Efficacy and Safety of Third-generation EGFR-TKI Combined With Anlotinib as Maintenance Therapy Following 4-6 Cycles of Chemotherapy and Immunotherapy in NSCLC With Small Cell Transformation After EGFR-TKI Resistance: a Single-arm Prospective Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.
详细描述
This prospective interventional clinical study aims to evaluate the efficacy and safety of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6 cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung cancer patients who developed small cell transformation after EGFR-TKI resistance were enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is expected to commence recruitment in mainland China in about November 2024. It is expected that the trial will end in December 2026.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- •Age ≥ 18 years.
- •Histopathology is confirmed non-small cell lung cancer .
- •4.Patients with advanced non-small cell lung cancer (NSCLC) who experienced small cell transformation after EGFR-TKI resistance.
- •Predicted survival ≥ 12 weeks. .
- •Adequate bone marrow hematopoiesis and organ function.
排除标准
- •History of other malignant tumors within 2 years.
- •Adverse events (except alopecia of any degree) of CTCAE > grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
- •History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- •The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
- •Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
- •Heart-related diseases or abnormalities
- •Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
- •Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
- •Live vaccine was given 2 weeks before the first medication.
- •Women who are breastfeeding or pregnant.
- •Hypersensitivity to the test drug and the ingredients.
- •Other conditions assessed by the investigator to be unsuitable for participation in the study.
研究组 & 干预措施
The experimental cohort
third-generation EGFR-TKI combined with anlotinib
干预措施: third-generation EGFR-TKI combined with anlotinib (Drug)
结局指标
主要结局
progression-free survival (PFS)
时间窗: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up
次要结局
- Objective Response Rate (ORR)(Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month)
- Adverse events (AEs) according to CTCAE 5.0(Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month)
研究者
Yongchang Zhang
Director, Head of Medical Oncology, Principal Investigator, Clinical Professor
Hunan Province Tumor Hospital