Table 2.
Study Characteristics of Nonrandomized Trials
Study | Design | No. | Patient | Intervention | Median Follow-Up, mo |
---|---|---|---|---|---|
Inoue et al., 200939 (NEJ001) |
Phase 2 | 30 | NSCLC harboring EGFR mutation (19del, L858R, L861Q, or G719X), stage IIIB/IV or rec, poor ECOG PS (20–74 y with PS 3–4, 75–79 y with PS 2–4, and 80 y or older with PS 1–4), treatment-naive |
Gefitinib | 17.8 |
Maemondo et al., 201240 (NEJ003) |
Phase 2 | 31 | NSCLC harboring EGFR mutation (19del, L858R, L861Q, or G719X), stage IIIB/IV or rec, 75 y or older, ECOG PS 0–2, treatment-naive | Gefitinib | 27.5 |
Yang et al., 201546 (LUX-lung 2,3,6) |
Pooled | 75 | Lung adenocarcinoma harboring EGFR uncommon mutation (group 1; point mutation or duplications in exon18–21, group 2; de novo T790M, group 3; exon 20 insertion), 18 y or older, stage IIIB/IV, ECOG PS 0–1, treatment-naive |
Afatinib | 34.7 |
Cho et al., 202047 (KCSG-LU15-09) |
Phase 2 | 37 | NSCLC harboring EGFR mutation (other than 19del, L858R, T790M, or exon 20 insertions), metastatic or rec, 19 y or older, ECOG PS 0–2, EGFR TKI naive |
Osimertinib | 20.6 |
Ramalingam et al., 201849 (AURA) |
Phase 1 | 60 | NSCLC harboring EGFR mutation (including T790M), locally advanced or metastatic, 18 y or older, WHO PS 0–1, treatment-naive | Osimertinib | 19.1 |
19del, exon 19 deletion; ECOG, Eastern Cooperative Oncology Group; PS, performance status; rec, recurrent disease; TKI, tyrosine kinase inhibitor.