Table 2. Selected clinical trials of EGFR/ALK TKIs in NSCLC.
| Trial number with references | Trial design | Trial target | ORR (%) | PFS (months) | OS (months) |
|---|---|---|---|---|---|
| First-generation EGFR TKI | |||||
| WJTOG3405 (104) | Gefitinib vs. cisplatin plus docetaxel | EGFR exon 19 del and L858R | 62.1 vs. 32.2 | 9.2 vs. 6.3 | 30.9 vs. NR |
| UMIN-CTR No. C000000376 (105) | Gefitinib vs. carboplatin-paclitaxel | EGFR exon 19 del and L858R | 73.7 vs. 37.0 | 10.8 vs. 5.4 | 30.5 vs. 23.6 |
| NCT01310036 (106) | Erlotinib | EGFR exon 19 del and L858R | 74.1 | 11.0 | 31.0 |
| Second-generation EGFR TKI | |||||
| NCT00525148 (83) | Afatinib, EGFR exon 19 del/L858R vs. others | EGFR exon 19 del and L858R | 66 vs. 39 | 13.7 vs. 3.7 | 38.7/31.5 vs. 16.3 |
| NCT00525148, NCT00949650, NCT01121393 (82) | Afatinib, point mutation/duplication vs. de novo T790M vs. exon 20 insertion | EGFR T790M, G719, L861Q, S768I and other point mutations | 71.1 vs. 14.3 vs. 8.7 | 10.7 vs. 2.9 vs. 2.7 | 19.4 vs. 14.9 vs. 9.2 |
| NCT01774721 (85) | Dacomitinib vs. gefitinib | EGFR exon 19 del and L858R | 76 vs. 70 | 14.7 vs. 9.2 | Immature at data cut off |
| NCT01360554, NCT00769067 (84) | Dacomitinib vs. erlotinib | Mutated EGFR | 62.1 vs. 60.0 | 14.6 vs. 9.6 | 26.6 vs. 23.2 |
| Third-generation EGFR TKI | |||||
| NCT02094261 (107) | Osimertinib | EGFR T790M | 70 | 9.9 | 13.0 |
| NCT02151981 (108) | Osimertinib vs. platinum-pemetrexed | EGFR T790M | 71 vs. 31 | 10.1 vs. 4.4 | NR |
| NCT02296125 (109) | Osimertinib vs. gefitinib/erlotinib | EGFR exon 19 del and L858R | 80 vs. 76 | 18.9 vs. 10.2 | NR |
| NCT01526928 (90) | Rociletinib, T790M positive vs. negative | EGFR T790M | 59 vs. 29 | 13.1 vs. 5.6 | NR |
| First-generation ALK TKI | |||||
| NCT00932893 (110) | Crizotinib vs. pemetrexed/docetaxel | ALK rearranged | 65 vs. 20 | 7.7 vs. 3.0 | 20.3 vs. 22.8 |
| Second-generation ALK TKI | |||||
| NCT01685060 (111) | Ceritinib in patients previously treated with crizotinib | ALK rearranged | 38.6 | 5.7 | 14.9 |
| NCT01828099 (112) | Ceritinib vs. cisplatin/carboplatin | ALK rearranged | 72.5 vs. 26.7 | 16.6 vs. 8.1 | NR vs. 26.2 |
| NCT01871805 (113) | Alectinib in crizotinib-resistant patients | ALK rearranged | 48 | 8.1 | Immature at data cut off |
| NCT02075840 (114) | Alectinib vs. crizotinib in previously untreated patients | ALK rearranged | 82.9 vs. 75.5 | 25.7 vs. 10.4 | Immature at data cut off |
| NCT01449461 (115) | Brigatinib in previously crizotinib-treated vs. crizotinib-naïve patients | ALK rearranged | 72 vs. 100 | 13.2 vs. NR | Immature at data cut off |
| Third-generation ALK TKI | |||||
| NCT01970865 (116) | Lorlatinib | ALK rearranged | 46 | 9.6 | NR |
EGFR, epidermal growth factor receptor; ALK, anaplastic lymphoma kinase; TKI, tyrosine kinase inhibitor; NSCLC, non-small-cell lung cancer; ORR, overall response rate; PFS, progression-free survival; OS, overall survival; NR, not recorded.