Table 1 Selected phase II and III clinical trials of anti-EGFR drugs in non-small cell lung cancer
From: Recent advances of novel targeted therapy in non-small cell lung cancer
Study | Disease Setting | Treatment (dose) (No. of patients) | ORR (CR+PR) (%) | mTTP (months) | mPFS (months) | mOS (months) |
|---|---|---|---|---|---|---|
Single arm phase II (Perez-Soler et al.) | Metastatic platinum refractory disease | erlotinib monotherapy (150 mg/day) (57) | 12.3 | N.R. | N.R. | 8.4 |
Randomized phase II, IDEAL 1 trial (Fukuoka et al.) | Metastatic platinum refractory disease (second and third line of treatment) | gefitinib monotherapy (250 mg/day) (103) gefitinib monotherapy (500 mg/day) (106) | 18.4 19.0 (p = NS) | N.R. | 2.7 2.8 (p = NS) | 7.6 8.0 (p = NS) |
Randomized phase II, IDEAL 2 trial (Kris et al.) | Metastatic platinum and Docetaxel refractory disease (third line of treatment) | gefitinib monotherapy (250 mg/day) (102) gefitinib monotherapy (500 mg/day) (114) | 12 9 (p = NS) | N.R. | N.R. | 7.0 6.0 (p = NS) |
Randomized phase III, BR.21 trial (Sheperd et al.) | Metastatic platinum refractory disease (second and third line of treatment) | erlotinib monotherapy (150 mg/day) (448) Placebo (243) | 9 <1 (p < 0.0001) | N.R. | 2.2 1.8 HR 0.70 (95% CI, 0.58–0.87) (p < 0.001) | 6.7 4.7 HR 0.61 (95% CI, 0.51–0.74) (p = 0.001) |
Randomized phase III, ISEL trial (Thatcher et al.) | Metastatic platinum refractory disease (second and third line of treatment) | gefitinib monotherapy (250 mg/day) (1129) Placebo (563) | 8 1 (p < 0.0001) | N.R. | N.R. | 5.6 5.1 HR 0.89 (95% CI, 0.77–1.02) (p = NS) |
Randomized phase III, BETA tiial (Hainsworth et al.) | Metastatic, second line therapy | Erlotinib monotherapy (150 mg/day) (313) erlotinib (150 mg/day) + bevacizumab (15 mg/kg) (313) | 6.2 6.2 (p = 0.006) | N.R. | 1.7 3.4 HR 0.62 (95% CI 0.52–0.75) (p < 0.0001) | 9.2 9.3 HR 0.97 (95% CI, 0.80–1.18) (p = NS) |
Randomized phase III, INTEREST trial (Kim et al.) | Metastatic platinum refractory disease (second line of treatment) | gefitinib monotherapy (250 mg/day) (733) Docetaxel (733) | 9.1 7.6 (p = NS) | N.R. | 2.2 2.7 HR 1.04 (95% CI, 0.93–1.18) (p = NS) | 7.6 8.0 HR 1.02 (95% CI, 0.90–1.15) (p = NS) |
Randomized phase III, TRIBUTE trial (Herbst et al.) | Metastatic, first line treatment | carboplatin + paclitaxel + erlotinib (150 mg/day) (539) carboplatin + paclitaxel + placebo (540) | 21.5 19.3 (p = NS) | 5.1 4.9 (p = NS) | N.R. | 10.6 10.5 (p = NS) |
Randomized phase III, TALENT trial (Gatzmeier et al.) | Metastatic, first line treatment | cisplatin + gemcitabine + erlotinib (150 mg/day) (533) cisplatin + gemcitabine + placebo (536) | 31.5 29.9 (p = NS) | 5.1 4.9 (p = NS) | N.R. | 10.0 10.3 (p = NS) |
Randomized phase III, INTACT-1 trial (Giaccone et al.) | Metastatic, first line treatment | cisplatin + gemcitabine + gefitinib (250 mg/day) (365) cisplatin + gemcitabine + gefitinib (500 mg/day) (365) cisplatin + gemcitabine + placebo (363) | 51.2 50.3 47.2 (p = NS) | N.R. | 5.8 5.5 6.0 (p = NS) | 9.9 9.9 10.9 (p = NS) |
Randomized phase III, INTACT-2 trial (Herbst et al.) | Metastatic, first line treatment | carboplatin + paclitaxel + gefitinib (250 mg/day) (345) cisplatin + paclitaxel + gefitinib (500 mg/day) (347) cisplatin + paclitaxel + placebo (345) | 30.4 30 28.7 (p = NS) | N.R. | 5.3 4.6 5.0 (p = NS) | 9.8 8.7 9.9 (p = NS) |