A Randomized, Double-Blind, Multicenter, Phase Ⅲ Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy Versus Placebo Combined With Chemotherapy in Subjects With Squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 3 期
- 入组人数
- 386
- 试验地点
- 2
- 主要终点
- Progression Free Survival (PFS) evaluated by IRC
研究概览
简要总结
Anlotinib hydrochloride is a multi-targeted receptor tyrosine kinase inhibitor that targets angiogenesis-related kinases such as VEGFR1/2/3, FGFR1/2/3, and other tumor-associated kinases involved in cell proliferation such as PDGFRα/β, c-Kit, and Ret have significant inhibitory activities.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Squamous non-small cell lung cancer.
- •A measurable lesion.
- •The disease progression occurs >12 months after the end of the last treatment. 4.18-75 years old ; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
- •5.Adequate laboratory indicators. 6.No pregnant or breastfeeding women, and a negative pregnancy test. 7.Understood and signed an informed consent form.
排除标准
- •The tumor invades the large blood vessels.
- •Central type squamous non-small cell lung cancer.
- •EGFR/ALK gene mutation is positive.
- •Has used EGFR inhibitors and ALK inhibitors.
- •Has other malignant tumors within 5 years.
- •Has a variety of factors affecting oral medications.
- •Symptomatic brain metastasis.
- •Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage.
- •Spinal cord compression.
- •Has received radiotherapy, chemotherapy, surgery less than 4 weeks before randomization.
- •Severe allergies to therapeutic medications.
- •Adverse events caused by previous treatment did not recover to grade
- •Has received major surgical treatment within 4 weeks before randomization.
- •Arteriovenous thrombosis occurred within 6 months.
- •Has drug abuse history that unable to abstain from or mental disorders.
- •Has severe or uncontrolled disease.
- •Participated in other clinical trials within 4 weeks.
- •According to the investigators' judgement.
研究组 & 干预措施
Experimental group
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Anlotinib (Drug)
Experimental group
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Paclitaxel (Drug)
Experimental group
Anlotinib hydrochloride capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Carboplatin (Drug)
Placebo group
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Placebos (Drug)
Placebo group
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Paclitaxel (Drug)
Placebo group
Anlotinib hydrochloride placebo given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) and paclitaxel 175mg/m^2 D1 q3w, carboplatin AUC 5mg/mL/min D1 q3w.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS) evaluated by IRC
时间窗: up to 24 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause; IRC defined as Independent Review Committee.
次要结局
- PFS rate at month 6(up to 6 months)
- PFS rate at month 12(up to 12 months)
- OS rate at month 12(up to 12 months)
- OS rate at month 18(up to 18 months)
- Adverse Event (AE)(up to 24 months)
- Duration of Overall Response (DOR)(up to 24 months)
- Progression Free Survival (PFS) evaluated by investigator(up to 24 months)
- Overall Survival (OS)(up to 24 months)
- Overall Response Rate (ORR)(up to 24 months)
- Disease Control Rate（DCR）(up to 24 months)
- OS rate at month 6(up to 6 months)
- Serious Adverse Event (SAE)(up to 24 months)
- Abnormal laboratory test index(up to 24 months)