QUILT-2.013 A Phase 1b/2 Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 213
- 主要终点
- Overall Survival in Ganitumab Treated Subjects -Phase 2
研究概览
简要总结
This trial is titled "A Phase 1b/2 trial of AMG 479 or AMG 102 with Platinum-Based Chemotherapy as First-Line Treatment for Extensive Stage Small-Cell Lung Cancer (SCLC)."
Part 1, the phase 1b portion of this study, is a multicenter, open-label investigation to identify safe dose levels of either AMG 102 or AMG 479 in combination with etoposide plus cisplatin or carboplatin in subjects with previously untreated extensive stage SCLC.
Part 2, the phase 2 portion of this study, is a multicenter, double-blind, 3-arm investigation to evaluate overall survival of either AMG 102 or AMG 479 in combination with platinum-based chemotherapy.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
干预措施: Etoposide (Drug)
ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
干预措施: AMG 479 (Drug)
ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
干预措施: Carboplatin (Drug)
ARM A
Blinded AMG 479 study drug and carboplatin or cisplatin and etoposide
干预措施: Cisplatin (Drug)
ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
干预措施: Etoposide (Drug)
ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
干预措施: AMG 102 (Drug)
ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
干预措施: Carboplatin (Drug)
ARM B
Blinded AMG 102 study drug and carboplatin or cisplatin and etoposide
干预措施: Cisplatin (Drug)
ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
干预措施: Etoposide (Drug)
ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
干预措施: Placebo (Drug)
ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
干预措施: Carboplatin (Drug)
ARM C
Blinded placebo and carboplatin or cisplatin and etoposide
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall Survival in Ganitumab Treated Subjects -Phase 2
时间窗: Time from randomization to death from any cause, approximately 14 months
The primary efficacy endpoint was overall survival, defined as time from randomization to death from any cause
Overall Survival in Rilotumumab Treated Subjects-Phase 2
时间窗: Time from randomization to death from any cause, approximately 14 months
The primary efficacy endpoint is overall survival, defined as time from randomization to death from any cause
Number of Subjects With Dose Limiting Toxicities-Phase 1
时间窗: First 21 days after start of study treatment
For Part 1, DLTs were defined as the incidence during the first 21 days of starting study treatment of any Grade 3 or higher hematologic or non-hematologic toxicity related to AMG 479 or AMG 102, or the combination of AMG 479 or AMG 102 with chemotherapy, except for lymphocytopenia and anemia. DLTs did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, increased AST or ALT, or pulmonary embolism unless specific criteria were met as stated in protocol section 6.1.3.2.
次要结局
未报告次要终点