Single-arm phase IIb trial evaluating sutetinib 80 mg orally once daily in adults with locally advanced or metastatic NSCLC harboring uncommon EGFR mutations (G719X, S768I, L861Q, or predefined compound mutations) with no prior EGFR-TKI therapy; median follow-up 16.6 months (n=96 efficacy-evaluable, n=99 safety).
IRC-confirmed ORR was 70.8% (95% CI 60.7–79.7); DCR 90.6%; median PFS 13.7 months; median DoR 12.0 months; median OS not reached. ORR was higher in compound vs. solitary mutations (84.4% vs. 64.1%). Grade ≥3 TRAEs in 42.4%, most commonly diarrhea (28.3%); no treatment-related deaths.
Single-arm design with no active comparator (e.g., afatinib or osimertinib), making cross-trial efficacy comparisons indirect. Heterogeneous mutation subtypes pooled together limit subgroup interpretation. Median OS not yet reached, leaving long-term survival data immature.
Sutetinib produced a ~71% response rate with a 13.7-month median PFS in uncommon EGFR-mutant NSCLC, supporting it as a viable first-line option in this hard-to-treat group. Monitor closely for diarrhea (grade ≥3 in 28%), which was the most common severe toxicity and drove dose reductions in one-third of patients.
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