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

Completed · Phase 2 · Has a placebo group

Conditions studied: Adenocarcinoma of the Lung

In brief

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.

Key facts

Study ID

NCT01218516

Run by

Morphotek

People needed

130

Starts

2011-06-27

Expected to finish

2013-11-01

Last updated by the study team

2020-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Arizona Center for Hematology Oncology — Glendale, Arizona, United States
• Providence Health System — Beverly Hills, California, United States
• Cancer Care Associates of Fresno Medical Group, Inc. — Fresno, California, United States
• Medical Oncology Hematology — Gilroy, California, United States
• California Cancer Care, Inc. — Greenbrae, California, United States
• Moores University of California San Diego Cancer Center — La Jolla, California, United States
• Wilshire Medical Oncology Group — La Verne, California, United States
• Glendale Adventist Medical Center — Los Angeles, California, United States
• Clinical Trials and Research Associates, Inc. — Montebello, California, United States
• North Country Oncology-Hematology — Oceanside, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Central Coast Medical Oncology — Santa Maria, California, United States
• Rocky Mountain Cancer Centers, LLP — Denver, Colorado, United States
• Hematology Oncology Associates, P.C. — Stamford, Connecticut, United States
• Center for Hematology-Oncology — Boca Raton, Florida, United States
• Medical Specialists of the Palm Beaches — Deerfield Beach, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• Cancer Care of North Florida — Lake City, Florida, United States
• Florida Cancer Institute-New Hope — New Port Richey, Florida, United States
• Ocala Oncology Center, PL — Ocala, Florida, United States
• MD Anderson Cancer Center-Orlando — Orlando, Florida, United States
• University Hematology Oncology, Inc. — Centralia, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• Ironwood Cancer and Research Center — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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