&NA; Treatment for lung cancer has evolved in the past 3 decades starting with platinum‐based chemotherapy as the standard of care, regardless of histology, in the early 1990s to the current age of biomarker‐driven therapy. Consequently, clinical trials in lung cancer have evolved in response to this new shift of paradigm, leading to novel approaches that simultaneously shorten the development process and allow evaluation of multiple patient cohorts. Herein, we provide an overview of the landscape of lung cancer clinical trials in the era of targeted therapies, precision medicine, and biomarkers. Specific trials are given as examples to illustrate the design paradigms. The paper is organized by drug development phases starting with early‐phase biomarker discovery to proof‐of‐concept trials to definitive trials. We also present some thoughts on future directions.

中文翻译：

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肺癌生物标志物临床试验：设计、物流、挑战和实际考虑

&NA; 肺癌的治疗在过去 3 年中不断发展，从 1990 年代初期以铂类化疗作为治疗标准开始，无论组织学如何，一直到目前生物标志物驱动治疗的时代。因此，肺癌的临床试验已经随着这种新的范式转变而发展，从而产生了同时缩短开发过程并允许评估多个患者队列的新方法。在此，我们概述了靶向治疗、精准医学和生物标志物时代肺癌临床试验的前景。给出了具体的试验作为例子来说明设计范式。该论文按药物开发阶段组织，从早期生物标志物发现到概念验证试验到最终试验。