drugset / Trial / NCT04325698
A BRIDGING STUDY OF PF-06439535 (CN) PLUS PACLITAXEL-CARBOPLATIN VERSUS BEVACIZUMAB PLUS PACLITAXEL-CARBOPLATIN IN NSCLC
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The current study will compare the efficacy, safety, pharmacokinetics and immunogenicity of PF-06439535 (CN) in combination with paclitaxel and carboplatin versus bevacizumab sourced from the European Union (bevacizumab-EU) with paclitaxel and carboplatin in Chinese participants with advanced non-squamous NSCLC in the first-line treatment setting.
Timeline
- Start
- 2020-06-11
- Primary completion
- 2021-05-10
- Completion
- 2021-05-10
Outcome
Outcome not reported
Stopped: “The study was terminated as part of the decision by Pfizer to halt its biosimilars programs in China.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab-EU | Unknown | 15 mg/kg | Intravenous |
| Subject | PF-06439535 (CN) | Unknown | 15 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |