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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
153
According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)
6.3 micrograms/kg every 3 weeks
9 micrograms/kg every 3 weeks
Average Hb change from baseline
Time frame: Weeks 5-13
Target Hb therapeutic range, average Hb values, hematopoietic response.
Time frame: Days 2-85
Red blood cell (RBC) transfusions
Time frame: Weeks 5-13
Adverse events (AEs), laboratory parameters, premature withdrawals
Time frame: Throughout study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
12 micrograms/kg every 3 weeks
Unnamed facility
East Bentleigh, Australia
Unnamed facility
Kurralta Park, Australia
Unnamed facility
Milton, Australia
Unnamed facility
Linz, Austria
Unnamed facility
Salzburg, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Vienna, Austria
Unnamed facility
Aalst, Belgium
Unnamed facility
Edegem, Belgium
...and 58 more locations