Table 1.
Characteristics of RCTs
| Study | Design | No. | Patient | Intervention | Comparison | Median Follow-Up (Updated) |
|---|---|---|---|---|---|---|
| Mitsudomi et al., 201010 (WJTOG3405) |
Phase 3 | 172 | NSCLC harboring EGFR mutation (19del or L858R), 75 y or younger, stage IIIB/IV or rec, ECOG PS 0–1, treatment-naive |
Gefitinib | Cisplatin plus docetaxel | 81 d (59.1 mo)11 |
| Maemondo et al., 201012 (NEJ002) |
Phase 3 | 228 | NSCLC harboring EGFR mutation, 75 y or younger, stage IIIB/IV or rec, ECOG PS 0–1, treatment-naive |
Gefitinib | Carboplatin plus paclitaxel | 527 d (704 d)13 |
| Zhou et al., 201114 (OPTIMAL) |
Phase 3 | 154 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, stage IIIB/IV or rec, ECOG PS 0–2, treatment-naive |
Erlotinib | Carboplatin plus gemcitabine | 15.6 mo (25.9 mo)15 |
| Rosell et al., 201216 (EURTAC) |
Phase 3 | 174 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, stage IIIB/IV, ECOG PS 0–2, treatment-naive |
Erlotinib | Platinum-doubleta | 18.9 mo (Not described)17 |
| Wu et al., 201518 (ENSURE) |
Phase 3 | 217 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, stage IIIB/IV, ECOG PS 0–2, treatment-naive |
Erlotinib | Cisplatin plus gemcitabine | 27.1–28.9 mo |
| Sequist et al., 201319 (LUX-Lung 3) |
Phase 3 | 345 | Lung adenocarcinoma harboring EGFR mutation, 18 y or older, stage IIIB/IV, ECOG PS 0–1, treatment-naive |
Afatinib | Cisplatin plus pemetrexed | 16.4 mo (41 mo)21 |
| Wu et al., 201420 (LUX-Lung 6) |
Phase 3 | 364 | Lung adenocarcinoma harboring EGFR mutation, 18 y or older, stage IIIB/IV, ECOG PS 0–1, treatment-naive |
Afatinib | Cisplatin plus gemcitabine | 16.6 mo (33 mo)21 |
| Soria et al., 201825 (FLAURA) |
Phase 3 | 556 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, locally advanced, or metastatic, ECOG PS 0–1, treatment-naive |
Osimertinib | Gefitinib or erlotinib | 15.0 mo (35.8 mo)26 |
| Hosomi et al., 202027 (NEJ009) |
Phase 3 | 345 | Non-SCC NSCLC harboring EGFR mutation (exons19, 21, or 18), 20 y or older, stage IIIB/IV or rec, ECOG PS 0–1, treatment-naive |
Gefitinib plus CBDCA/PEM | Gefitinib | 45 mo |
| Noronha et al., 202028 | Phase 3 | 350 | NSCLC harboring EGFR mutation (exons19, 21, or 18), 18 y or older, stage IIIB/IV, ECOG PS 0–2, treatment-naive | Gefitinib plus CBDCA/PEM | Gefitinib | 17 mo |
| Seto et al., 201429 (JO25567) |
Phase 2 | 152 | Non-SCC NSCLC harboring EGFR mutation (19del or L858R), 20 y or older, stage IIIB/IV or rec, ECOG PS 0–1, treatment-naive |
Erlotinib plus bevacizumab | Erlotinib | 20.4 mo (34.7 mo)30 |
| Saito et al., 201931 (NEJ026) |
Phase 3 | 224 | non-SCC NSCLC harboring EGFR mutation (19del or L858R), 20 y or older, stage IIIB/IV or rec, ECOG PS 0–2, treatment-naive |
Erlotinib plus bevacizumab | Erlotinib | 12.4 mo (39.2 mo)32 |
| Stinchcombe et al., 201933 | Phase 2 | 88 | NSCLC harboring EGFR mutation (19del or L858R), stage IV, ECOG PS 0–1, treatment-naive | Erlotinib plus bevacizumab | Erlotinib | 33 mo |
| Nakagawa et al., 201934 (RELAY) |
Phase 3 | 449 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, stage IV, or rec, ECOG PS 0–1, treatment-naive |
Erlotinib plus ramucirumab | Erlotinib plus placebo | 20.7 mo |
| Wu et al., 201735 (ARCHER1050) |
Phase 3 | 452 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, stage IIIB/IV, ECOG PS 0–1, treatment-naive, no brain metastases |
Dacomitinib | Gefitinib | 22.1 mo (31.3 mo)36 |
| Yang et al., 201737 (CTONG0901) |
Phase 3 | 256 | NSCLC harboring EGFR mutation (19del or L858R), 18 y or older, advanced, or metastatic, ECOG PS 0–2, EGFR TKI naive |
Erlotinib | Gefitinib | 22.1 mo |
| Park et al., 201638 (LUX-Lung 7) |
Phase 2 | 319 | Lung adenocarcinoma harboring EGFR mutation, 18 y or older, stage IIIB/IV, ECOG PS 0–1, treatment-naive |
Afatinib | Gefitinib | 27.3 mo |
| Mok et al., 201750 (AURA3) |
Phase 3 | 419 | NSCLC harboring EGFR T790M resistant mutation, 18 y or older, locally advanced, or metastatic, ECOG PS 0–2, after first-line EGFR TKI therapy |
Osimertinib | Platinum-doubletb | 8.3 mo |
19del, exon 19 deletion; CBDCA, carboplatin; ECOG, Eastern Cooperative Oncology Group; PEM, pemetrexed; PS, performance status; RCT, randomized controlled trial; rec, recurrent disease; SCC, squamous cell carcinoma; TKI, tyrosine kinase inhibitor.
a
Cisplatin or carboplatin plus docetaxel or gemcitabine.
b
Cisplatin or carboplatin plus pemetrexed.