A Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
研究概览
简要总结
The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.
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
- •Histologically or cytologically confirmed squamous NSCLC
- •Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition
- •Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1
- •Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments
排除标准
- •Nonsquamous NSCLC
- •Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor
- •Previous chemotherapy for NSCLC
- •Major surgery or received any investigational therapy in the 4 weeks prior to randomization
- •Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
- •Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (Participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
研究组 & 干预措施
Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
干预措施: Necitumumab (Drug)
Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
干预措施: Paclitaxel (Drug)
Necitumumab +Paclitaxel+Carboplatin
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.
Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.
Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle.
The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
干预措施: Carboplatin (Drug)
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
干预措施: Paclitaxel (Drug)
Paclitaxel + Carboplatin
Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
时间窗: Baseline to Disease Progression or Death (Up to 24 Months)
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
次要结局
- Overall Survival (OS)(Randomization to Date of Death (Up to 24 Months))
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab(Pre-infusion Cycle 1, Day 1; Cycle 3, Day 1; Cycle 5; Day 1 (within 2 hours prior to beginning of infusion))
- Percentage of Participants With Anti Necitumumab Antibodies(Baseline to End of Cycle 6)
- Progression-Free Survival(Randomization to Progressive Disease or Death (Up to 24 Months))
- Percentage of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])(Baseline to Progressive Disease and/or Death (Estimated up to 24 Months))
- Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab(Cycle 1, Day 8 ; Cycle 2, Day 1; Cycle 3, Day 1;Cycle 4, Day1;Cycle 5, Day 1; Cycle 6, Day 1 (within 2 hours prior to beginning of infusion))
- Percent Change in Tumor Size (CTS)(Baseline to Progressive Disease or Death (Up to 24 Months))