A RANDOMIZED, DOUBLE-BLIND BRIDGING SAFETY AND EFFICACY STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF CHINESE PARTICIPANTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Percentage of Participants Achieving Objective Response
研究概览
简要总结
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.
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
- •Male and female participants age at least 18 years of age.
- •Newly diagnosed Stage IIIB, IIIC or IV non small cell lung cancer (NSCLC) (according to American Joint Committee on Cancer (AJCC) Staging Manual, 8th Edition, last updated 05 June 2018) or recurrent NSCLC.
- •Histologically or cytologically confirmed diagnosis of non-squamous NSCLC.
- •At least one measurable lesion as defined by RECIST v1.
- •Be eligible to receive 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.
- •Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that, in the opinion of the investigator, is likely to bleed.
- •Known EGFR activating mutations (for example, exon 19 deletion or exon 21 L858R substitution mutations) or ALK rearrangements.
- •Prior systemic therapy for advanced NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
研究组 & 干预措施
Arm A
PF-06439535 (CN) + paclitaxel + carboplatin
干预措施: PF-06439535 (CN) (Drug)
Arm A
PF-06439535 (CN) + paclitaxel + carboplatin
干预措施: Paclitaxel (Drug)
Arm A
PF-06439535 (CN) + paclitaxel + carboplatin
干预措施: Carboplatin (Drug)
Arm B
Bevacizumab-EU + paclitaxel + carboplatin
干预措施: Bevacizumab-EU (Drug)
Arm B
Bevacizumab-EU + paclitaxel + carboplatin
干预措施: Paclitaxel (Drug)
Arm B
Bevacizumab-EU + paclitaxel + carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants Achieving Objective Response
时间窗: From Week 1 to Week 25 (25 Weeks)
Objective response referred to 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 (non-progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions, normal nodes (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 Treatment-Emergent Adverse Events (TEAEs) in Treatment Period(From Day 1 to end of Cycle 8; 1 Cycle = 21 Days)
- Number of Participants With Anti-Drug Antibodies (ADA)(Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days)
- Number of Participants With NAb(Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 1 Cycle = 21 Days)
- Trough and Apparent Peak PF-06439535 (CN) and Bevacizumab (EU) Concentrations(Pre-dose on Day 1 of Cycle 1 and Cycle 5, and before the last administration of the investigational product (up to Cycle 14 Day 1); 2.5 hours after initiation of bevacizumab infusion on Day 1 of Cycle 1 and Cycle 5; 1 Cycle = 21 Days)
- Number of Participants With TEAEs in Extension Period(Cycle 9 Day 1 up to End of Treatment (up to Cycle 14 Day 21); 1 Cycle = 21 Days)