NCT04325776Unknown2 期
A Randomized, Double-blind and Imitation, Parallel-control, Multicenter Phase II Study of AL2846 Versus Zoledronic Acid in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC) With Bone Metastasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- The time when the first bone-related event (SRE) occurred
研究概览
简要总结
AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met, suggesting that its anti-tumor effect mainly inhibits the activation of key downstream oncogenic pathways by inhibiting expression of c-met, tumor angiogenesis and tumor cell migration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1.Understood and signed an informed consent form. 2.18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •3.Histologically confirmed advanced non-small cell lung cancer with at least one bone metastatic lesion with bone destruction.
- •4.Has received at least two systematic treatment regimens that failed or were unable to tolerate treatment.
- •5.EGFR, ALK gene mutations are negative. 6.Adequate laboratory indicators. 7.No pregnant or breastfeeding women, and a negative pregnancy test.
排除标准
- •1.Small cell lung cancer.
- •Diagnosed and/or treated additional malignancy within 5 years with the exception of cured cervical carcinoma in situ and non-melanoma skin cancer.
- •Has received radiotherapy, chemotherapy and surgery before and less than 4 weeks from the first administration and less than 5 half-lives of oral targeted drugs after the completion of treatment.
- •Has received systemic radionuclide therapy or semi-extracorporeal radiation for bone metastases.
- •Has known to be allergic to the study drug or any of its excipients.
- •Has symptomatic brain metastases, spinal cord compression, and cancerous meningitis within 8 weeks,or brain or pia mater disease confirmed by CT or MRI examination before the first dose.
- •Has adverse events caused by previous therapy that did not recover to ≤ grade 1, with the exception of alopecia or ≥ grade 2 neurotoxicity caused by Oxaliplatin.
- •Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary with blood vessels is unclear.
- •Has spinal cord compression or mandibular osteonecrosis. 10.Has multiple factors that affect oral medications. 11.Has gastroduodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
- •12.Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- •Has severe acute comorbidities before the first dose.
- •Has participated in other clinical trials within 4 weeks before the first dose.
- •15.According to the investigators' judgment.
研究组 & 干预措施
AL2846+An analog of zoledronic acid injection
Experimental
AL2846 capsules 150 mg given orally, once daily in 28-day cycle, an analog of zoledronic acid injection (5ml:0mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
干预措施: AL2846 (Drug)
An analog of AL2846+ zoledronic acid injection
Active Comparator
An analog of AL2846 capsules 0 mg given orally, once daily in 28-day cycle, zoledronic acid injection (5ml:4mg) administered intravenously (IV) on Day 1 of each 28-day cycle.
干预措施: Zoledronic Acid Injection (Drug)
结局指标
主要结局
The time when the first bone-related event (SRE) occurred
时间窗: up to 96 weeks
The time from the randomization to the first occurrence of any meeting of bone-related event criteria.
次要结局
- Effectiveness of improving average daily pain intensity on week 8 and 16 (Refer to Brief pain inventory (BPI) and the Verbal rating scale (VRS)(on 8 and 16 week)
- Progression-free survival (PFS)(up to 96 weeks)
- Biomarkers(up to 96 weeks)
- Overall response rate (ORR)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Overall survival (OS)(up to 96 weeks)
- Disease control rate（DCR）(up to 96 weeks)
研究者
研究点 (8)
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