美国国家癌症研究所最近发​​现，近年来非小细胞肺癌的死亡率总体下降了 6% 以上。死亡率的降低伴随着总体生存率的平均提高，这在很大程度上归功于非小细胞肺癌有效治疗的进步。在非小细胞肺癌中已经发现了许多分子改变，这使得能够开发出能够针对这些变化并有效杀死癌细胞的新药。调节患者免疫系统的新疗法已被证明可以有效刺激天然免疫细胞，从而提高抗癌效果。虽然这些类型的癌症治疗方法为患者提供了新的选择，但美国食品和药物管理局的领导层认识到，非小细胞肺癌靶向治疗的扩展带来了巨大的希望，但如果这些新药的安全性和有效性的评估将会放缓，尚未确定进行临床研究的新模型。具体来说，FDA 建议实施一种综合方法，根据肿瘤的分子特征来确定最适合这些疗法和其他新疗法的患者，并更有效地进行必要的临床研究，以评估这些疗法的安全性和有效性。新药。为了应对这一日益严峻的挑战，学术界、政府、行业和患者倡导领域的领先肺癌专家和利益相关者齐聚一堂，设计了一种临床研究方法，可以作为新型肺癌治疗的可持续基础设施，称为“肺癌主方案”。

National Cancer Institute recently found that death rates for non-small cell lung cancer have been reduced by over 6% overall in recent years. This reduction in mortality has been accompanied by an average increase in overall survival and largely credited to the therapeutic advancements for the effective treatment of NSCLC. Numerous molecular alterations have been identified in NSCLC that have enabled the development of new drugs capable of targeting these changes and efficiently kill cancerous cells. New treatments to modulate patient's immune systems have been shown to be effective in stimulating natural immune cells to have an improved anti-cancer effect. While these types of approaches to treat cancer are providing new options for patients, leadership from the Food and Drug Administration recognized that the expansion of targeted therapy in NSCLC presented significant promise, but evaluation of the safety and efficacy of these new drugs would be slowed if new models for conducting clinical studies were not identified. Specifically, FDA recommended that a comprehensive approach be implemented to identify the patients that are the best candidates for these, and other new treatments based upon the molecular characteristics of their tumors, and more efficiently conduct the clinical studies necessary to evaluate the safety and efficacy of new drugs. To address this growing challenge, leading lung cancer experts and stakeholders across academia, government, industry, and patient advocacy came together to design a clinical research approach that could serve as a sustainable infrastructure for new lung cancer treatments called the Lung Cancer Master Protocol.