
- •History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years
- •Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (irTEAEs)
- •Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of randomization
- •Note: Other protocol defined Exclusion criteria may apply
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Progression-free survival
- Objective response rate
- Duration of Response (DOR)
- Best overall response (BOR)
- Incidence of Treatment-emergent adverse events (TEAEs)
- Part 1 only: Incidence of Dose-limiting toxicities (DLTs)
- Incidence of serious adverse events (SAEs)
- Incidence of deaths
- Incidence of laboratory abnormalities
- Overall survival rate
- Quality of life as measured by EORTC QLQ-C30
- Quality of life as measured by EORTC QLQ-LC13
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (16)
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