Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With 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
- 681
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Determine whether the addition of CP- 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology.
详细描述
The study was discontinued on December 29, 2009 due to an analysis by an independent Data Safety Monitoring Committee indicating that the addition of CP-751,871 [figitumumab] to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone. The DSMC recommendation to terminate the trial was based on futility, not on specific safety concerns; however, the DSMC recommended to investigate hyperglycemia as a potential contributor to the morbidity of the patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
- •Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
- •No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
- •Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
- •ECOG performance status (PS) 0 or 1.
排除标准
- •Patients with symptomatic central nervous system (CNS) metastases are not permitted.
- •Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
- •Patients with other active cancer types are not permitted.
研究组 & 干预措施
A
Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
干预措施: CP-751,871 (Figitumumab) (Drug)
A
Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
干预措施: Carboplatin (Drug)
A
Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.'
干预措施: Paclitaxel (Drug)
B
Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
干预措施: Carboplatin (Drug)
B
Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Baseline until death, assessed monthly after end of treatment, up to 30 months
Overall survival was the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact.
次要结局
- Maximum Observed Plasma Concentration (Cmax) for Figitumumab(Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose)
- European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) Score(Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months)
- Progression-Free Survival (PFS)(At baseline, every 6 weeks until radiological disease progression or the participant begins a subsequent anticancer therapy, up to 22.7 months.)
- Minimum Observed Plasma Trough Concentration (Cmin)for Figitumumab(Cycle 1, Day 1 (predose and 1 hour after end of infusion); Day 1 of Cycles 2, 4, 6 (predose); Cycle 5 Day 1 (predose, 1 hour after end of infusion); 28 days and 150 days after the last figi dose)
- Percentage of Participants With Objective Response (OR)(At baseline, every 6 weeks until radiological disease progression has been documented or the participant begins a subsequent anticancer therapy, up to 22.7 months)
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)(Day 1 of every cycle (3-week cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months)
- Euro Quality of Life (EQ-5D)- Health State Profile Utility Score(Day 1 of every cycle (3-weeks cycle), every 3 weeks during maintenance phase and at the End of Treatment Visit, assessed up to 37.4 months)
- Number of Participants With Total Anti-drug Antibodies (ADA)(Cycles 1, 2, and 4 (predose); 28 days and 150 days after the last figi dose)
- Change From Baseline in Serum Insulin Growth Factor 1 (IGF1) Levels(Cycles 1 and 4 (predose) and at end of treatment)