| Trial | control | p<0.05 | harm | NS |
|---|
| OPTIMAL | erlotinib vs Platinum-based CT | PFS 0.16 [0.10; 0.26] median 13.1 mo vs. 4.6 mo | | |
| EUTRAC | erlotinib vs Platinum-based CT | PFS 0.37 [0.25; 0.54] | | |
| TITAN | erlotinib vs Platinum-based CT | | | OS 0.96 [0.78; 1.19] |
| TRIBUTE (Herbst) | erlotinib + Platinum-based CT vs Platinum-based CT | | | OS 1.00 [0.86; 1.16] ORR 1.11 [0.73; 1.68] |
| Gatzemeier | erlotinib + Platinum-based CT vs Platinum-based CT | | | PFS 0.98 [0.86; 1.11] ORR 1.05 [0.89; 1.24] |
| Mok | erlotinib + Platinum-based CT vs Platinum-based CT | PFS 0.71 [0.62; 0.82] | | OS 1.09 [0.70; 1.69] ORR 1.46 [0.89; 2.39] |
| SATURN (Cappuzzo) | erlotinib + Platinum-based CT vs Platinum-based CT | OS 0.81 [0.70; 0.94] | | |
| Boutsikou | erlotinib + Platinum-based CT vs Platinum-based CT | | | OS 0.81 [0.39; 1.69] |
| Lee | erlotinib + Platinum-based CT vs Platinum-based CT | PFS 0.58 [0.39; 0.86] ORR 1.56 [1.02; 2.38] | | OS 0.75 [0.49; 1.14] |
| Stinchcombe | erlotinib + Platinum-based CT vs Platinum-based CT | | | OS 1.20 [0.76; 1.90] PFS 0.87 [0.60; 1.27] ORR 3.16 [0.94; 10.62] |
| FASTACT-2 (Wu) | erlotinib + Platinum-based CT vs Platinum-based CT | OS 0.79 [0.64; 0.98] PFS 0.57 [0.47; 0.69] ORR 2.36 [1.72; 3.23] | | |
| Trial | Treatments | Patients | Method |
|---|
| OPTIMAL | oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects (n=83) vs. up to four cycles of gemcitabine plus carboplatin (n=82) | Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) | open-label Sample size: 83/82 Primary endpoint: progression-free survival FU duration: |
| EUTRAC | oral erlotinib 150 mg per day (n=-9) vs. 3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m(2) on day 1 plus docetaxel (75 mg/m(2) on day 1) or gemcitabine (1250 mg/m(2) on days 1 and 8). (n=-9) | adults (> 18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ¡Ý 6 months before study entry was allowed) | open-label Sample size: -9/-9 Primary endpoint: FU duration: |
| TITAN | erlotinib 150 mg/day (n=-9) vs. chemotherapy (standard docetaxel or pemetrexed regimens, at the treating investigators' discretion) until unacceptable toxicity, disease progression, or death (n=-9) | second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis | open-label Sample size: -9/-9 Primary endpoint: FU duration: |
| TRIBUTE (Herbst) | erlotinib 150 mg/d combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib (n=526) vs. placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib (n=533) | patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC | Sample size: 526/533 Primary endpoint: overall survival FU duration: |
| Gatzemeier | Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles (n=579) vs. Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles (n=580) | first-line treatment for advanced non-small-cell lung cancer | Sample size: 579/580 Primary endpoint: FU duration: |
| Mok | Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and either Cis75 mg/m2 D1 or Car AUC = 5, D1) (n=57) vs. Gem 1,250 mg/m2 D1,8 and either (n=57) | first-line treatment for advanced non-small-cell lung cancer | Sample size: 57/57 Primary endpoint: FU duration: |
| SATURN (Cappuzzo) | Erl 150 mg/day plus select one of seven standard chemotherapy regimens (n=438) vs. Cis75 mg/m2 D1 or Car AUC = 5, D1 (n=451) | maintenance treatment in advanced non-small-cell lung cancer | Sample size: 438/451 Primary endpoint: FU duration: |
| Boutsikou | Erl 150 mg/day plus (Doc 100 mg/ m 2 and Car AUC = 5.5 q28d*4) (n=52) vs. Doc 100 mg/m2 and Car AUC = 5.5 q28d*4 (n=61) | first-line treatment of patients with NSCLC | Sample size: 52/61 Primary endpoint: FU duration: |
| Lee | Erl 150 mg/day plus Pem 500 mg/ m 2 D1 q21d (n=78) vs. Pem 500 mg/m2 D1 q21d (n=80) | second-line treatment for never-smokers with non-squamous non-small cell lung cancer | Sample size: 78/80 Primary endpoint: progression-free survival FU duration: |
| Stinchcombe | Erl 150 mg/day plus Gem 1,200 mg/m2 D1,8 q21d (n=51) vs. Gem 1,200 mg/m2 D1,8 q21d (n=44) | elderly patients (age ¡Ý70 years) with stage IIIB or IV non-small cell lung cancer | Sample size: 51/44 Primary endpoint: progression-free survival FU duration: |
| FASTACT-2 (Wu) | Erl 150 mg/day plus Gem 1,250 mg/m2 D1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1 (n=226) vs. Gem 1,250 mg/m2, d1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1 (n=255) | patients with untreated stage IIIB/IV non-small-cell lung cancer | Sample size: 226/255 Primary endpoint: FU duration: |
