2023-506861-76-00招募中3 期
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients with Completely Resected Stage Ib (Tumors ≥ 4 Cm) to Stage IIIa Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 30
- 主要终点
- 1. Disease-free survival per investigator’s assessment
研究概览
简要总结
To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage Ib (tumors ≥4 cm) to Stage IIIa, ALK-positive NSCLC based on investigator assessed disease-free survival
研究设计
- 分配方式
- Randomized
- 主要目的
- Efficacy and safety of Alectinib versus Platinum-Based Chemo in patients with NSCL
- 盲法
- None
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
- •Complete resection of histologically-confirmed Stage Ib (tumor ≥ 4 cm) to Stage IIIa (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per UICC/AJCC, 7th edition, with negative margins, at 4-12 weeks before enrollment
- •Documented ALK-positive disease according to an FDA-approved and CE-marked test
- •Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines
- •Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1
- •Adequate hematologic and renal function
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
排除标准
- •Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy
- •Prior adjuvant radiotherapy for NSCLC Prior exposure to systemic anti-cancer therapy and ALK inhibitors
- •Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study
- •Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption.
- •Significant liver disease or impaired liver transaminase enzymes levels, symptomatic bradycardia, any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection, HIV positivity
结局指标
主要结局
1. Disease-free survival per investigator’s assessment
1. Disease-free survival per investigator’s assessment
次要结局
- 1. Overall survival
- 2. Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 45.0
- 3. Incidence of abnormal laboratory findings
- 4. Changes in vital signs and electrocardiograms
- 5. Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (30)
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