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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Farletuzumab; Paclitaxel; Pemetrexed

Criteria

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)