NCT00960115

Study of Tecemotide (L-BLP25) in Participants With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Phase I part is designed to evaluate the safety of EMD531444 930 microgram (mcg) dose to be used in phase II. Phase II part is designed to be conducted as randomized, double blind, placebo controlled study to compare overall survival time in all randomized subjects.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tecemotide (L-BLP25)	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).
DRUG	Single low dose cyclophosphamide	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.
BIOLOGICAL	Placebo	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.
OTHER	Saline	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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2014-05-01
• Completion: 2015-06-01
• First posted: 2009-08-17
• Last updated: 2015-10-21
• Results posted: 2015-10-21

Locations

1 site across 1 country: Germany