Table 1.

Phase II and phase III studies of selected antigen-specific immunotherapeutic approaches in nonsmall-cell lung cancer

Investigational agent	Phase of study	N	Patients	Primary end point	Primary end point outcome		Significance of differences between treatment group and control group
					Treatment group	Control group
Tecemotide	Randomized phase II (Butts and Maksymiuk et al. [12])	171	IIIB or IV NSCLC SD or OR after first-line chemotherapy or chemoradiation	OS	17.2 m	13 m	NS
	Randomized, double-blind placebo-controlled phase III (Butts and Socinski et al. [14])	1513	IIIA (T3, N2 only), IIIB and IV SD or OR after first-line chemotherapy or chemoradiation	OS	25.6 m	22.3 m	NS
Belagenpumatucel-L	Randomized, dose-variable phase II (Nemunaitis et al. [7])	75	II, IIIA, IIIB and IV; low tumor burden Completed conventional therapy	OS	Dose-related improvements in survival in three treatment armsa	NA	No control arm
	Randomized, double-blind placebo-controlled phase III (Giaccone et al. [8])	532	IIIA (T3, N2 only), IIIB and IV SD or OR after primary platinum-based chemoradiotherapy	OS	20.3	17.8	NS
Melanoma-associated antigen-A3 vaccine	Randomized phase II (Vansteenkiste [15])	182	Completely resected IB/II MAGE-A3-expressing tumor	DFI	HR 0.74 (95% CI 0.44–1.20) P = 0.107b	NA	NS
	Randomized, double-blind placebo-controlled phase III (release 2014)	2312	Completely resected IB, II, or IIIA MAGE-A3-expressing tumor	DFS	Not available	Not available	NS

^aThree doses (1.25, 2.5 or 5.0 × 107 cells/injection) of belagenpumatucel-L were studied in three cohorts of 25, 26 and 24 patients each.

^bHR in favor of the MAGE-A3 group.