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首页> 外文期刊>Clinical lung cancer >Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer.
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Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer.

机译：突破性研究的治疗原理和研究设计：培美曲塞/卡铂/贝伐单抗的随机，开放标签III期研究，然后进行培美曲塞/贝伐单抗与紫杉醇/卡铂/贝伐单抗的维持治疗，对IIIB或IV期非鳞状非IV期患者进行贝伐珠单抗治疗-小细胞肺癌。

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摘要

We present the treatment rationale and study design of the PointBreak study, a phase III study of pemetrexed/ carboplatin/bevacizumab induction followed by pemetrexed/bevacizumab maintenance (arm A) compared with paclitaxel/carboplatin/bevacizumab induction followed by bevacizumab maintenance (arm B) in patients with advanced nonsquamous non-small-cell lung cancer (NSCLC). Treatment consists of up to 4 cycles of induction therapy followed by maintenance therapy until disease progression or treatment discontinuation in approximately 900 patients (450 per treatment arm). The efficacy objectives of this study are to compare overall survival (OS), response rates, disease control rates, progression-free survival, and time to progressive disease between the 2 treatment arms. In addition, safety, quality of life, pharmacokinetics, and translational research will be investigated for both treatment arms. If the primary objective (OS) is achieved, this study will provide robust results on an alternative treatment option, pemetrexed/carboplatin/bevacizumab followed by maintenance therapy with pemetrexed/bevacizumab, for patients with nonsquamous NSCLC.
机译：我们介绍了PointBreak研究的治疗原理和研究设计，该研究是培美曲塞/卡铂/贝伐单抗诱导后继培美曲塞/贝伐单抗维持治疗（A组）与紫杉醇/卡铂/贝伐单抗诱导再贝伐珠单抗维持治疗（B组）的III期研究在晚期非鳞状非小细胞肺癌（NSCLC）患者中。治疗由大约900个患者（每个治疗组450个）中的多达4个诱导治疗周期和随后的维持治疗组成，直至疾病进展或治疗中断。这项研究的功效目标是比较两个治疗组之间的总生存期（OS），反应率，疾病控制率，无进展生存期和进行性疾病的时间。此外，还将对两个治疗臂的安全性，生活质量，药代动力学和转化研究进行调查。如果实现了主要目标（OS），则本研究将为非鳞状NSCLC患者在培美曲塞/卡铂/贝伐单抗的替代治疗方案以及培美曲塞/贝伐单抗的维持治疗后提供可靠的结果。

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