Sunvozertinib
Sponsors
Dizal (Jiangsu) Pharmaceutical Co. Ltd., Dizal Pharmaceuticals, Sichuan University, Sun Yat-sen University, Henan Cancer Hospital
Conditions
Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion MutationLung Cancer Stage IIIMutationNSCLCNon Small Cell Lung CancerNon-Small Cell Lung CancerNon-small Cell Lung CancerPotentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer
Phase 1
Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)
Active, not recruitingNCT03974022
Start: 2019-07-09End: 2026-12-01Updated: 2026-01-29
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure:Phase I/II
RecruitingNCT06195189
Start: 2024-02-29End: 2026-02-01Target: 40Updated: 2024-03-25
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation
Active, not recruitingCTIS2024-512127-36-00
Start: 2022-03-31Target: 64Updated: 2025-06-26
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
RecruitingNCT06905197
Start: 2025-05-13End: 2028-12-01Target: 140Updated: 2026-02-27
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
RecruitingNCT07079475
Start: 2025-07-31End: 2029-12-31Target: 200Updated: 2025-12-24
Phase 2
Sunvozertinib (DZD9008) in Pretreated Lung Cancer Patients with EGFR Exon20 Insertion Mutation (WU-KONG6)
Active, not recruitingNCT05712902
Start: 2021-07-19End: 2025-12-31Updated: 2024-12-30
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.
RecruitingNCT06563999
Start: 2024-11-01End: 2029-11-01Target: 120Updated: 2024-12-10
Perioperative Treatment of Sunvozertinib in Stage II-IIIB NSCLC
RecruitingNCT06864624
Start: 2025-02-18End: 2029-06-30Target: 27Updated: 2025-07-25
Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.
Active, not recruitingNCT07274761
Start: 2024-10-17End: 2030-05-01Target: 24Updated: 2025-12-10
Phase 3
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)
Active, not recruitingNCT05668988
Start: 2022-12-13End: 2027-10-31Updated: 2026-02-17
A Phase 3, Open-Label, Randomized, Multi-Center Study of DZD9008 versus Platinum-Based Doublet Chemotherapy as First-Line Treatment for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Exon 20 Insertion Mutation
RecruitingCTIS2022-502959-54-00
Start: 2023-09-26Target: 65Updated: 2025-08-04
A Phase 3 Study of Sunvozertinib Versus Placebo as Adjuvant Therapy in Patients With Early-Stage Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations or PACC Mutations After Radical Surgery
RecruitingNCT07182682
Start: 2025-12-01End: 2031-01-31Target: 360Updated: 2025-12-15