Clinical Trial

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

Recruiting Phase 3
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Summary
To assess the efficacy and safety of sunvozertinib versus placebo as adjuvant therapy in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins) or P-loop and αC-helix compression (PACC) mutations, who have had radical surgery, regardless of adjuvant chemotherapy.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-12.
Status change: Not Yet Recruiting → Recruiting 2025-12-11
Trial Details
NCT Number NCT07182682
Lead Sponsor Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Conditions Non-Small Cell Lung Cancer
Enrollment 360 participants
Start Date 2025-12-01
Primary Completion 2029-09 (estimated)
Study Completion 2031-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-15