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
November, 2010
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov identifier: NCT00111839
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Active Control, 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