Study Phase, study design, and sample size Stage EGFR mutation status aCT, % receiving aCT Treatment regimen Primary end points Median follow-up (years) Outcome
BR 19 Phase 3, randomized, double-masked, placebo controlled (n=503) IB-IIIA Wild type and mutated, only 15 patients with mutation Optional, 17% Gefitinib vs placebo for 2 years DFS, OS 4.7 No difference in DFS or OS; EGFR mutation not prognostic
RADIANT Phase 3, randomized, double-masked, placebo controlled (n=973) IB-IIIA Positive by IHC or FISH, 161 with sensitizing mutation Optional, 52.9% Erlotinib vs placebo for 2 years DFS 3.9 No difference in DFS, OS data immature. No difference in DFS in EGFRm subset
SELECT Phase 2, single-arm, open-label (n=100) IA-IIIA All with sensitizing mutation As per staging, not reported Erlotinib for 2 years 2-year DFS 5.2 2-year DFS 88%
CTONG1104 Phase 3, randomized, open-label (n=222) II-IIIA All with sensitizing mutation Offered to chemotherapy arm, 50% Cisplatin+Vinorelbine for 4 cycles vs gefitinib for 2 years DFS 6.4 DFS longer in gefitinib arm, no difference in OS
ADAURA Phase 3, randomized, double-masked, placebo controlled (n=682) IB-IIIA All with sensitizing mutation Optional, 60% Osimertinib vs placebo for 3 years DFS for stage II-III 1.84 for osimertinib, 1.24 for placebo 2-year DFS 90% in osimertinib arm vs 44% in placebo arm