Table 4.

Phase III clinical studies with lonidamine in lung cancer.

Patients accrued	Treatment	Main findings	Observations	References
184	LND versus mit + vds versus LND + mit + vds	ORR (%) 3.4% versus 22.4% versus 25.9% p < 0.01	1-year OS rate mit + vds 20% mit + vds + LND 32%	[55]
158	cis + epi + vds versus cis + epi + vds + LDN	ORR (%) 24 versus 43 p = 0.02	Median TTP  5 versus 8 m. p = 0.0007  Median OS  7.6 versus 11 m. p = 0.0013	[56]
151	MACC versus MACC + LND	ORR (%) 7 versus 13	Median PFS 17 versus 20 weeks p = NS  Median OS 27 versus 30 weeks p = NS	[57]
126	LND versus vds versus LND + vds versus BSC	ORR (%) LND 3.3 LDN + vds 6	Elderly patients Median OS all pts 24.2 weeks No differences among regimens	[58]
310	LND + RT versus pla + RT	More local control in LND + RT arm (p = NS)	Median PFS 7.6 versus 6.5 months, p = 0.75  Median OS 13 versus 10.8 months p = 0.41	[59]

mit: mitomycin-C; vds: vindesine; MACC; methotrexate-doxorubicin-cyclophosphamide-CCNU; BSC: best supportive care; ORR: overall response rate; PFS: progression-free survival; OS: overall survival; TTP: time to progression.