A Retrospective Real-World Study on the Efficacy and Safety of Anlotinib Hydrochloride Combined With Immunotherapy as Maintenance Therapy Following First-Line Chemoimmunotherapy in Treatment-Naïve Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (ALTER-L059)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- PFS2
研究概览
简要总结
This retrospective real-world study aims to evaluate the efficacy and safety of anlotinib hydrochloride combined with immunotherapy as maintenance therapy following standard chemoimmunotherapy in extensive-stage small cell lung cancer (ES-SCLC).The study population consists of treatment-naïve ES-SCLC patients who did not progress after induction chemoimmunotherapy and subsequently received maintenance therapy with anlotinib plus immunotherapy. The primary objectives are progression-free survival (PFS)，overall survival (OS)
, and safety.
详细描述
This multicenter study seeks to retrospectively analyze medical records (January 2022-December 2024) of extensive-stage small cell lung cancer (ES-SCLC) patients treated with anlotinib hydrochloride (12/10/8 mg doses) alongside immune maintenance therapy after first-line chemoimmunotherapy in real-world clinical settings. Key data points will encompass demographics, baseline disease characteristics, treatment regimens, efficacy outcomes (e.g., objective response rate, progression-free survival), and adverse event profiles. Eligible patients must have received anlotinib for ≥6 weeks and possess evaluable radiographic assessments. The primary objectives are to assess the clinical effectiveness and safety of this combination strategy in ES-SCLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male or female patients aged 18 years or older;
- •Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC) (per the Veterans Administration Lung Study Group [VALG] staging criteria);
- •Patients who previously received chemotherapy for limited-stage SCLC must have undergone curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) and have a treatment-free interval of at least 6 months from the end of prior therapy (last chemotherapy cycle or radiotherapy) to the diagnosis of ES-SCLC;
- •At least one measurable target lesion (per RECIST version 1.1 criteria);
- •No disease progression after receiving 4-6 cycles of first-line chemoimmunotherapy induction therapy for ES-SCLC;
- •ECOG performance status: 0-2;
- •Life expectancy ≥3 months.
排除标准
- •Patients with limited-stage SCLC who previously received chemotherapy and underwent curative-intent therapy (e.g., chemotherapy, radiotherapy, or chemoradiotherapy) but experienced disease recurrence within 6 months after completion of prior therapy;
- •Patients with limited-stage SCLC who previously received immunotherapy agents (e.g., PD-1/PD-L1 inhibitors) or anti-angiogenic agents (e.g., Anlotinib, Apatinib, Bevacizumab);
- •Patients with extensive-stage small cell lung cancer (ES-SCLC) who developed disease progression during induction therapy with a standard chemoimmunotherapy regimen;
- •Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose;
- •Patients with coagulation dysfunction, defined as an International Normalized Ratio (INR) >1.5 or activated partial thromboplastin time (APTT) >1.5 × upper limit of normal (ULN), and/or those with a bleeding tendency;
- •Patients deemed by the inves.
结局指标
主要结局
PFS2
时间窗: up to 12 months
Progression-free survival from the initiation of anlotinib combined with immunotherapy maintenance treatment.
次要结局
- PFS(up to 12 months)
- 6-month PFS rate(up to 12 months)
- 12-month PFS rate(up to 12 months)
- OS(From diagnosis until death (up to 24 months))
- 6-month OS rate(up to 12 months)
- 12-month OS rate(up to 24 months)
- Incidence of Treatment-Emergent Adverse Events(up to 24 months)
研究者
Yong Fang
professor
Sir Run Run Shaw Hospital