Table 1.
select clinical trials in lung cancer involving anti-EGFR therapies
| Trial | Type | Drugs | enrollment criteria | rr (%) (EGFR TKI versus other) | Median time to treatment failure (months) (EGFR TKI versus other therapy) | refs |
|---|---|---|---|---|---|---|
| Gefitinib | ||||||
| IDEAL-1, IDEAL-2 | Phase II | Gefitinib (250 mg versus 500 mg) | Unselected previously treated NSCLC | 18.4–19.0 (IDEAL-1) and 9–12 (IDEAL-2) | 2.7–2.8 (IDEAL-1) and 1.5–1.7 (IDEAL-2) | 11, 12 |
| ISEL | Phase III | Gefitinib versus placebo | Unselected previously treated NSCLC | 8.0 versus 1.3 | 3.0 versus 2.6 | 19 |
| INTACT-1, INTACT-2 | Phase III | Chemotherapy ± gefitinib (250 mg versus 500 mg) | Unselected chemotherapy-naive NSCLC | 50.3–51.2 versus 47.2 (INTACT-1) and 30 versus 28.7 (INTACT-2) | 5.5–5.8 versus 6.0 (INTACT-1) and 4.6–5.3 versus 5.0 (INTACT-2) | 168, 169 |
| INTEREST | Phase III | Gefitinib versus docetaxel | Unselected previously treated NSCLC | 9.1 versus 7.6 | 2.2 versus 2.2 | 157 |
| IPASS | Phase III | Gefitinib versus chemotherapy | East Asian never or light smokers with chemotherapy-naive lung adenocarcinoma | 43.0 versus 32.2* 71.2 versus 47.3‡ |
5.7 versus 5.8* 9.5 versus 6.3‡ |
20 |
| WJTOG3405 | Phase III | Gefitinib versus chemotherapy | Japanese EGFR-mutant chemotherapy-naive NSCLC | 62.1 versus 32.2 | 9.2 versus 6.3 | 21 |
| NEJ002 | Phase III | Gefitinib versus chemotherapy | Japanese EGFR-mutant chemotherapy-naive NSCLC | 73.7 versus 30.7 | 10.8 versus 5.4 | 24 |
| Erlotinib | ||||||
| NA | Phase II | Erlotinib | NSCLC with BAC features | 22 | 4 | 13 |
| BR.21 | Phase III | Erlotinib versus placebo | Unselected previously treated NSCLC | 8.9 versus <1 | 2.2 versus 1.8 | 18 |
| TALENT | Phase III | Chemotherapy ± erlotinib | Unselected chemotherapy-naive NSCLC | 31.5 versus 29.9 | 6.4 versus 6.0 | 158 |
| TRIBUTE | Phase III | Chemotherapy ± erlotinib | Unselected chemotherapy-naive NSCLC | 21.5 versus 19.3 | 5.1 versus 4.9 | 170 |
| SLCG | Single arm | Erlotinib | Spanish EGFR-mutant NSCLC | 70.6 | 14 | 23 |
| Cetuximab | ||||||
| FLEX | Phase III | Chemotherapy ± cetuximab | EGFR IHC-positive chemotherapy-naive NSCLC | 36 versus 29 | 4.8 versus 4.8 | 171 |
| BMS099 | Phase III | Chemotherapy ± cetuximab | Unselected chemotherapy-naive NSCLC | 25.7 versus 17.2 | 4.4 versus 4.2 | 49 |
BAC, bronchioloalveolar carcinoma; EGFR, epidermal growth factor receptor; IHC, immunohistochemistry; NA, not applicable; NSCLC, non-small-cell lung cancer; RR, response rate; TKI, tyrosine kinase inhibitor.
*
Statistic for the entire population.
‡
Statistic for the patients only with EGFR-mutant tumours.