drugset / Trial / NCT01218516

A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung

NCT01218516 ↗

Phase 2 Completed 130 enrolled Morphotek
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

EvaluationDrugModalityDoseRoute
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

Indications