Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 主要终点
- PFS
研究概览
简要总结
Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.
This study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.
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
- •From October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:
- •Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30,
- •Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.
- •Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.
排除标准
- •From October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:
- •Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.
- •Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.
- •Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.
- •Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.
研究组 & 干预措施
treatment group
Using Anlotinib in Cross-line Treatment of NSCLC and SCLC
control group
Using Anlotinib in front-line treatment, but using an Anlotinib-free standard regimen in late-line treatment of NSCLC and SCLC
结局指标
主要结局
PFS
时间窗: From first dose date of Anlotinib until the date of progression based on imaging assessment or date of death from any cause, whichever came first, assessed up to 84 months
次要结局
未报告次要终点
研究者
Qiming Wang
chief physician
Henan Cancer Hospital