Phase II, Single-Arm Study Of Carboplatin, Weekly Taxane, And Ramucirumab In Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After Progressive Disease On Maintenance Pemetrexed And/Or Pembrolizumab
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- To estimate overall response rate
研究概览
简要总结
The purpose of this study is to determine if the combination of the three anti-cancer drugs carboplatin, paclitaxel, and ramucirumab is helpful in shrinking tumors or delaying tumor growth in participants with non-small cell lung cancer. This study will also assess whether it is safe to combine these drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Advanced non-squamous NSCLC (Stage IV or recurrent after initial curative intent therapy) in adults age 18 or older
- •Prior exposure to 4-6 cycles of Pem/Carbo/Pembro and PD after at least 18 weeks of maintenance Pemetrexed, Pembrolizumab or the combination of the two.
排除标准
- •Presence of a driver mutation that is susceptible to targeted therapy
- •Other active invasive malignancy requiring ongoing therapy
- •Grade 2 or higher sensory neuropathy
- •Evidence of untreated brain metastases
- •History of bleeding diatheses or recent, antecedent hemoptysis (> 1/2 teaspoon in prior 2 months)
研究组 & 干预措施
Carboplatin, Taxane And Ramucirumab
Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks
干预措施: Carboplatin (Drug)
Carboplatin, Taxane And Ramucirumab
Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks
干预措施: Paclitaxel (Drug)
Carboplatin, Taxane And Ramucirumab
Carboplatin AUC 5 IV every 3 wks, Paclitaxel 80 mg/m2 IV days 1 and 8 every 3 weeks, and Ramucirumab 10 mg/kg IV every 3 weeks
干预措施: Ramucirumab (Drug)
结局指标
主要结局
To estimate overall response rate
时间窗: 3 years
Overall response rate (ORR) as determined by RECIST criteria. Response will be defined by a complete response (CR) or partial response (PRO), confirmed or unconfirmed.
次要结局
- Progression-free survival(From first dose of study drug until progressive disease, death or last assessment contact, whichever comes first, an average of 1-2 years)
- Overall Survival(from the first dose of study drug until death, last observation or contact, an average of 1-2 years)
- Safety Evaluations: number of Grade ≥ 3 as determined by CTCAE v 5.0(Initiation through 30 days following the last administration of study treatment.)