Table 3.

Clinical trials of cetuximab and chemotherapy combination versus chemotherapy alone.

Study	Trial	Phase	Trial size (n)	Chemotherapy	Primary endpoint	Median PFS (month)	HR (95% CI)	Median OS (month)	HR (95% CI)
Butts et al. [2007]	–	II	65	Cisplatin or carboplatin/gemcitabine	RR	5.09 versus 4.21	–	12.0 versus 9.3	–
Rosell et al. [2008]	–	II	86	Cisplatin/ vinorelbine	RR, safety, PK	5.0 versus 4.6	–	8.3 versus 7.3	–
Pirker et al. [2009]	FLEX	III	1125	Cisplatin/ vinorelbine	OS	PFS reported as NS	–	11.3 versus 10.1	0.87 (0.762 − 0.996); p = 0.044
Lynch et al. [2010]	BMS099	III	676	Carboplatin/ taxane (paclitaxel or docetaxel)	PFS	4.40 versus 4.24	0.9 (0.76 − 1.07); p = 0.236 (NS)	9.7 versus 8.4	0.89 (0.75 − 1.05); p = 0.17 (NS)

BMS099, Bristol-Myers Squibb 099; CI, confidence interval; FLEX, First-Line Erbitux in Lung Cancer; HR, hazard ratio; NS, not significant; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; RR, response rate.