NCT04322617招募中2 期
Anlotinib With or Without Immune Checkpoint Inhibitors in Standard Chemo-immunotherapy Failed Advanced Non-small Cell Lung Cancer
Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2020年3月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Progression free survival time (PFS)
研究概览
简要总结
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC.
详细描述
This study aims to explore the efficacy of Anlotinib with or without Immune Checkpoint Inhibitor in Standard Chemo-immunotherapy Failed Advanced NSCLC. The primary endpoint was PFS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 or cytology confirmed lung cancer
- •Failed from first line Chemo-immunotherapy.
- •Predicted survival ≥ 12 weeks.
- •Adequate bone marrow hematopoiesis and organ function
- •Presence of measurable lesions according to RECIST 1.
- •Subjects with stable brain metastases may be included in the study.
排除标准
- •Subjects who have received any of the following treatments must be excluded:
- •Treatment with molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
- •Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
- •Ongoing (or inability to discontinue) possibly potent CYP1A2, CYP3A inhibitor (1 week), or inducer (2 weeks) drug therapy or herbal supplements within 1-2 weeks prior to the first dose.
- •Presence of spinal cord compression or meningeal metastasis.
- •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
Cohort A: Anlotinib with the same Immune Checkpoint Inhibitors.
Experimental
Anlotinib plus Immune Checkpoint Inhibitors which has been used in first line treatment.
干预措施: Anlotinib plus the same Immune Checkpoint Inhibitors. (Drug)
Cohort B: Anlotinib with the new Immune Checkpoint Inhibitors.
Experimental
Anlotinib plus Immune Checkpoint Inhibitors which has not been used in first line treatment.
干预措施: Anlotinib plus the new Immune Checkpoint Inhibitors. (Drug)
Cohort C: Anlotinib Monotherapy.
Experimental
Anlotinib Monotherapy.
干预措施: Anlotinib (Drug)
结局指标
主要结局
Progression free survival time (PFS)
时间窗: Time from first subject dose to study completion, or up to 36 month.
Progression free survival time define as first dose to first documented disease progression assessed by investigator or death due to any cause.
次要结局
- Objective Response Rate (ORR)(Time from first subject dose to study completion, or up to 36 month.)
- Overall survival (OS)(Time from first subject dose to study completion, or up to 36 month.)
研究者
Yongchang Zhang
Professor, Director of Clinical Trial Center
Hunan Province Tumor Hospital
研究点 (1)
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