Table 4. Phase III trials with EGFR TKI compared with placebo in 2nd- or 3rd-line.

Trial	Study population	Treatment	No. of pts	Median OS (months)	HR (95% CI)	Log-rank P	RR (%)
BR.21	Prior platinum	Erlotinib 150	731	6.7	0.70 (0.58–0.85)	<0.001	8.9
		Placebo		4.7			1.0
ISEL	Prior platinum	Gefitinib 250	1,692	5.6	0.89 (0.77–1.02)	0.087	8.0
		Placebo		5.1			1.3

EGFR, epidermal growth factor receptor; TKI, tyrosine-kinase inhibitor; OS, overall survival; HR, hazard ratio; RR, response rates.