A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Summary

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage. Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).

Timeline

Start

2022-12-13

Primary completion

2026-01-16

Completion

2027-10-31

Publications

• Zhou C, Greillier L, Liu G, John T, Xing L, Kowalski D, Memmott RM, Yazici O, Sun M, Shu C, Pons-Tostivint E, Fan Y, Fernandez-Hinojal G, Shum E, Wang M, Bertolini F, Camidge DR, Zhou C, Doucet L, Hong Q, Fang J, Huang D, Jin B, Yu Y, Antonuzzo L, Moro-Sibilot D, Bennouna J, de Castro G Jr, Zheng L, Heymach JV; WU-KONG28 Investigators. First-Line Sunvozertinib in NSCLC with EGFR Exon 20 Insertion Mutations. N Engl J Med. 2026 May 29. doi: 10.1056/NEJMoa2604461. Online ahead of print.
• Wang M, Fan Y, Sun M, Wang Y, Zhao Y, Jin B, Hu Y, Han Z, Song X, Liu A, Tang K, Ding C, Liang L, Wu L, Gao J, Wang J, Cheng Y, Zhou J, He Y, Dong X, Yao Y, Yu Y, Wang H, Sun S, Huang J, Fang J, Li W, Wang L, Ren X, Zhou C, Hu Y, Zhao D, Yang R, Xu F, Huang Y, Pan Y, Cui J, Xu Y, Yang Z, Shi Y. Sunvozertinib for patients in China with platinum-pretreated locally advanced or metastatic non-small-cell lung cancer and EGFR exon 20 insertion mutation (WU-KONG6): single-arm, open-label, multicentre, phase 2 trial. Lancet Respir Med. 2024 Mar;12(3):217-224. doi: 10.1016/S2213-2600(23)00379-X. Epub 2023 Dec 12.

Drugs

Indications