Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.
Curr Opin Oncol. 2018 Mar;30(2):92-97. doi: 10.1097/CCO.0000000000000433.
Contemporary advances in the understanding of the molecular and immunologic basis of metastatic lung cancer have firmly changed its treatment paradigm to a personalized, biomarker-driven approach. However, the majority of lung-cancer patients [especially lung squamous cell carcinoma (LUSC)] still do not have effective targeted therapeutic options. Master protocols, such as Lung-MAP, represent an innovative clinical trial approach designed to accelerate evaluation of novel biomarker-driven therapies.
Lung-MAP is an umbrella trial for advanced LUSC and has been active since 2014. Cumulative experience from this overarching, multi-institution master protocol has demonstrated that centralized, real-time biomarker screening is feasible and substudy modularity is essential for protocol adaptability in a rapidly changing treatment landscape. In addition, screening and efficacy results from Lung-MAP affirm that LUSC has several putative drivers but remains difficult to effectively treat with targeted therapy.
Master protocols are a feasible and efficient approach for evaluating biomarker-driven therapies in lung cancer. As we begin to target less common genomic and immunotherapy subtypes, centrally coordinated clinical trial designs such as Lung-MAP are necessary to rapidly deliver effective therapies to patients, whereas also maximizing the quality of research data obtained.
对转移性肺癌分子和免疫基础的理解的当代进展已将其治疗模式牢固地转变为个性化的、基于生物标志物的方法。然而，大多数肺癌患者[尤其是肺鳞状细胞癌 (LUSC)]仍没有有效的靶向治疗选择。主方案（如 Lung-MAP）代表了一种创新的临床试验方法，旨在加速新型生物标志物驱动疗法的评估。
Lung-MAP 是一项针对晚期 LUSC 的伞式试验，自 2014 年以来一直活跃。从这个总体多机构主方案中积累的经验表明，集中的实时生物标志物筛选是可行的，并且子研究的模块性对于在快速变化的治疗环境中适应方案至关重要。此外，来自 Lung-MAP 的筛选和疗效结果证实，LUSC 有几个假定的驱动因素，但仍难以用靶向治疗有效治疗。
主方案是评估肺癌中基于生物标志物的治疗方法的可行且有效的方法。随着我们开始针对不太常见的基因组和免疫治疗亚型，像 Lung-MAP 这样的集中协调的临床试验设计对于向患者快速提供有效治疗方法是必要的，同时还最大限度地提高了获得的研究数据的质量。
