. 2013 Apr;20(2):e150–e160. doi: 10.3747/co.20.1226

TABLE II.

Selected trials beyond first-line treatment

Reference (study name)	Primary endpoint	Pts (n)	Arms	Group	Progression-free survival (pfs)				Overall survival (os)				Post-protocol treatment
Reference (study name)	Primary endpoint	Pts (n)	Arms	Group	Months	hr	95% cl	p Value	Months	hr	95% cl	p Value	Post-protocol treatment
Fossella et al., 2000³⁹ (tax 320)	os	373	Docetaxel	itt	26 Weeks: 17%			0.031	1 Year: 32%			0.025	No crossover planned
Fossella et al., 2000³⁹ (tax 320)	os	373	Vinorelbine or ifosfamide		26 Weeks: 8%				1 Year: 19%				No crossover planned
Shepherd et al., 2000³⁸ (tax 317)	os	204	Docetaxel	itt					7.0	0.48		0.047	No crossover planned
Shepherd et al., 2000³⁸ (tax 317)	os	204	Best supportive care					4.6					No crossover planned
Hanna et al., 2004⁴⁰ (jmei)	os	571	Pemetrexed	itt	2.9	0.97	0.82,1.16	ns	8.3	0.99	0.82, 1.2	0.226	No crossover planned
			Docetaxel	2.9					7.9
				Subgroup: non-squamous		0.82	0.66, 1.02	0.76		0.78	0.61, 1.00	0.047
Shepherd et al. 2005 (br.21)¹⁸	os	731	Erlotinib	itt	2.2	0.61	0.51,0.74	<0.001	6.7	0.7	0.58, 0.85	<0.001	No crossover planned
Shepherd et al. 2005 (br.21)¹⁸	os	731	Placebo		1.8				4.7				No crossover planned
Thatcher et al., 2005⁴¹ (isel)	os	1692	Gefitinib	itt					5.6	0.89	0.77,1.02	0.087	No crossover planned
		1692	Placebo						5.1
		767		Subgroup: adenocarcinoma					6.3	0.84	0.68, 1.03	0.089
		767		Subgroup: adenocarcinoma					5.4
Miller et al., 2011⁴² (lux-Lung1)	os	585	Afatinib	itt	3.3	0.38	0.31, 0.48	<0.0001	10.8	1.08	0.86, 1.35	0.74	No crossover planned
Miller et al., 2011⁴² (lux-Lung1)	os	585	Placebo		1.1				12.0				No crossover planned
Lee et al., 2012⁴³ (zephyr)	os	924	Vandetanib	itt	1.9	0.63	0.54, 0.74	<0.001	8.5	0.95	0.81,1.11	0.527	No crossover planned
Lee et al., 2012⁴³ (zephyr)	os	924	Placebo		1.8				7.8				No crossover planned

Pts = patients; hr = hazard ratio; cl = confidence limits; itt = intention-to-treat; ns = nonsignificant.