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)
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.
Progression-free Survival (PFS)
Overall Response Rate (ORR)
Adenocarcinoma of the Lung
Study Arms / Comparison Groups
Farletuzumab plus Chemotherapy
Description: During Combination Therapy, farletuzumab will be given with a protocol-approved platinum doublet (either carboplatin/paclitaxel, carboplatin/pemetrexed, or cisplatin/pemetrexed) for at least 4, but not more than 6, cycles. Participants who experience clinical benefit from the Combination Therapy will enter the Monotherapy Phase and receive farletuzumab as monotherapy until disease progression.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
June 27, 2011
November 1, 2013
Primary Completion Date
December 15, 2012
Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV - Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC) - Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo) - Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung Exclusion Criteria: - Participants who have had previous chemotherapy for adenocarcinoma of the lung - Prior surgery with curative intent for adenocarcinoma of the lung - Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control [i.e., palliative radiation with non-curative intent] is permitted)
18 Years - N/A
Accepts Healthy Volunteers