Table 1.

Completed Clinical Trials of Tecemotide

Study Identifier Indication	Description	Patients Enrolled	Reference
EMR 63325–002 Stage IIIB or IV NSCLC	Phase l randomized open-label safety and dose comparison study.	17	24
EMR 63325–003 Stage IIIB or IV NSCLC	Phase II open-label safety and immunogenicity study.	8	70
EMR 63325–004 Stage IIIB or IV NSCLC	Phase II open-label, dose-escalation study to determine safety and immunogenicity of tecemotide in combination with liposomal IL-2.	18	70
NCT00157209 EMR 63325–005 Stage IIIB or IV NSCLC	Phase IIB open-label, randomized study to test safety and efficacy of tecemtotide plus BSC compared to BSC alone.	171	22, 23
NCT00157196 EMR 63325–006 Unresectable stage III NSCLC	Phase II open-label study to assess safety of tecemotide made with a new formulation of the immunoadjuvant MPL®.	22	71
NCT00409188 EMR 63325–001 (START) Unresectable stage III NSCLC	A multicenter randomized double-blind placebo-controlled Phase III trial of tecemotide versus placebo in patients with unresectable stage III NSCLC.	1513	12
EMR 63325–007 Prostate cancer	Phase II open-label trial to test safety and efficacy of tecemotide in patients with rising PSA values following radical prostatectomy.	16	72
NCT01094548 EMR 63325–008 Multiple myeloma	Phase II open-label, dose-escalation study to determine safety and efficacy of L-BLP25 in multiple myeloma, either chemotherapy naïve, slowly progressive and asymptomatic or with stage II/III in stable response/plateau following anti-tumor therapy.	34	In preparation