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 |