Table 1. Phase II trials with second generation EGFR-TKIs.
| TREATMENT | REFERENCE/ STUDY PHASE | PATIENTS | RESPONSES | SURVIVAL |
| Park K. 2010. (Phase I/II) |
54(previously treated with CT and EGFR inhibitors) | 15% PR 52.5% SD |
PFS 4 months 48% OS 6 months 87% |
|
| PF-299 | Campbell A. 2010. (Phase II) |
66 (previously treated with CT and erlotinib) | 4.6% PR 53% SD |
PFS 19.3 weeks (EGFR mutation) PFS 11.1 weeks (EGFR wild- type) |
| PF-299 vs. erlotinib | Boyer MJ. 2010 (Randomized phase II) |
188 (previously treated with CT, not with EGFR inhibitors) | ORR (PF-299) 17% ORR (erlotinib) 4% |
Median PFS (PF-299) 12.4 weeks PFS (erlotinib) 8.3 weeks |
| NERATINIB (HKI-272) | Sequist LV.2010. (Phase II) |
167 (previously and not previously treated with EGFR TKI) | 28% PR 36% SD ≥ 3 months |
Median PFS 15.3 weeks |
| Rizwi NA. 2008. (Phase II) |
41 (previously untreated, adenocarcinoma histology) | 28% PR 36% SD ≥ 3 months |
NA | |
| XL647 | Miller VA. 2008 (Phase II) |
34 (previously treated with EGFR TKI) | 3% PR 20.5% SD |
NA |
| BIBV2992 (Tovok) | Yang C. 2008 (Phase II) |
28 (previously treated) | ORR 50% | NA |
CT: chemotherapy; EGFR: epidermal growth-factor receptor; TKI: tyrosine-kinase inhibitor; PR: partial response; SD: stable disease; ORR: overall response rate; PFS: progression-free survival; OS: overall survival; NA: not available