In a multinational Phase 3 trial, Dizal Pharmaceuticals’ sunvozertinib outperformed chemotherapy (carboplatin–pemetrexed) as first-line treatment for advanced NSCLC with EGFR exon 20 insertion mutations. The study met its primary endpoint with a longer median progression-free survival by blinded independent central review. Across 324 randomized patients, median PFS was 10.3 months on sunvozertinib versus 7.5 months on chemotherapy (hazard ratio 0.65; P<0.001). The objective response rate was 58.9% versus 31.1% respectively, with response duration favoring sunvozertinib as well. Higher-grade adverse events were more frequent on sunvozertinib, including increased serum creatine kinase levels, diarrhea, and anemia. No deaths were attributed to investigator-assessed sunvozertinib-related events, supporting a favorable benefit-risk profile for a population historically constrained by limited targeted options.