NCT04895930招募中2 期
A Multi-center, One-arm Clinical Trial of Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive Locally Advanced or Metastatic NSCLC.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The aim of this phase Ⅱ study is to evaluate the efficacy and safety of Furmonertinib combined with Anlotinib as the first-line treatment in locally advanced or metastatic non-small cell lung cancer with sensitive EGFR mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects have voluntarily participated, signed and dated informed consent;
- •Male or female subjects aged ≥18 and ≤75 years old;
- •Locally advanced or metastatic adenocarcinoma NSCLC confirmed by histology or cytology (according to the 8th Edition of the AJCC Staging system), not suitable for surgery or radiotherapy;
- •ECOG score 0-1, and life expectancy no less than 12 weeks according to the investigator's assessment;
- •The tumour harbours one of the most common EGFR mutations (19del or L858R) ;
- •According to RECIST 1.1, subjects have at least one measurable tumor lesion at baseline, and had not received radiotherapy previously;
- •No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC. For recurrent disease, adjuvant therapy or neoadjuvant therapy may be accepted, but recurrence occurs ≥6 months from stopping treatment;
- •Subjects with stable clinical symptoms of pleural effusion or ascites after symptomatic treatment;
- •For premenopausal women with fertility, the result of serum or urine pregnancy test should be negative within 7 days before the first dose.
排除标准
- •Not lung adenocarcinoma, including lung squamous carcinoma, or mixed histology, etc;
- •Subjects are expected to participate in other clinical studies during this trial period;
- •Imaging evidence showed that the tumor had invaded critical blood vessels;
- •Subjects who receive systemic anti-tumor therapy used for locally advanced or metastatic NSCLC previously;
- •With other malignant tumors at present or history of other malignant tumors within 5 years;
- •Leptomeningeal metastases or central nervous system metastasis requiring emergency treatment;
- •At the beginning of study treatment, any unresolved toxic reaction to prior treatment (e.g., adjuvant chemotherapy) exceeds CTCAE Grade 1;
- •History of ILD, drug-induced ILD, radiation pneumonitis which require steroid treatment, or with suspected clinical manifestations of ILD or high risk factors;
- •Severe gastrointestinal dysfunction may affect the intake, transport or absorption of the study drugs;
- •Recent active digestive diseases or other conditions that may cause gastrointestinal bleeding or perforation;
- •Presence of bleeding constitution or active bleeding; any bleeding event ≥CTCAE grade 3, unhealed wounds, ulcers, or fractures occurred within 28 days prior to the first dose;
- •Any of the following organ function criteria is met (no blood or blood product transfusions, no hematopoietic stimulating factors, no albumin or blood product transfusions within 7 days prior to examination): Absolute value of neutrophil (NE)<1.5 × 109/L, platelet (PLT) count<90 × 109/L, hemoglobin (HGB)<90 g/L; Serum total bilirubin (TBIL)>1.5 × ULN, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)>2.5 × ULN (for liver metastases or Gilbert Syndrome, TBIL>3 × ULN, and AST and/or ALT>5 × ULN); Serum creatinine (SCr)>1.5 × ULN, or creatinine clearance<60ml/min. (According to the Cockcroft and Gault formula); Urinary protein ≥ ++, or 24-hour urine protein>1.0g; International normalized ratio（INR）>1.5 and activated partial thromboplastin time (APTT)>1.5 ULN; Fasting blood glucose >10mmol/L；
- •Any of the following cardiac criteria is met：
- •At rest, the mean corrected QT interval (QTc) by ECG > 470 msec；
- •Seriously abnormal of heart rhythm, conduction, or morphology of resting ECG;
- •Any factors that may increase the risk of prolonged QTc or risk of arrhythmic events;
- •Left ventricular ejection fraction (LVEF) < 50%;
- •Uncontrollable hypertension (systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥100 mmHg);
- •With active infection diseases, such as HBV, HCV and HIV;
- •Known or suspected to be allergic to Furmonertinib and Anlotinib and / or other components of their preparations;
- •Pregnancy or lactation;
- •Subjects who are considered ineligible for the study for other reasons according to the investigator's assessment.
研究组 & 干预措施
Furmonertinib Plus Anlotinib
Experimental
Furmonertinib (80mg) plus Anlotinib (10mg)
干预措施: Furmonertinib (Drug)
Furmonertinib Plus Anlotinib
Experimental
Furmonertinib (80mg) plus Anlotinib (10mg)
干预措施: Anlotinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Approximately 3 years following the first dose of study drugs
Proportion of subjects whose tumors were assessed as complete response(CR) or partial response(PR) according to RECIST 1.1.
次要结局
- Duration of Response (DOR)(Approximately 3 years following the first dose of study drugs)
- Disease progression free survival (PFS)(Approximately 3 years following the first dose of study drugs)
- Adverse Events(Until 30 days from the last dose of study drugs or initiation of a new anticancer treatment)
- Disease Control Rate (DCR)(Approximately 3 years following the first dose of study drugs)
研究者
Baohui Han
Director of department
Shanghai Chest Hospital
研究点 (1)
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