A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- >=18 years of age;
- stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;
- myelosuppressive chemotherapy scheduled for at least 9 weeks;
- anemia at screening visit.
Exclusion criteria
- transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;
- iron deficiency anemia, or anemia caused by gastrointestinal bleeding;
- prior treatment with Mircera.
Trial design
Primary purpose
Allocation
Interventional model
Masking
153 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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