Clinical trial · Interventional
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darbepoetin alfa | Drug | — | UNRESOLVED |
| methoxy polyethylene glycol-epoetin beta [Mircera] | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Mircera 6.3 micrograms/kg
- interventionNames
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- type
- EXPERIMENTAL
- label
- Mircera 9 micrograms/kg
- interventionNames
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- type
- EXPERIMENTAL
- label
- Mircera 12 micrograms/kg
- interventionNames
- Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available