A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Anemia

Intervention / Treatment
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* Drug: Darbepoetin alfa
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mircera 6.3 micrograms/kg<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 6.3 micrograms/kg every 3 weeks<br>|
| Experimental: Mircera 9 micrograms/kg<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 9 micrograms/kg every 3 weeks<br>|
| Experimental: Mircera 12 micrograms/kg<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* 12 micrograms/kg every 3 weeks<br>|
| Active Comparator: Darbepoetin alfa<br> | Drug: Darbepoetin alfa<br>* According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Hb change from baseline |  | Weeks 5-13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |