Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 583
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).
详细描述
This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone.
This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.
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
- •Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.
排除标准
- •Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
- •Prior Erlotinib therapy.
- •Prior anti IGF IR based investigational therapy.
研究组 & 干预措施
Arm B
Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
干预措施: Erlotinib (Drug)
Arm A
The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.
CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
干预措施: CP 751,871 (Figitumumab) (Drug)
Arm A
The CP 751,871 treatment in combination with erlotinib will be given in three week cycles.
CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.
干预措施: Erlotinib (Drug)
结局指标
主要结局
Overall Survival
时间窗: Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months
The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.
次要结局
- Progression Free Survival (PFS)(Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months)
- Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)(Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group)
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)(Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose))
- Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)(Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose))
- Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab(Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group)
- Percentage of Participants With Objective Response(Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months)
- Maximum Observed Plasma Concentration (Cmax) for Figitumumab(Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group)
- Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)(Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose))
- Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)(Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose))