To Assess the Safety and Efficacy of Third-line and Above Therapy of Patients With Local Advanced or Metastatic NSCLC With Combined Treatment With Launched Recombinant Humanized Anti-PD-1 Monoclonal Antibody and Donafenib Tosilate
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- safety assessments
研究概览
简要总结
To assess the safety and efficacy of third-line and above therapy of patients with local advanced or metastatic non-small cell lung cancer (NSCLC) with combined treatment with launched recombinant humanized anti-PD-1 monoclonal antibody and Donafenib Tosilate
详细描述
Donafenib has a multi-target and dual anti-tumor effect, similar to sorafenib toluene sulfonate, and its effect is similar to that of sorafenib toluene sulfonate. Donafenib has the potential to be effective in the treatment of cancer, including advanced non-small cell lung cancer. PD-1 inhibitor has become a new therapy for advanced non-small cell lung cancer because of its strong specificity, definite efficacy, small side effects and long time of tumor control.
This is a single-center, open, single-arm, exploratory phase Ib trial. There were two dosages of donafenib (100mg qd and 100mg bid, respectively). Three to six subjects were enrolled in the dosages of 100mg qd. The investigators determined that the dosages of 100mg bid were well tolerated
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1、18 years age or older ,male or female
- •2、Histologically or cytologically confirmed diagnosis of local advanced or metastatic NSCLC
- •3、Previously received with two or more systemic Antitumor treatments (Chemotherapy or targeted therapy). Chemotherapy treatments must include a two-drug regimen containing platinum, patients with EGFR TKI drug resistance and unknow T790M mutation, after AZD9291 treatment patients with T790M mutation could be enrolled
- •4、At least one measurable lesion as defined by RECIST 1.
- •A previously irradiated site lesion may only be counted as a target lesion if there is clear sign of progression since the irradiation
- •5、Asymptomatic patients with uncontrolled brain metastases or brain metastases involving the pia mater
- •6、Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ 2 (CTCAE v5.0). AE of Neurology must be ≤ 1
- •7、Life expectancy ≥ 12 weeks
- •8、ECOG performance status 0-1
排除标准
- •Small cell lung cancer (including small lung cancer mixed with non-small cell lung cancer)
- •Patients at risk of bleeding treated with antiangiogenic drugs
- •Subjects who are using immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes (dose >10mg/ dprednisone or other therapeutic hormones) and who continue to use it for 2 weeks prior to enrollment
- •Patients with active, known or suspected autoimmune diseases, including tuberculosis, HIV infection, active hepatitis, etc.
- •Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radioactive pneumonia, drug-related pneumonia, severe impairment of lung function, etc
- •Women who are pregnant or lactating, or who are unwilling to use contraception during the trial
研究组 & 干预措施
donafenib tablets 1
This is the dose group was given once a day. donafenib tablets 1 100mg qd dose group
干预措施: donafenib tablets (Drug)
donafenib tablets 2
This is the dose group was given twice a day. donafenib tablets 2 100mg bid dose group
干预措施: donafenib tablets (Drug)
结局指标
主要结局
safety assessments
时间窗: From signing ICF to 30 days after the end of treatment
safety assessments
次要结局
- Disease control rate(Continue treatment until the end of treatment，an average of 12 months)
- Effective evaluation(Continue treatment until the end of treatment，an average of 12 months)
- Overall response rate(Continue treatment until the end of treatment，an average of 12 months)
研究者
Zhou Jianying
Chief physician
First Affiliated Hospital of Zhejiang University