A Randomized, Double-Blind, Placebo-Controlled, Study of the Safety and Efficacy of Farletuzumab in combination with Carboplatin and Paclitaxel or Docetaxel Followed by Pemetrexed in Chemotherapy na?ve Subjects with Stage IV Adenocarcinoma of the Lung with Wild Type EGFR - MORAb-003-009

Conditions: Stage IV adenocarcinoma of the lung
MedDRA version: 9.1Level: LLTClassification code 10025038

Registration Number: EUCTR2010-022229-13-IT

Lead Sponsor: MORPHOTEK INC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 165

Inclusion Criteria

[1] Female or male and =18 years of age [2] Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV [3] Wild-type EGFR [4] Adenocarcinoma of the lung must have confirmation of folate receptor-alpha (FRA) expression in =5% of tumor cells by immunohistochemistry [5] 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) [6] Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung [7] ECOG performance status (0 or 1) [8] Life expectancy of =3 months as estimated by the investigator [9] Adequate bone marrow reserve and organ function including calculated creatinine clearance =60 mL/min based on the standard Cockcroft-Gault equation [10] Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to the first dose of farletuzumab or placebo [11] Laboratory and clinical results within 14 days prior to Day 1 must be as follows: Absolute neutrophil count = 1.5 x 10^9/L; Platelet count = 100 x 10^9/L Hemoglobin =9 g/dL; Serum bilirubin = 1.5 x ULN; AST/ALT/ALK-P = 2.0 x ULN; Serum creatinine =2.0 mg/ dL [12] Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period (Contraceptive measures must start either prior to or at screening and continue throughout the entire study period and for 2 months after the last dose of study drug is administered; Pregnant and/or lactating females are excluded) [13] Subject must provide written informed consent and must be able to comply with the protocol procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[1] Subjects who have had previous chemotherapy for adenocarcinoma of the lung [2] Prior surgery with curative intent for adenocarcinoma of the lung XML File Identifier : 5lWStsxaE99yG+Xao+NN2C/Lvms= [3] 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) [4] EGFR mutation (exon 19 deletion and exon 21 activating mutation L858R) by IHC as assessed by the central laboratory or by PCR assessed by the investigative site [5] Clinically significant cardiovascular disease, congestive heart failure (New York Heart Association Class 3 or 4), clinically significant ventricular arrhythmia requiring medication, or unstable angina within 6 months of study enrolment [6] ECG demonstrating clinically significant arrhythmias (Note: subjects with chronic atrial arrhythmia, i.e. atrial fibrillation or paroxysmal supraventricular tachycardia [SVT] are eligible) [7] Peripheral neuropathy = NCI CTCAE v 3.0 Grade 2 [8] Known untreated brain metastases (Subjects with previously treated, stable brain metastases are allowed. Per investigator’s discretion subject must have fully recovered from radiotherapy or surgery (minimum of 14 days) prior to study entry; steroid or other anti-convulsant treatment must be completed 14 days prior to study entry) [9] Unable or unwilling to take folic acid, vitamin B12, or corticosteroids [10] Concurrent immunotherapy (i.e., immunosuppressants or chronic use of systemic steroids with the exception of low-dose corticosteroids) [11] Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA [12] Previous treatment with farletuzumab [13] Active serious systemic disease, including active bacterial or fungal infection [14] Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, psychiatric illness, or social situations that would limit compliance with study requirements [15] Known active human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C infection (Asymptomatic positive serology is not exclusionary) [16] Evidence of other active invasive malignancy requiring treatment in the past 5 years [17] Prior treatment with any investigational agent within 4 weeks of study entry [18] Breast-feeding, pregnant, or likely to become pregnant during the study