Table 4: Phase III trials with Gefitinib in “selected” NSCLC.

Author (yr)StudySettingPtsTreatmentRR (%)PFS (mos)OS (mos)

Mok et al. (2009) [57]IPASS1st line, clinically selected1217Gefitinib versus Carboplatin +
Paclitaxel
43 versus 32.3 ( )5.7 versus 5.8 HR: 0.74, 95% CI: 0.65–0.85, 18.6 versus 17.3 HR: 0.91, 95% CI: 0.76–1.10
Subgroup of EGFR mutated26171.2 versus 47.3 ( )9.5 versus 6.3 HR: 0.48, 95% CI: 0.36–0.64, HR: 0.78, 95% CI 0.50–1.20

J. S. Lee et al. (2009) [58]FIRST SIGNAL1st line, clinically selected309Gefitinib versus Cisplatin +
Gemcitabine
53.5 versus 45.3 ( )6.1 versus 6.6 HR: 0.813, 95% CI: 0.641–1.031, 21.3 versus 23.3 HR: 1.003, 95% CI: 0.749–1.343,
Subgroup of EGFR mutated4284.6 versus 37.5 ( )8.5 versus 6.7 HR: 0.613, 95% CI: 0.308–1.221, 30.6 versus 26.5 HR: 0.823, 95% CI: 0.352–1.922,

Mitsudomi et al. (2010) [59]WJTOG 34051st line, EGFR mutated172Gefitinib versus Cisplatin +
Docetaxel
62.1 versus 32.2 ( )9.2 versus 6.3 HR 0.489, 95% CI: 0.336–0.710, 30.9 versus nr HR: 1.638, 95% CI 0.749–3.582,

Maemondo et al. (2010) [60]NEJ0021st line, EGFR mutated230Gefitinib versus Carboplatin +
Paclitaxel
73.7 versus 30.7 ( )10.8 versus 5.4 HR 0.30, 95% CI: 0.22–0.41, 30.5 versus 23.6

RR: response rate; PFS: progression-free survival; OS: overall survival; nr: not reached.