2023-506859-13-00已完成3 期
Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib In Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 10
- 主要终点
- 1. PFS, as assessed by investigator
研究概览
简要总结
To evaluate and compare the efficacy of alectinib compared with crizotinib in patients with treatment-naive anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC), as measured by investigator-assessed progression-free survival (PFS)
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomized, Multicenter, Phase Iii, Open-label Study Of Alectinib Versus Crizotinib In Treatment-nai
- 盲法
- None
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
- 是
入选标准
- •Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is ALK-positive as assessed by the Ventana immunohistochemistry (IHC) test. Sufficient tumor tissue to perform ALK IHC and ALK fluorescent in situ hybridization (FISH) is required. Both tests will be performed at designated central laboratories.
- •Measurable disease (by Response Evaluation Criteria In Solid Tumors [RECIST] v1.1) prior to the administration of study treatment
- •Patients had no prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2
- •Adequate hematologic, renal and liver function.
- •Prior brain or leptomeningeal metastases allowed if asymptomatic (e.g., diagnosed incidentally at study baseline). Asymptomatic CNS lesions might be treated at the discretion of the investigator as per local clinical practice. If patients have neurological symptoms or signs due to CNS metastasis, patients need to complete whole brain radiation or gamma knife irradiation treatment. In all cases, radiation treatment must be completed at least 14 days before enrollment and patients must be clinically stable.
排除标准
- •Patients with a previous malignancy within the past 3 years are excluded (other than curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, or any cured cancer that is considered to have no impact in PFS and OS for the current NSCLC).
- •Any gastrointestinal (GI) disorder that may affect absorption of oral medications, such as mal absorption syndrome or status post-major bowel resection
- •National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) Grade 3 or higher toxicities due to any prior therapy such as radiotherapy (excluding alopecia), which have not shown improvement and are strictly considered to interfere with current study medication
- •Liver disease - ALT or AST > 3 x upper limit of normal OR - Impaired excretory function OR - Acute viral or active autoimmune alcoholic, or other types of acute hepatitis Patients with baseline QTc > 470 ms or symptomatic bradycardia
- •Administration of strong/potent cytochrome P4503A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib or crizotinib.
- •Administration of agents with potential QT interval prolonging effects within 14 days prior to the first administration of study drug for all patients and while on treatment through the end of the study for crizotinib-treated patients only
结局指标
主要结局
1. PFS, as assessed by investigator
1. PFS, as assessed by investigator
次要结局
- 4. DOR
- 2. Time to CNS Progression by IRC
- 3. ORR as determined by the investigators using RECIST v1.1.
- 1. PFS by IRC
- 5. Time to deterioration (TTD) in patient-reported lung cancer symptoms
- 6. Health-related quality of life (HRQoL)
- 7. Safety and tolerability
- 8. Pharmacokinetics of alectinib and metabolite(s)
- 9. Overall survival (OS)
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (10)
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