drugset / Trial / NCT07182682

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

NCT07182682

Phase 3 Recruiting 360 enrolled Dizal Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-12-01
Primary completion
2029-09
Completion
2031-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunvozertinib Small molecule 200 mg Oral