NCT01218516

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

A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in Combination With a Platinum-Containing Doublet in Chemotherapy-Naive Subjects With Stage IV Adenocarcinoma of the Lung (FLAIR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Morphotek · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adenocarcinoma of the Lung

Interventions

Type	Name	Description
BIOLOGICAL	Farletuzumab	Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles. Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
OTHER	Placebo	Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles. Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.
DRUG	Carboplatin	Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL\^min \[AUC5-6\].
DRUG	Paclitaxel	Paclitaxel 200 mg/m\^2 will be administered intravenously.
DRUG	Pemetrexed	Pemetrexed 500 mg/m\^2 will be administered intravenously.
DRUG	Cisplatin	Cisplatin 75 mg/m\^2 will be administered intravenously.

Timeline

• Start date: 2011-06-27
• Primary completion: 2012-12-15
• Completion: 2013-11-01
• First posted: 2010-10-11
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

93 sites across 8 countries: United States, Australia, Canada, Germany, Italy, Poland, Russia, Spain