A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 719
- 试验地点
- 255
- 主要终点
- Objective Response Rate (ORR) by Week 19
研究概览
简要总结
This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
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
- Double (Participant, Investigator)
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
- •Male and female patients age at least 18 years of age, or age of consent in the region.
- •Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
- •Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
- •Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
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.
- •Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
- •Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
- •Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
研究组 & 干预措施
Bevacizumab-Pfizer
Bevacizumab-Pfizer plus paclitaxel and carboplatin
干预措施: Bevacizumab-Pfizer (Drug)
Bevacizumab-Pfizer
Bevacizumab-Pfizer plus paclitaxel and carboplatin
干预措施: Paclitaxel (Drug)
Bevacizumab-Pfizer
Bevacizumab-Pfizer plus paclitaxel and carboplatin
干预措施: Carboplatin (Drug)
Bevacizumab-EU
Bevacizumab-EU plus paclitaxel and carboplatin
干预措施: Bevacizumab-EU (Drug)
Bevacizumab-EU
Bevacizumab-EU plus paclitaxel and carboplatin
干预措施: Paclitaxel (Drug)
Bevacizumab-EU
Bevacizumab-EU plus paclitaxel and carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Week 19
时间窗: 25 weeks
ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits.
次要结局
- Number of Participants With Neutralizing Antibody (NAb)(55 weeks)
- Duration of Response (DOR)(55 weeks)
- Survival Rate at 55 Weeks(55 weeks)
- Serum Concentration of Bevacizumab up to 1 Year(Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5)
- Number of Participants With Anti-Drug Antibody (ADA)(55 weeks)
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(55 weeks)
- Number of Participants With Treatment-Emergent Adverse Events(55 weeks)
- Progression Free Survival Rate at 55 Weeks(55 weeks)