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

NCT00960115 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2015-10-21

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Merck Serono Co., Ltd., Japan

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2014-05-31
Completion
2015-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960115 on ClinicalTrials.gov