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Brief Title: A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
Official Title: A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy
Study ID: NCT00327535
Brief Summary: This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \<3 months and the target sample size is 100-500 individuals.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, East Bentleigh, , Australia
, Kurralta Park, , Australia
, Milton, , Australia
, Linz, , Austria
, Salzburg, , Austria
, Wien, , Austria
, Wien, , Austria
, Wien, , Austria
, Aalst, , Belgium
, Edegem, , Belgium
, Liege, , Belgium
, Toronto, Ontario, Canada
, Toronto, Ontario, Canada
, Brno, , Czech Republic
, Hradec Kralove, , Czech Republic
, Ostrava, , Czech Republic
, Praha, , Czech Republic
, Tallin, , Estonia
, Tartu, , Estonia
, Helsinki, , Finland
, Bobigny, , France
, Caen, , France
, Dijon, , France
, Lyon, , France
, Paris, , France
, Pessac, , France
, Pierre Benite, , France
, Saint Pierre, , France
, Gauting, , Germany
, Hamburg, , Germany
, Hamburg, , Germany
, Heidelberg, , Germany
, Karlsruhe, , Germany
, Trier, , Germany
, Athens, , Greece
, Heraklion, , Greece
, Larissa, , Greece
, Thessaloniki, , Greece
, Thessaloniki, , Greece
, Hong Kong, , Hong Kong
, Hong Kong, , Hong Kong
, Budapest, , Hungary
, Deszk, , Hungary
, Mátraháza, , Hungary
, Nyiregyhaza, , Hungary
, Szekesfehervar, , Hungary
, Genova, , Italy
, Legnago, , Italy
, Novara, , Italy
, Pavia, , Italy
, Ravenna, , Italy
, San Giovanni Rotondo, , Italy
, Sassari, , Italy
, Bydgoszcz, , Poland
, Elblag, , Poland
, Otwock, , Poland
, Poznan, , Poland
, Radom, , Poland
, Wloclawek, , Poland
, Wroclaw, , Poland
, Barcelona, , Spain
, Barcelona, , Spain
, Girona, , Spain
, La Laguna, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Zaragoza, , Spain
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR