Treatment of Adults with Advanced, Untreated, Non-Small Cell Lung Cancer With Either MEDI-575 or MEDI-575 Plus Carboplatin and Paclitaxel

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 112

Inclusion Criteria

Subjects must meet all the following criteria:
Age 18 years or older at the time of screening,
Written informed consent and any locally required authorization,
Histologically confirmed inoperable Stage IIIB or Stage IV non-small cell lung cancer
ECOG performance status of 0 or 1,
Life expectancy of = 3 months,
Prothrombin time elevation = Grade 2 is acceptable for subjects on anticoagulant therapy,
Adequate hematologic and organ function,
Suitable candidates for therapy with carboplatin/paclitaxel,
Subjects must have at least 1 lesion that is measurable using RECIST,
Subjects must be willing to consent to allow collection of archived NSCLC tumor samples,
Adequate contraception from screening through end of trial

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

Any of the following would exclude the subject from participation in the study:
Concurrent enrollment in another clinical study,
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals,
Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for treatment of cancer,
Previous monoclonal antibody treatment,
History of serious allergy or reaction to any component of the MEDI-575 formulation,
Receipt of any previous anticancer therapies,
(Previous adjuvant/neoadjuvant radiotherapy or chemotherapy is allowed)
New York Heart Association = Class II congestive heart failure,
History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to enrollment,
History of other invasive malignancy within 5 years,
Use of immunosuppressive medication within 7 days prior to enrollment,
Systemic immunosuppressive steroid therapy,
History of active human immunodeficiency virus (HIV) or active hepatitis virus infection (HBV, HCV),
Known brain metastases,
Clinically significant abnormality on ECG

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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