Table 3: Characteristics of the phase II trials included in the review: EGFR mutation testing as a predictor of response with erlotinib in the second- or third-line setting.

Author, year	Characteristics (%)	Design	Mutation of assessable treated patients (%)	Median PFS, ORR, OS [p-value]
				EGFR mutant vs. wild- type
Miller, 2008 (n=101)	Female 65% Never-smoker 42% Adenocarcinoma 88%	Multicenter, single-arm, two-stage, phase II	18/81 (22%)	PFS 13 vs. 2 months ORR 83% vs. 7% OS 23 months vs. 17 months
Schneider, 2008 (n=393) TRUST	Caucasian 99% Female 40% Adenocarcinoma 51% Never smoker 24% Second-line 80%	Open-label single-arm	6/91 (6.5) OR 6/195 (3.1%)	PFS HR, .31 (95%CI .13-0.78) ORR 33% vs. 3% OS HR, 0.33 (95%CI, 0.12 to 0.91)
Felip, 2008 (n=83)	Female 28% Adenocarcinoma 43% SCC 18% PS 0-1 Never-smoker 13%	Phase II	5/39 (13) All mutation from Adenocarcinoma	PFS 6.8 months vs. 1.4 months ORR 40% vs. 3% OS 6.8 months vs. 3.8 months
Ahn, 2008 (n=120)	All Asian Female 37% Adenocarcinoma 62% Never-smoker 39%	Phase II	24/92 (26%)	ORR 58% vs. 16%

Abbreviations: OS, overall survival; TTP, time to progression; DFS, disease free survival; PFS, progress free survival; NR: not reported; NS: not significant; ORR: objective response rate according to RECIST or ECOG criteria, comparing CR+PR; Wt: wild-type.