LIBRETTO-431: A Multicenter, Randomized, Open-Label, Phase 3 Trial Comparing Selpercatinib to Platinum-Based and Pemetrexed Therapy With or Without Pembrolizumab as Initial Treatment of Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

The reason for this study is to see if the study drug selpercatinib compared to a standard treatment is effective and safe in participants with rearranged during transfection (RET) fusion-positive non-squamous non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Participants who are assigned to the standard treatment and discontinue due to progressive disease have the option to potentially crossover to selpercatinib.

本研究旨在对比研究药物塞普替尼（selpercatinib）与标准治疗方案，评估二者在已发生远处转移的转染重排（RET）融合阳性非鳞状非小细胞肺癌（NSCLC）受试者中的有效性与安全性。接受标准治疗且因疾病进展中止治疗的受试者，可选择交叉使用塞普替尼进行治疗。