Table 3. Phase III trials of combination with platinum-based CT and EGFR TKI in 1st-line.
Trial | Study population | Treatment | No. of pts | Median OS | RR (%) | P |
---|---|---|---|---|---|---|
INTACT 1 | Treatment naive | Cis/gem + gefitinib 500 | 1,093 | 9.9 months | 50 | |
Cis/gem + gefitinib 250 | 9.9 months | 51 | NS | |||
Cis/gem + placebo | 10.9 months | 47 | ||||
INTACT 2 | Treatment naive | Carbo/pacli + gefitinib 500 | 1,037 | 8.7 months | 30 | |
Carbo/pacli + gefitinib 250 | 9.8 months | 30 | NS | |||
Carbo/pacli + placebo | 9.9 months | 29 | ||||
TRIBUTE | Treatment naive | Carbo/pacli + erlotinib 150 | 1,079 | 10.6 months | 22 | NS |
Carbo/pacli + placebo | 10.5 months | 19 | ||||
TALENT | Treatment naive | Cis/gem + erlotinib 150 | 1,172 | 43 weeks | 32 | NS |
Cis/gem + placebo | 44.1 weeks | 30 |
NS, not significant; EGFR, epidermal growth factor receptor; TKI, tyrosine-kinase inhibitor; RR, response rates.