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Study of EMD531444 in Subjects With Stage III Unresectable Non-small Cell Lung Cancer (NSCLC) Following Primary Chemoradiotherapy

2014-07-24 14:11:49 | BioPortfolio

Summary

Darmstadt, Germany, June 17 2010 - Merck Serono, a division of Merck KGaA, and its U.S. affiliate, EMD Serono, Inc. today announced that they are resuming their Stimuvax® (BLP25 liposome vaccine)* clinical program in patients with non-small cell lung cancer (NSCLC) which includes the Phase III studies, START and INSPIRE. The treatment and enrollment in these studies will restart after approval by the local regulatory authorities and ethics committees.

More information can be accessed here: http://www.merck.de/en/media/extNewsDetail.html?newsId=0BDEF079C946D24FC1257744005B84C0&newsType=1

Description

A study to evaluate the safety of EMD531444 and its effects on survival time in patients with non-small cell lung cancer.

Phase I part is designed to evaluate the safety of EMD531444 1000mcg 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Non-small Cell Lung Cancer

Intervention

cyclophosphamide + EMD531444 + BSC, Saline + Placebo + BSC

Location

Central Contact
Darmstadt
Germany

Status

Active, not recruiting

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:11:49-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

A form of highly malignant lung cancer that is composed of small ovoid cells (SMALL CELL CARCINOMA).

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