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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 153
- Primary Endpoint
- Average Hb change from baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Mircera 6.3 micrograms/kg
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Mircera 9 micrograms/kg
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Mircera 12 micrograms/kg
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera] (Drug)
Darbepoetin alfa
Intervention: Darbepoetin alfa (Drug)
Outcomes
Primary Outcomes
Average Hb change from baseline
Time Frame: Weeks 5-13
Secondary Outcomes
- Target Hb therapeutic range, average Hb values, hematopoietic response.(Days 2-85)
- Red blood cell (RBC) transfusions(Weeks 5-13)
- Adverse events (AEs), laboratory parameters, premature withdrawals(Throughout study)