A Multi-centric, Open-label, Phase II Study Investigating the Combination of Afinitor With Paclitaxel and Carboplatin in First Line Treatment of Patients With Advanced (Stage IV) Large Cell Lung Cancer With Neuroendocrine Differentiation (LC-NEC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Percentage of Participants Progression-free
研究概览
简要总结
This is a multi-centric, open-label study evaluating the efficacy and safety of RAD001 in patients with advanced (stage IV) Lung Cancer (Large Cell) with neuroendocrine differentiation treated with a combination of RAD001 with paclitaxel and carboplatin.
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
- •Patients who give a written informed consent obtained according to local guidelines
- •Histologically confirmed diagnosis of stage IV lung cancer of LC-NEC type according to WHO classification:
- •Histolocial analysis of newly diagnosed disease must not be older than 8 weeks from signed consent
- •Relapse must be confirmed by histology
- •Neuroendocrine differentiation
- •World Health organisation (WHO) performance status grade ≤ 1
- •measurable disease
- •Adequate bone marrow function
- •Adequate liver function
- •Adequate renal function
排除标准
- •History or clinical evidence of central nervous system (CNS) metastases.
- •Presence of SCLC cells
- •Patients who have a history of another primary malignancy ≤ 3 years, with the exception of inactive basal or squamous cell carcinoma of the skin or cervical cancer in situ, early stages of breast cancer (LCIS and DCIS) and prostate cancer (stage T1a)
- •prior chemotherapy for the treatment of advanced lung cancer and/or not having recovered from the side effects of any other therapy (adjuvant treatment for earlier stages I-III is allowed if finished at least one year before study entry)
- •Patients who have received any investigational drug ≤ 28 days before starting study treatment or who have not recovered from side effects of such therapy
- •Patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study
- •Patients who have received prior therapy with RAD001 or other mTOR inhibitors
- •Having any severe and/or uncontrolled medical conditions
- •Women who are pregnant or breast feeding
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
RAD001 plus paclitaxel/carboplatin
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
干预措施: RAD001 (Drug)
RAD001 plus paclitaxel/carboplatin
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
干预措施: Paclitaxel (Drug)
RAD001 plus paclitaxel/carboplatin
Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Percentage of Participants Progression-free
时间窗: 3 months
Tumors were assessed according to Response Evaluation Criteria in Solid tumors (RECIST) to determine progression-free status. Complete response (CR): disappearance of all lesions (i.e. all evidence of disease, not just the target lesions) determined by 2 observations not less than 4 weeks apart; Partial response (PR): \> 30% decrease in the sum of longest diameters of target lesions compared to baseline, with response or stable disease observed in non-target lesions, and no new lesions; Stable disease (SD): neither sufficient shrinkage to qualify for response or sufficient increase to qualify for progressive disease in target lesions, with response or stable disease observed in non-target lesions, and no new lesions; Progressive disease (PD): \> 20% increase in the sum of longest diameters of target lesions compared to smallest sum longest diameter recorded. In addition, the sum must also demonstrate an absolute increase of at least 5mm.
次要结局
- Percentage of Participants With Overall Response Rate (ORR)(3 months)
- Progression Free Survival (PFS)(6 months)
- Percentage of Participants Progression-free(6 months)
- Overall Survival (OS)(12 months)
- Percentage of Participants With Disease Control Rate (DCR)(3 months)