Expired Study
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Beverly Hills, California 90210


Purpose:

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 chemotherapynaive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.


Criteria:

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV - Confirmed folate receptor-alpha (FRA) expression by IHC - Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by CT or 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: - Subjects 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)


NCT ID:

NCT01218516


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Beverly Hills, California 90210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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