NCT03703596Unknown2 期
Efficacy and Safety of Anlotinib Versus Docetaxel in Advanved Non-squamous Non-small-cell Lung Cancer Without EGFR Mutation Who Failed in First-line Platinum-based Doublet Chemotherapy: an Open, Muti-center, Randomized Controlled Trial
Sichuan Cancer Hospital and Research Institute10 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年10月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 88
- 试验地点
- 10
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of Vascular Endothelial Growth Factor Receptor 2（VEGFR）、FGFR（Fibroblast Growth Factor Receptor）, Platelet-derived growth factor Receptor（PDGFR） and c-kit, vs docetaxel in advanced Non-squamous Non-small cell lung cancer harbouring wild-type epidermal growth factor receptor (EGFR) .
详细描述
This is a multicentre randomised controlled clinical trial conducted in China to compare the efficacy and and safety of Anlotinib vs Docetaxel in patients of EGFR mutation-negative advanced nonsquamous non-small Cell Lung Cancer.
Eligible patients will be randomized to arm A and arm B:
Arm A: Patients on the anlotinib arm received 12mg anlotinib orally daily on day 1 to 14 of a 21-day cycle.
Arm B: Patients on the docetaxel arm received 75mg/m2 docetaxel as intravenous infusion on day 1 of a 21-day cycle.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-≥ 18 and ≤ 70 years of age. Signed the informed consent form prior to patient entry
- •Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV .
- •Histologically or pathologically confirmed non-squamous non-small cell lung cancer(NSCLC) with stage IV .
- •Patients who has failed from the first-line Platinum-based Doublet chemotherapy harbouring epidermal growth factor receptor(EGFR) sensitive mutations negetive, confirmed by pathological or blood test results) ）,ALK/ROS1 mutation-negative or unknown (For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment） Noted: failed from prior treatment means(1) progress disease confirmed by CT; cannot tolerable from standard treatment, such as hematologic toxicities ≥ level 4; non-hematologic toxicities ≥ level 3;damages of heart/liver/kidney ≥ level 2 in CTC AE 4.0
- •Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter imaged by CT scan or MRI；prior topical treatment, such as radiotherapy cryosurgery to the lesions is not allowed in less than 3 months;
- •Life expectancy ≥3 months.
- •Eastern Cooperative Oncology Group(ECOG) performance status 0 or
- •Toxicity caused by prior anti-cancer treatments was restored to ≤ level 1 in CTC AE (4.0) , except alopecia;
- •The blood routine examination need to be standard (no blood transfusion and blood products within 14 days, no g-csf and other hematopoietic stimulating factor correction); Hemoglobin（HB）≥90 g/L; A Neutrophil count of （ANC）≥1.5×10e9/L; A Platelet count of （PLT）≥80×10e9/L; A Total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); A alanine aminotransferase (ALT) and a aspartate aminotransferase (AST) of ≤2.5 UNL, in case of liver metastasis ALAT and ASAT≤5 UNL; A creatinine (Cr) of ≤1.5 UNL; a creatinine clearance rate ≥ 60ml/min (Cockcroft-Gault);
- •The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 8 weeks after it and examined as negative in blood serum test or urine pregnancy test within 7 days before the research; the man patients who must agree to take contraceptive methods during the research and within another 8 weeks Voluntarily joined the study and signed informed consent, with good compliance and follow-up.
排除标准
- •-Mixed Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer, adenocarcinoma mixed with squamous cell carcinoma
- •No squamous NSCLC with hemoptysis (>50ml/day);
- •Treated by taxel or similar drugs in 12months;
- •symptoms of brain metastases cannot be controlled and treated within less than 2 months
- •Tumor locate within a distance of less than 5 mm from the large vessels, less than 2 cm from the bronchial tree, or has invaded local large vessels; tumor with cavum or necrotic obviously;
- •Uncontrolled hypertension (systolic ≥140mmHg and/or diastolic ≥90mmHg, despite optimal drug therapy).
- •Patients with with grade Ⅱ myocardial ischemia or myocardial infarction, poor control of arrhythmias (including QTc interval male ≥ 450 ms, female ≥470 ms); according to NYHA standard, grade Ⅲ ~ Ⅳ heart failure, or cardiac color Doppler ultrasound examination showed left ventricular ejection fraction (LVEF) <50%.
- •Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment;note: Note: under the premise of International Normalized ratio (INR) of prothrombin time (PT) Less than or equal to 1.5, allow to administrate low-dose heparin (adult daily dose is 06000 ~ 12000 U) or low-dose aspirin (100 mg daily dosage or less) , for prophylactic purposes
- •Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
- •Patients whose has peripheral neuropathy over level 2 in CTC AE4.0, except trauma.
- •Patients with respiratory syndrome (difficulty breathing of level 2 or higher ), serous cavity effusion need to surgical treatment ( including pleural of level 2 or higher with respiratory distress and anoxia
- •Patients who have unhealed wounds or fractures for a long time.
- •Patients with severe infections , and need to receive systemic antibiotic treatment
- •Decompensated diabetes or other contraindication with high dose glucocorticoid therapy;
- •Cirrhosis or decompensated liver disease; active or untreated hepatitis C and/or Hepatitis B virus (HBV) infection（prior hepatitis B history, HBsAg positive and HBV DNA≥500IU/mL; HCV RNA positive and hepatic Insufficiency
- •Has an obvious factor influencing oral drug absorption, such as unable to swallow, chronic diarrhea and intestinal obstruction, etc
- •Patients who received major surgical operations or experienced severe traumatic injuries, bone fracture, or ulcers within 4 weeks before screening.
- •Severe weight loss (> 10%) Within 6 weeks before Random
- •Patients who had obvious hemoptysis (>50ml/day) within 3 months before screening; Patients who experienced bleeding symptoms of clinical significance within 3 months before screening, or with confirmed bleeding tendency such as hemorrhage of digestive tract, hemorrhagic gastric ulcer, baseline occult blood in stool ++ and above, or vasculitis, etc;
- •Patients who manifested arterial/venous thrombus events, e.g. cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening.
- •Allergic reactions to anotol or excipients in experimental drugs.
- •Allergic reactions to contrast medium
- •Patients have participated in other antitumor drug clinical trials Within 4 weeks before enrollment or prepare to receive systemic anti-tumor treatment during the study or Within 4 weeks before randomization
- •Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
研究组 & 干预措施
Anlotinib hydrochloric
Experimental
Anlotinib (12mg QD PO d1-14, 21 days per cycle)
干预措施: Anlotinib Hydrochloride (Drug)
Docetaxel
Experimental
Docetaxel (75mg/m2 IV d1, 21 days per cycle)
干预措施: Docetaxel (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to 24 months
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
次要结局
- Disease Control Rate (DCR)(Up to 24 months)
- Objective response rate(ORR)(Up to 24 months)
研究者
Jianing Tang
assistant of Medical Oncology Thoracic Department
Sichuan Cancer Hospital and Research Institute
研究点 (10)
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