Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Summary
This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.
Timeline
- Start
- 2019-07-09
- Primary completion
- 2024-07-29
- Completion
- 2026-12
Outcome
Met primary endpoint
registry analysis (superiority test); Part B Dose Extension Cohort 1: EGFR exon20ins, Previously Treated; Sunvozertinib 200 mg; p <0.0001; binomial exact test against H0 NCT03974022 ↗
registry analysis (superiority test); Part B Dose Extension Cohort 2: EGFR exon20ins, Previously Treated; Sunvozertinib 300 mg; p <0.0001; binomial exact test against H0 NCT03974022 ↗
paper The predefined null hypothesis was rejected with statistical significance (P < .0001). PMID 40923280 ↗
release “WU-KONG1B met its primary endpoint, with the preliminary results featured as an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.” dizalpharma.com ↗
Publications
- Yang JC, Wang M, Doucet L, Fan Y, Lv D, Sun M, Huang D, Greillier L, Planchard D, Hong Q, Mazieres J, Felip E, Li X, Hu Y, Fang J, Bazhenova L, Ghiringhelli F, Cobo Dols MA, Rodriguez LP, Bearz A, Pellini B, Kim YJ, Bosch-Barrera J, Shim BY, Luo YH, Tiseo M, Yang TY, Carcereny E, Memmott RM, Zalcman G, de Castro Carpeno J, Di Noia V, Parra HS, Streich G, Lee DH, Shum E, Han JY, Jaime JC, Brungs D, John T, D'Arcangelo M, Joaquin AB, Liu G, Antonuzzo L, Hinojal GF, Le X, Zheng L, Janne PA; WU-KONG1B. Phase II Dose-Randomized Study of Sunvozertinib in Platinum-Pretreated Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 20 Insertion Mutations (WU-KONG1B). J Clin Oncol. 2025 Oct 10;43(29):3198-3208. doi: 10.1200/JCO-25-00788. Epub 2025 Sep 9.
- Miyamura BV, Mambetsariev I, Fricke J, Arias-Romero J, Cadman K, Shrestha S, Pisick E, Nguyen D, Malhotra J, Reyes A, Salgia R. Current paradigm of EGFRins20 in non-small cell lung cancer: A long way forward. Med. 2025 Sep 12;6(9):100803. doi: 10.1016/j.medj.2025.100803. Epub 2025 Aug 8.
- Luan T, Lin X, Xie X, Yang G, Wang S, Hao J, Zhou C. First case report of sunvozertinib for the treatment of HER2 exon 20 insertion in lung adenocarcinoma. Anticancer Drugs. 2024 Sep 1;35(8):757-760. doi: 10.1097/CAD.0000000000001628. Epub 2024 Jun 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sunvozertinib | Small molecule | 200 mg | Oral |
| Subject | Sunvozertinib | Small molecule | 300 mg | Oral |