At a glance
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Combined Phase I/II Clinical Study of EMD531444(L-BLP25 or BLP25 Liposome Vaccine) in Subjects With Stage III Unresectable Non-small Cell Lung Cancer Following Primary Chemoradiotherapy
In Brief
A Phase 2 clinical trial evaluating Tecemotide (L-BLP25), Single low dose cyclophosphamide, and 2 other interventions for Non-small Cell Lung Cancer. Completed, enrolled 178 participants across 1 site.
Detailed Summary
This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.
Study Details
Timeline
Interventions
After receiving a single low-dose cyclophosphamide, participants will receive weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram \[mcg\]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) will be administered every 6 weeks until progressive disease (PD).
A single intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg/m\^2) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment.
After receiving single dose of saline, participants will receive weekly subcutaneous vaccinations with placebo that matches with tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo will be administered every 6 weeks until PD.
A single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) will be administered intravenously, 3 days prior to the start of placebo.