Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

Summary

This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.

Timeline

Start

2022-05-24

Primary completion

2025-06-01

Completion

2025-07-23

Publications

• Yue D, Huang M, Song P, Chen Y, Li B, Fu J, Guo J, Cheng C, Chen Q, Xu S, Liu H, Lv F, Hu J, Jiang K, Mao W, Shen B, Ye F, Li J, Zhang X, Guo S, Yu B, Zhu Y, Wu M, Zheng W, Chen F, He Z, Bai Y, Xin H, Chen K, Mao N, Zhang Y, Wang B, Zhang L, Chen X, Mei X, Miao L, Wang R, Li G, Yao J, Zhao J, Chen C, Liu J, Wei L, Yan X, Jin B, Liu X, Liu Z, Tian H, Xing W, Yang L, Ge D, Li X, Li S, Song Y, Zang A, Zhang D, Zhuang W, Liu Z, Yuan X, Fu T, Shen Z, Zhang X, Cao Q, Zhao L, Mao L, Ding L, Lu Y, Wang C; ELEVATE Study Group. Ensartinib in Resected ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2026 Jul 9;395(2):151-161. doi: 10.1056/NEJMoa2518990.

Drugs

Indications