Clinical Trial on the Survival Advantage of Kanglaite Injection (KLTi) in Advanced Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 334
- 试验地点
- 17
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Kanglaite Injection for advanced non-small cell lung cancer(NSCLC).
详细描述
This study include a multicenter, randomized, controlled post-market clinical trial.The randomized clinical trial will enroll approximately 334 patients. Participants will be randomly divided into experimental (n=167) and control groups (n=167).Patients in the experimental group will receive Kanglaite Injection combination with first-line chemotherapy based on NCCN Guidelines (2019.V3). Patients in the control group will receive first-line chemotherapy based on NCCN Guidelines (2019.V3).The primary endpoint is PFS(progression free survival).The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A Histological or cytological confirmed diagnosis of Stage III-IV NSCLC, with no history of anticancer treatment including chemotherapy;
- •Male or female aged 18-75years;
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2;
- •Life expectancy of at least 3 months;
- •At least one radiographically measurable lesion per RECIST 1.1;
- •Willing to join the clinic trail and sign informed consent;
- •Able to comply with scheduled visits and treatments.
排除标准
- •Presence of cerebral metastases;
- •Confirmed positive for expression of expression of epidermal growth factor receptor (EGFR), activin receptor-like kinase (ALK), c-ros oncogene 1 (ROS1) mutation, or programmed death-ligand 1 (PD-L1)(tumor proportion score [TPS≥ 50%] in a genetic test;
- •Participants with malignant pleural effusion underwent intrapleural injection chemotherapy;
- •Current undergoing or preparing for treatment with target therapy;
- •Current undergoing or preparing for radiotherapy to the thorax;
- •Current undergoing or preparing treatment with tumor immunotherapy;
- •Currently undergoing lipid-decreasing treament;
- •Pregnant or breastfeeding woman;
- •Fertile patients who are unwilling or unable to take effective contraceptive measures during the research period until 6 months after the study end later;
- •A history of mental disorders；
- •Severe and uncontrolled organic lesion or infection, including but not limited to cardiopulmonary failure and renal failure，which lead to poor tolerance of chemotherapy;
- •Participated in other clinical trials of small molecule research drugs within 28 days prior to enrollment, or participated in other clinical trials of large molecule research drugs within 3 months before enrollment;
- •Known allergy or intolerance to study medications;
- •Considered to be otherwise unsuitable for the clinical study by researchers.
研究组 & 干预措施
Kanglaite Injection + Chemotherapy
Participants receive Kanglaite Injection PLUS first-line chemotherapy.
干预措施: Kanglaite Injection+Chemotherapy (Drug)
Chemotherapy
first-line chemotherapy.
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: Randomization until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.
Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
次要结局
- One-Year Survival Rate(Randomization until One year.)
- Blood lipid(every 41-56 days(2 cycles ) until disease progression, death, or assessed up to 12 months after randomized enrollment.)
- Percentage of Participants With Adverse Events(Baseline until disease progression,death, or assessed up to 12 months after randomized enrollment.)
- Objective Response Rate (ORR)(Every two cycles (each cycle is 21-28 days) until disease progression, death, or 12 months after randomized enrollment, whichever occurs first.)
- Quality of life of the patient(before and after each cycle of treatment, assessed up to 12 months after randomized enrollment)
- Living ability of the patient(before and after each cycle of treatment, assessed up to 12 months after randomized enrollment)
研究者
Jie Li
Chief of Medical Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences