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Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer

Study:

Randomized, Phase II,Open-Label Controlled Study of Two Different Doses and Schedules of EMD 72000 (Matuzumab) in Combination With Pemetrexed, or Pemetrexed Alone, as Second-Line Treatment for Stage IIIB/IV Non-Small Cell Lung Cancer and Progressive Disease on or After First-Line Treatment With a Platinum in Combination With Taxanes, Gemcitabine and Vinorelbine

Rationale:

n/a

Purpose:

This study is planned to answer questions about how the drug, matuzumab (EMD 72000), works and is part of an effort aimed to develop better treatment for advanced lung cancer by combining matuzumab, a monoclonal antibody, with a chemotherapy treatment, called pemetrexed. Pemetrexed is commercially available and has been approved for treatment of locally advanced or metastatic non-small cell lung cancer that could not be successfully treated with other chemotherapy. The study aims to examine how non-small cell lung cancer (NSCLC) responds to matuzumab in combination with pemetrexed, as compared with giving pemetrexed alone. The study also aims to examine how safe and effective matuzumab is and for how long it stays in the body (pharmacokinetics). Matuzumab is an experimental treatment which is currently only available for research studies.

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Lung Cancer
Non Small Cell Lung Carcinoma
Drug: Pemetrexed
Drug: Matuzumab + Pemetrexed
Drug: Matuzumab + Pemetrexed
Phase 2

Verified by EMD Serono October, 2013

Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov identifier: NCT00111839

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

The Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States

Joan Schiller, MD., Principal Investigator
Mark Socinski, MD., Principal Investigator

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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