A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients With Advanced/Recurrent Non Squamous NSCLC in Combination of Paclitaxel and Carboplatin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 731
- 试验地点
- 147
- 主要终点
- Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)
研究概览
简要总结
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
- •Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
- •Existence of at least 1 measurable lesion by RECIST v1.1
- •Adequate hematological, renal and liver function
- •Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1
- •Life expectancy longer than 6 months
排除标准
- •Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature
- •Any unresolved toxicities from prior systemic therapy
- •Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK) translocation positive mutations
- •Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
- •Known hypersensitivity to any excipients of the Investigational Products (IPs) and combination chemotherapy
- •Use of prohibited concomitant medication
- •Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
- •Fertile men or women of childbearing potential not using adequate contraception.
- •Other inclusion/exclusion criteria may apply.
研究组 & 干预措施
FKB238 / paclitaxel / carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: FKB238 (bevacizumab) (Drug)
FKB238 / paclitaxel / carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: Paclitaxel (Drug)
FKB238 / paclitaxel / carboplatin
Drug: FKB238:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: Carboplatin (Drug)
Avastin / paclitaxel / carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: Avastin (bevacizumab) (Drug)
Avastin / paclitaxel / carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: Paclitaxel (Drug)
Avastin / paclitaxel / carboplatin
Drug: Avastin:
15 mg/kg IV infusion on Day 1 of each 21-day cycle.
Drug: Paclitaxel:
200 mg/m2 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
Drug: Carboplatin:
AUC = 6.0 IV infusion on Day 1 of each 21-day cycle for at least 4 and no more than 6 cycles.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR)
时间窗: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.
The primary variable in this study was ORR, defined as the proportion of patients with a BOR of CR or PR (by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)). A BOR was defined as the best response (in the order of CR, PR, stable disease (SD), no evidence of disease (NED), progressive disease (PD), and not evaluable (NE)) among all post-baseline disease assessments that occurred until progression, or last evaluable assessment in the absence of progression prior to the initiation of subsequent anti-cancer therapy, irrespective of whether or not patients discontinued the study treatment. The 95% Pearson-Clopper confidence interval (CI) of ORR for each treatment arm was provided. Per RECIST v1.1 for target lesions and assessed by computed tomography (CT) or, if contraindicated, magnetic resonance imaging (MRI): CR=disappearance of all target lesions; PR=at least 30% decrease from baseline in the sum of diameters of target lesions. Overall Response=CR+PR.
次要结局
- Progression-free Survival (PFS)(Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.)
- ORR at Week 19(From the date of randomization up to Week 19.)
- Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED(Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.)
- Overall Survival (OS)(Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.)
- Duration Of Response (DOR)(Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.)