AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

Summary

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous 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 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.

Timeline

Start

2023-08-17

Primary completion

2025-02-28

Completion

2026-12-31

Publications

• Chen Z, Yang F, Jiang Z, Sun L, Wu L, Han Z, Fan Y, Zhao Y, Li X, Xu H, Meng X, Liu Y, Zhang Z, Luo H, Ma X, Ma X, Shi Q, Zhang Z, Yang R, Wang P, Pan P, Ai X, Li J, Pu X, Wang Z, Fang J, He M, He Y, Guo S, Li J, Wang H, Zhang J, Chu Q, Liu X, Ying S, Wu H, Sun H, Ji Y, Zhou M, Cao C, Tang K, Li Z, Li D, Zhang Z, Li J, Zhou J, Yang H, Du Y, Yang H, Shi J, Chen H, Moore AC, Lu S. Plain language summary: comparing ivonescimab plus chemotherapy with tislelizumab plus chemotherapy in people with advanced squamous non-small cell lung cancer in the HARMONi-6 study. Future Oncol. 2026 Jun 3:1-14. doi: 10.1080/14796694.2026.2676052. Online ahead of print.
• Lu S, Liu B, Luo Y, Sun L, Wu L, Han Z, Fan Y, Zhao Y, Li X, Xu H, Meng X, Liu Y, Zhang Z, Luo H, Ma X, Ma X, Shi Q, Zhang Z, Yang R, Wang P, Pan P, Ai X, Li J, Pu X, Wang Z, Fang J, He M, He Y, Guo S, Li J, Wang H, Zhang J, Chu Q, Liu X, Ying S, Wu H, Sun H, Ji Y, Zhou M, Cao C, Tang K, Li Z, Li D, Zhang Z, Li J, Zhou J, Yang H, Du Y, Yang H, Shi J, Chen H, Chen Z, Li W, Lu D, Hu M, Wang ZM, Li B, Xia MY. Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China. Lancet. 2026 Jun 27;407(10548):2620-2629. doi: 10.1016/S0140-6736(26)00966-9. Epub 2026 May 31.

Drugs

Indications