Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy in China: A Multicenter, Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 46
- 主要终点
- Real-world disease-free survival (rwDFS)
研究概览
简要总结
This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult patients treated with Alectinib as adjuvant therapy in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed stage II-IIIA or selected IIIB (T3N2) NSCLC as per the American Joint Committee on Cancer and International Union Against Cancer (UICC/AJCC), 8th edition
- •ALK positive
- •Postoperative NSCLC patients who have undergone complete resection
- •Had taken Alectinib monotherapy without prior systemic therapy (including other ALK-TKIs or chemotherapy) as adjuvant† therapy for resected stage II-IIIB ALKpositive NSCLC and the time from the first dose to enrollment was no more than 28 days
排除标准
- •Patients participating in interventional study of adjuvant treatment
- •Pregnant, lactating, or breastfeeding women
研究组 & 干预措施
Cohort 1
Participants with resected stage II-IIIB ALK-positive NSCLC who have received Alectinib adjuvant therapy will be followed-up for approximately 2.5 years during routine visits at real-world clinical practice settings.
干预措施: Alectinib (Drug)
结局指标
主要结局
Real-world disease-free survival (rwDFS)
时间窗: From baseline to the date of the first documentation of cancer recurrence, as determined by the physician according to local clinical standard of care, or death due to any cause, whichever occurs first (up to approximately 2.5 years)
次要结局
- Duration of alectinib therapy(From start of treatment to the date of treatment discontinuation (up to approximately 2.5 years))
- Participant demographics by disease stage and city tier(Up to approximately 2.5 years)
- Participant clinical characteristics as determined by Eastern Cooperative Oncology Group performance status (ECOG PS) by disease stage and city tier(Up to approximately 2.5 years)
- Participant clinical characteristics as determined by surgery history by disease stage and city tier(Up to approximately 2.5 years)
- Emotional and physical functioning as determined by the 36-item short form survey (SF-36) v2 questionnaires(At enrollment, then every approximately 3 months thereafter (up to approximately 2.5 years))
- Incidence and severity of adverse events (AEs)(Baseline to withdrawal from study or 28 days after the last dose of alectinib, whichever occurs first)