A Phase 1b/2 Study of AMG 479 in Combination With Paclitaxel and Carboplatin for the First-Line Treatment of Advanced Squamous Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Part 1: Number of Dose Limiting Toxicities
研究概览
简要总结
This is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of AMG 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Histologically or cytologically confirmed advanced squamous NSCLC
- •Measurable disease as defined per modified RECIST criteria
- •ECOG performance status of 0 or 1
- •≥18 years old
- •Adequate glycemic function, for subjects with known diabetes
排除标准
- •Untreated or symptomatic central nervous system (CNS) metastases
- •Prior anti-cancer therapy as follows: Any prior chemotherapy for squamous NSCLC; Any prior adjuvant or neoadjuvant chemotherapy for squamous NSCLC; Any prior chemoradiation for squamous NSCLC; Central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous NSCLC
研究组 & 干预措施
Part 1 Cohort 1
AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1
干预措施: AMG 479 (Biological)
Part 1 Cohort 1
AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1
干预措施: Carboplatin (Drug)
Part 1 Cohort 1
AMG 479 at 18 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 18 mg/kg monotherapy for 24 months from study day 1
干预措施: Paclitaxel (Drug)
Part 1 Cohort 2
AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1
干预措施: AMG 479 (Biological)
Part 1 Cohort 2
AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1
干预措施: Carboplatin (Drug)
Part 1 Cohort 2
AMG 479 at 12 mg/kg in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 at 12 mg/kg monotherapy for 24 months from study day 1
干预措施: Paclitaxel (Drug)
Part 2
AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1
(AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)
干预措施: Carboplatin (Drug)
Part 2
AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1
(AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)
干预措施: AMG 479 (Biological)
Part 2
AMG 479 in combination with paclitaxel/carboplatin for 4 to 6 cycles followed by AMG 479 monotherapy for 24 months from study day 1
(AMG 479 dose in Part 2 will be the final AMG 479 dose from Part 1)
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Part 1: Number of Dose Limiting Toxicities
时间窗: Part 1 only up to 21 days
DLTs were defined as grade 3 or higher hematological or nonhematological toxicities that, in the opinion of the investigator, were related to ganitumab or the combination of ganitumab and paclitaxel or carboplatin during this period. These did not include fatigue, nausea, diarrhea, vomiting, hyperglycemia, neutropenia, thrombocytopenia, anemia, lymphopenia, alopecia, increased ALT or AST, or pulmonary embolism unless they met certain criteria.
Part 2: Objective Response Rate
时间窗: From start of treatment up to approximately 16 months
Part 2: Objective Response Rate as per modified RECIST criteria by investigator review Objective response was defined as a tumor response assessment of either complete response or partial response per modified Response Evaluation Criteria in Solid Tumors \[RECIST\] and was determined only for subjects with measurable disease at baseline. Per RECIST: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Number of Participants With Adverse Events(30 days after last dose, up to 5 months)
- Number of Participants With Anti-AMG 479 Antibody Formation(From start of treatment up to approximately 16 months)
- Progression Free Survival(From start of treatment up to approximately 16 months)
- Time to Progression and Duration of Response(From start of treatment up to approximately 16 months)