A Phase I/II Study of Anlotinib Combined With Platinum-based Chemotherapy as the First-line Treatment of Patients With Locally Advanced or Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 主要终点
- Progress free survival (PFS)
研究概览
简要总结
Non-small cell lung cancer has the highest morbidity and mortality in China，and platinum-based chemotherapy is the standard first-line treatment for the wild-type NSCLC,however the overall survival still less than one year.Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit, which has strong effect of anti-angiogenesis.This study is aim to evaluate the efficacy and safety of the combination regimen of anlotinib plus platinum-based chemotherapy as first-line treatment for NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age：18~70 years;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 -2
- •Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC
- •EGFR\ALK\ROS1 wildtype or unknown,or patients with EGFR\ALK\ROS1 mutations but refuse to receive corresponding inhibitors' treatment
- •No indications for radiation therapy
- •Previously chemotherapy naive or postoperative adjuvant chemotherapy ended more than 1 year
- •Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI
排除标准
- •Small Cell Lung Cancer
- •central lung squamous carcinoma along with cavum, or non-small cell lung cancer along with hemoptysis (>50ml/day)
- •Within 30 days before enrollment, the patient had used any chemotherapy drugs in the previous treatment regimen or clinical study; Or, within 14 days before the first administration of the study therapy, the patient has used any targeted anticancer drugs in the previous treatment regimen or clinical study; Or stop other experimental drugs or cancer drugs for less than five half-life of the drug
- •Previous use of anti-angiogenic drugs (such as anlotinib, apatinib, bevacizumab, endostar, etc.)
- •have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
- •Spinal cord compression or symptomatic and untreated brain metastases (asymptomatic, stable, no need for steroid treatment for 4 weeks before study start)
- •with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus)
- •Previous histories include: interstitial pneumonia, drug-induced interstitial pneumonia, radiation pneumonia requiring steroid treatment, and clinically proven active interstitial pneumonia
- •get arterial/venous thrombosis within 6 months, such as cerebrovascular accidents (including temporary ischemic stoke), prevenous thrombosis, and pulmonary embolism
- •Have suffered from hemorrhagic disease or coagulation dysfunction
- •diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
研究组 & 干预措施
Non-squamous cell lung cancer
Anlotinib combined with pemetrexed and carboplatin, phase I
Anlotinib combined with pemetrexed and carboplatin, phase II
干预措施: Anlotinib combined with pemetrexed and carboplatin, phase I (Drug)
Non-squamous cell lung cancer
Anlotinib combined with pemetrexed and carboplatin, phase I
Anlotinib combined with pemetrexed and carboplatin, phase II
干预措施: Anlotinib combined with pemetrexed and carboplatin, phase II (Drug)
Squamous cell lung cancer
Anlotinib combined with paclitaxel and carboplatin, phase I
Anlotinib combined with paclitaxel and carboplatin, phase II
干预措施: Anlotinib combined with paclitaxel and carboplatin, phase I (Drug)
Squamous cell lung cancer
Anlotinib combined with paclitaxel and carboplatin, phase I
Anlotinib combined with paclitaxel and carboplatin, phase II
干预措施: Anlotinib combined with paclitaxel and carboplatin, phase II (Drug)
结局指标
主要结局
Progress free survival (PFS)
时间窗: From date of enrollment until the date of first documented progression or date of death from any cause,whichever came first.up to 12 months
progression free survival
次要结局
- Objective Response Rate (ORR)(each 21 days up to the toxicity or PD (up to 24 months))
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Safety)(Time Frame: each 21 days up to the toxicity or PD (up to 36 months))
- Disease Control Rate (DCR)(each 42 days up to intolerance the toxicity or PD (up to 24 months))
- Overall Survival (OS)(From enrollment until death (up to 36 months))
研究者
Shi Yuankai
Vice President of Cancer Hospital Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences