A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer

MedImmune, LLC0 个研究点目标入组 112 人开始时间: 2012年3月30日最近更新: 2014年10月7日

试验速览

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•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

•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

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