drugset / Trial / NCT01218516
A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.
Timeline
- Start
- 2011-06-27
- Primary completion
- 2012-12-15
- Completion
- 2013-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Farletuzumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |