EUCTR2013-000738-36-DEActive, not recruitingNot Applicable
A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety OF ABP 215 Compared with Bevacizumab in Subjects with Advanced Non-Small Cell Lung Cancer - Not Applicable
Amgen Inc.0 sites620 target enrollmentStarted: July 29, 2013Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 620
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Males and females = 18 and < 80 years of age
- •Histologically or cytologically confirmed non-squamous non-small cell lung cancer
- •Stage 4 or recurrent metastatic NSCLC with measurable disease according to modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1). For subjects with recurrent disease, at least 12 months must have elapsed since completing adjuvant chemotherapy. Subjects must have had a baseline scan (computed tomography [CT] or magnetic resonance imaging [MRI]) of the chest and abdomen to assess disease burden before enrolling in study and receiving first-line chemotherapy for NSCLC. If the scan was performed more than 28 days prior to randomization, an additional scan must be obtained
- •Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
- •ECOG performance status score 0 or 1
- •Normal bone marrow function as defined by:
- •absolute neutrophil count (ANC) = 1.5 x 109 g/dL (1,500/µL)
- •platelets = 100 x 109 g/dL (100,000/µL)
- •hemoglobin = 100 g/L (10.0 g/dL)
- •Adequate hepatic function as defined by:
- •total bilirubin < 1.5 × the upper limit of normal (ULN)
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT); < 3.0 × ULN;
- •Adequate renal function as defined by creatinine < 1.5 × ULN
- •Subjects must sign an IRB/EC-approved informed consent form before any study specific 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 435
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 185
Exclusion Criteria
- •Small cell lung cancer (SCLC) or mixed SCLC and NSCLC
- •Mixed adenosquamous carcinomas with a predominantly squamous component
- •Central nervous system (CNS) metastases
- •Tumor invading or compressing major blood vessels or tumor cavitation
- •Malignancy other than NSCLC
- •Palliative radiotherapy for bone lesions inside the thorax
- •Prior radiotherapy of bone marrow
- •Minor surgical procedure or core biopsy before randomization, or not yet recovered from prior minor surgery
- •Major surgery within 4 weeks before randomization or not yet recovered from prior surgery
- •Planned major surgical procedure during the treatment phase
- •Any of the following before randomization:
- •·Within 6 months: clinically significant cardiovascular disease; peripheral vascular disease, cerebrovascular accident or transient ischemic attack
- •·Within 3 months: history of hemoptysis
- •·At any time: history of thrombotic or hemorrhagic disorders
- •Proteinuria (with a urine dipstick value of 2+ or above or >100 mg/dL)
- •Coagulation abnormalities or systemic anticoagulation or chronic aspirin therapy. Subjects may receive low dose anti-coagulation therapy for peripheral port patency.
- •Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg
- •Any serious, non-healing wound or bone fracture
- •Clinically significant peripheral neuropathy
- •Significant unplanned weight loss attributed to cancer during previous 6 months.
- •Any known co-morbid disease that would increase the risk of toxicity
- •Known to be positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- •Recent infection requiring a course of systemic anti-infectives
- •Life expectancy < 6 months
- •Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
- •Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment
- •Other investigational procedures while participating in this study
- •Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
- •Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
- •Subject has previously been randomized in this study
- •Subject likely to not be available to complete all protocol required study visits or procedures
- •History or evidence of any other clinically significant disorder, condition
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