A Prospective, Randomized, Multicenter Real-world Study of Jinfukang Oral Liquid Combined With Chemotherapy in Treatment for Patients With Driver Gene-negative Advanced Non-small Cell Lung Cancer
试验速览
- 阶段
- 4 期
- 入组人数
- 328
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a prospective, randomized, multicenter real-world study, which aims to investigate the efficacy and safety of Jinfukang oral liquid combined with chemotherapy as first-line treatment regimen for patients with driver-negative advanced NSCLC. 328 patients with unresectable stage IIIB-IV NSCLC and Qi-Yin deficiency will be divided into experimental (n=164) and control groups (n=164) according to the stratified blocked randomization.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age;
- •Patients with stage ⅢB-IV NSCLC are diagnosed by histopathology and cytology;
- •Patients' tumor tissues are unresectable as assessed by the investigator;
- •Have measurable disease based on RECIST 1.1;
- •Driver gene (EGFR/ALK/ROS1) is negative;
- •Patients who are receiving first-line platinum-doublet chemotherapy with remaining no fewer than 4 therapeutic cycles;
- •Patients in chemotherapy who combined with other systemic therapy (including but not limited to immune checkpoint inhibitors and anti-vascular targeted drugs) are not suitable, but with radiotherapy can be permitted;
- •During chemotherapy cycles, patients who take prior treatment with anticancer Chinese medicine less than 4 weeks can be enrolled after stopping medication. If administration time is longer than 4 weeks, at least 4 weeks washout period should be performed;
- •Patients are diagnosed with Qi-yin deficiency by the Syndrome Differentiation of Traditional Chinese Medicine;
- •The expected survival time ≥3 months;
- •The subjects volunteer to sign the informed consent.
排除标准
- •Allergy or hypersensitivity to ingredients of the study treatment formulation;
- •Pregnant or lactating women;
- •Patients with multiple brain metastases, multiple bone metastases and liver metastases, which have great influence on survival times；
- •Patients are enrolling in other therapeutic trials;
- •The investigator does not consider the participant to be eligible for this study.
研究组 & 干预措施
Jinfukang oral liquid+Platinum-based doublet chemotherapy
The usage cycle of Jinfukang oral liquid will be consistent with platinum-based doublet chemotherapy. Jinfukang oral liquid will be taken at day 5 after chemotherapy, and will be taken continuously 3 times per day and 30 mL per time at least 4 cycles. The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".
干预措施: Jinfukang oral liquid (Drug)
Platinum-based doublet chemotherapy
The usage of platinum-based doublet chemotherapy will be performed following the details described at the "Primary Lung Cancer Diagnosis and Treatment Guidelines" and "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Non-small Cell Lung Cancer".
干预措施: Platinum-based doublet chemotherapy (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 18 months
Time from the start of treatment to first progression disease or death, whichever is earlier, according to RECIST 1.1 criteria.
次要结局
- Overall Survival (OS)(Up to 18 months)
- Objective Response Rate (ORR)(Up to 18 months)
- Disease Control Rate (DCR)(Up to 18 months)
- Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30)(Up to 18 months)
- Quality of Life as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 (EORTC QLQ-LC13)(Up to 18 months)
- Incidence and Severity of Adverse Events (AE)(Up to 18 months)
- Incidence and Severity of Serious Adverse Event (SAE)(Up to 18 months)
- Incidence and severity of Adverse Drug Reactions (ADR)，Serious Adverse Drug Reactions (SADR) or Suspected Unexpected Serious Adverse Drug Reactions (SUSAR)(Up to 18 months)
- Change from baseline of peripheral immune cell counts(Up to 18 months)