AK112 in Advanced Non-Small Cell Lung Cancer

Summary

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.

Timeline

Start

2022-11-09

Primary completion

2024-01-29

Completion

2026-12-31

Publications

• Wang L, Yao W, Shen H, Xie C, Chen H, Chen K, Su W, Gan X, Zhuo M, Chen E, Xu Z, Zhang Y, Wang M, Ma R, Wu H, Zhang Z, Ye F, Moore AC, Zhou C. Plain language summary: comparing ivonescimab with pembrolizumab in people with PD-L1-positive non-small cell lung cancer in the HARMONi-2 study. Future Oncol. 2026 Jan;22(1):27-36. doi: 10.1080/14796694.2025.2601138. Epub 2025 Dec 28.
• Xiong A, Wang L, Chen J, Wu L, Liu B, Yao J, Zhong H, Li J, Cheng Y, Sun Y, Ge H, Yao J, Shi Q, Zhou M, Chen B, Han Z, Wang J, Bu Q, Zhao Y, Chen J, Nie L, Li G, Li X, Yu X, Ji Y, Sun D, Ai X, Chu Q, Lin Y, Hao J, Huang D, Zhou C, Shan J, Yang H, Liu X, Wang J, Shang Y, Mei X, Yang J, Lu D, Hu M, Wang ZM, Li B, Xia M, Zhou C. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China. Lancet. 2025 Mar 8;405(10481):839-849. doi: 10.1016/S0140-6736(24)02722-3.

Drugs

Indications