Introduction
NSCLC, treatment-naive advanced ALK-positive NSCLC, Lung cancer, ALK-positive, lung cancer, anaplastic lymphoma
LUNG CANCER, MALIGNANT TUMORS, LUNG CANCER, ADENOCARCINOMA, NSCLC, CNS METASTASES
Lung cancer constitutes the most common malignant tumors around the world. Estimated 2,093,876 newly diagnosed lung cancer cases were reported in 2018 globally, with yearly age-standardized incidence rates of 31.5/100,000 in males and 14.6/100,000 in females.The oncogenic anaplastic lymphoma kinase (ALK) rearrangements occur in ~5–6% of NSCLC patients and are mostly observed in young individuals as well as in light or non-smokers with adenocarcinoma.ALK inhibitors have become the standard therapeutic option for advanced ALK-positive NSCLC.Envonalkib (CT-711, TQ-B3139, CTTQ Pharmaceutical Group Co., Ltd., Nanjing, China) is a newly developed small-molecule TKI against ALK, c-Met, and ROS1, which has a potency of five times higher than that of crizotinib in enzymatic assays.The present randomized phase III study aimed to compare envonalkib and crizotinib for efficacy and safety in patients with treatment-naive advanced ALK-positive NSCLC and to examine the effect of envonalkib against CNS metastases.