NCT05106335终止3 期
A Randomized, Open-Label, Controlled, Multi-Center Phase III Clinical Study of Camrelizumab Combined With Famitinib Malate Versus Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer Who Progressed on Prior Immune Checkpoint Inhibitor Treatment and Platinum-Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate versus docetaxel as subsequent therapy in Advanced NSCLC.
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
- 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
- •Histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer.
- •Failed previous platinum-based chemotherapy and anti-PD-(L)1 monoclonal antibody treatment.
- •Have measurable disease based on RECIST v1.
- •ECOG PS score: 0-
- •Expected survival ≥ 3 months.
- •Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and until 6 months after the last study dose.
- •Subjects must participate voluntarily, sign the ICF, have good compliance, and cooperate with follow-up visits.
排除标准
- •Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
- •Have known history of prior malignancy in the past 3 years.
- •Have active pulmonary tuberculosis.
- •Have clinical symptoms of the heart or heart diseases that are not well controlled.
- •Have hypertension which cannot be well controlled by antihypertensives
- •Urinalysis has indicated that the urine protein is ≥ ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.
- •Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
- •Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤
- •Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
- •Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.
- •Previous treatment with camrelizumab, docetaxel, and small-molecule VEGFR inhibitors including famitinib.
- •Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator.
研究组 & 干预措施
Treatment Arm A
Experimental
camrelizumab + famitinib
干预措施: camrelizumab + famitinib (Drug)
Treatment Arm C
Experimental
famitinib
干预措施: famitinib (Drug)
Treatment Arm B
Active Comparator
docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
OS
时间窗: up to 4 years
OS is the time interval from the date of randomization to death due to any reason or lost of follow-up.
次要结局
- PFS(up to 4 years)
- DCR(up to 4 years)
- ORR(up to 4 years)
- DoR(up to 4 years)
- TTF(up to 4 years)
研究者
研究点 (1)
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