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Table 1 Phase III Studies Investigating the efficacy of EGFR inhibition alone or as part of the 1 st line treatment for stage IIIB-IV NSCLC

From: EGFR inhibition in non-small cell lung cancer: current evidence and future directions

Study Stage Study Arms # Pts ORR Median PFS Median OS
TKI
INTACT 1 [15] IIIB-IV Cisplatin + Gemcitabine (CG) vs. CG + Gefitinib 250 mg/d vs. CG + Gefitinib 500 mg/d 363 vs. 365 vs. 365 47.20% vs. 51.20% vs. 50.30%, p = ns 6.0 mo vs. 5.8 mo vs. 5.5 mo, p = 0.7633 10.9 mo vs. 9.9 mo vs. 9.9 mo, p = 0.4560
INTACT 2 [16] III-IV Carboplatin + Paclitaxel (CP) vs. CP + Gefitinib 250 mg/d vs. CP + Gefitinib 500 mg/d 345 vs. 345 vs. 347 28.70% vs. 30.40% vs. 30.00%, p = ns 5.0 mo vs. 5.3 mo vs. 4.6 mo, p = 0.0562 9.9 mo vs. 9.8 mo vs. 8.7 mo, p = 0.6385
TRIBUTE [17] IIIB-IV Carboplatin + Paclitaxel (CP) vs. CP + Erlotinib; followed by Erlotinib maintenance 540 vs. 539 19.30% vs. 21.50%, p = 0.36 4.9 mo vs. 5.1 mo, p = 0.36 10.5 mo vs. 10.6 mo, p = 0.95
IPASS [18] Non smokers or former light smokers with adenocarcinoma IIIB-IV Carboplatin + Paclitaxel vs. Gefitinib 608 vs. 609 32.20% vs. 43.00%, p <0.001 6.7% vs. 24.9% at 1 year, p <0.001 17.3 mo vs. 18.6 mo
WJTOG3405 [19] Sensitive EGFR mutation + only IIIB-IV, postoperative recurrent Gefitinib vs. Cisplatin + Docetaxel 86 vs. 86 62.10% vs. 32.20%, p <0.0001 9.2 mo vs. 6.3 mo, p <0.0001 30.9 mo vs. not reached, p = 0.211
OPTIMAL [20] Sensitive EGFR mutation + only IIIB-IV Erlotinib vs. Carboplatin + Gemcitabine 82 vs. 72 83% vs. 36%, p <0.0001 13.1 mo vs. 4.6 mo, p <0.0001  
NEJ002 [21] Sensitive EGFR mutation + only IIIB-IV, postoperative recurrent Gefitinib vs. Carboplatin/ Paclitaxel 114 vs. 114 73.7% vs. 30.7%, p <0.001 10.8 mo vs. 5.4 mo, p <0.001 27.7 mo vs. 26.6 mo, p = 0.483
EURTAC [22] Sensitive EGFR mutation + only IIIB-IV Erlotinib v s. Platinum based chemotherapy 86 vs. 87 63% vs. 18%, p <0.001 9.7 mo vs. 5.2 mo, p <0.0001 19.3 mo vs. 19.5 mo, p = 0.87
TORCH [23] IIIB-IV Erlotinib vs. Cisplatin/ Gemcitabine as 1st line treatment, and the opposite as 2nd line therapy 373 vs. 371 20.3% vs. 32.6%; 2nd line Erlotinib vs. 2nd line chemo: 4.7% vs. 10.5%; p <0.001 6.4 mo vs. 8.9 mo 8.7 mo vs. 11.6 mo
Cetuximab
FLEX [33] IIIB-IV Cisplatin + Vinorelbine (CV) vs. CV + Cetuximab 568 vs. 557 29% vs. 35%, p = 0.010 4.8 mo vs. 4.8 mo, p = 0.39 10.1 mo vs. 11.3 mo, p = 0.044
BMS099 [34] IIIB-IV Carboplatin + Taxane (CT) vs. CT + Cetuximab 338 vs. 338 17.20% vs. 25.70%, p = 0.007 4.24 mo vs. 4.40 mo, p = 0.2358 8.38 mo vs. 9.69 mo, p = 0.169
  1. Abbreviations: ORR: objective response rate; PFS: progression free survival; OS: overall survival.