NCT05169801已完成3 期
To Compare the Efficacy and Safety of BP102 in Combination With Paclitaxel/Carboplatin and Avastin® in Combination With Paclitaxel/Carboplatin in First-line Treatment of Advanced or Relapsed NSCLC - a Randomized, Double-blind, Positive Parallel Control, Multicentre Phase III Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a randomized, double-blind, positive parallel control, multicentre Phase III clinical trial, a clinical trial of biosimilar drugs, so the type of comparison is equivalence test.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Aged from 18 to 75 (including 18 and 75), male or female;
- •Patients with locally advanced and unresectable NSCLC that has been histologically or cytologically proven, metastatic, or recurrent NSCLC.
- •No previous systematic antitumor therapy for current stage diseases. If previous adjuvant therapy has been received, it is necessary to ensure that the interval between the end of adjuvant therapy and the first administration of this study is more than 6 months, and that all adjuvant treating-related toxic reactions have recovered.
- •Patients must be able to document the EGFR mutation and ALK fusion gene status, and ALK must be negative. Patients who have not previously been tested for EGFR and ALK genes should be tested during screening;
- •There must be at least one measurable lesion as a target (according to RECIST V1.1);
- •ECOG: 0~1;
- •Life expectancy ≥24 weeks;
- •Major organs' function well.
排除标准
- •Patients with non-small cell lung cancer of other pathological tissue types;
- •Tumor histology or cytology confirmed positive ALK fusion gene;
- •Patients with imaging evidence of tumor invasion of large blood vessels;
- •Patients with uncontrolled pleural effusion and pericardial effusion that require repeated drainage;
- •Patients with abdominal effusion;
- •During the screening period, chest CT showed tumor cavity formation, or CT scan was highly suspected of idiopathic pulmonary fibrosis, mechanized pneumonia, drug-associated pneumonia, idiopathic pneumonia or active pneumonia;
- •Patients with hypertension whose blood pressure has not been satisfactorily controlled by antihypertensive drugs, and patients with previous hypertensive crisis or hypertensive encephalopathy;
- •Have heart disease or clinical symptoms that are not well controlled;
- •Patients with unhealed wounds, active gastric ulcers or fractures;
- •Patients diagnosed with esophagotracheal fistula;
- •People with known hereditary bleeding tendency or coagulation disorder;
- •Patients with known central nervous system metastases.
研究组 & 干预措施
Treatment group A
Experimental
干预措施: BP102, paclitaxel, carboplatin (Drug)
Treatment group B
Active Comparator
干预措施: Avastin®, paclitaxel, carboplatin (Drug)
结局指标
主要结局
Objective response rate
时间窗: 18 weeks
optimal ORR at 18 weeks, independent radiographic assessment
次要结局
- Incidence of treatment-emergent adverse events, serious adverse events(Enrollment to 28 days after permanent treatment termination)
- Overall survival (OS)(41 months)
- Disease Control Rate (DCR)(41 months)
- Positive rate of anti-bevacizumab antibody and its titer(41 months)
- Positive rate of neutralizing antibody(41 months)
- Progression-free survival(41 months)
- Duration of Response (DoR)(41 months)
- Quality of Life assessment using EORTC QLQ-C30(41 months)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
1 期
A Study of BN102 in Patients With Previously Treated CLL/SLL and B-cell NHLCLL/SLLNHLNCT05365100BioNova Pharmaceuticals (Shanghai) LTD.
进行中（未招募）
3 期
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)Multiple SclerosisNCT04548999Hoffmann-La Roche769
已完成
2 期
Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese SubjectsCentral Abdominal BulgingNCT02568319Neothetics, Inc120
终止
2 期
Phase 2 Study for SAR443820 in Participants With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral SclerosisNCT05237284Sanofi305
终止
2 期
A Phase 2 Study to Evaluate the Efficacy and Safety of SAR444656 Compared With Placebo in Adult Participants With Moderate to Severe Hidradenitis SuppurativaHidradenitis SuppurativaNCT06028230Sanofi70