Phase 3 Study of Sunvozertinib vs Placebo as Additional Treatment After Surgery in Patients with Early-Stage Non-Small Cell Lung Cancer Having EGFR Exon 20 Insertion or PACC Mutations

What this Trial Is About

Researchers are evaluating the safety and effectiveness of sunvozertinib compared to a placebo as additional treatment after surgery in patients with early-stage non-small cell lung cancer NSCLC who have specific EGFR mutations called exon 20 insertion or PACC mutations. This phase 3 study includes patients who have had complete tumor removal and may or may not have received chemotherapy before. Participants will be randomly assigned to receive either sunvozertinib or a matching placebo taken orally once daily in 21-day treatment cycles. Treatment will continue until disease recurrence, unacceptable side effects, completion of three years of therapy, or other study endpoints such as withdrawal or death. The study is double-blind, meaning neither patients nor researchers know which treatment is given. During the trial, participants will be monitored regularly through evaluations including disease-free survival assessed up to approximately five years after the first patient is enrolled. Safety will be closely watched for up to three years, including tracking adverse events and measuring sunvozertinib levels in the blood. Participants will have surgery recovery and organ function assessed before starting treatment, and follow-up will continue long-term to understand treatment impact.

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