Advanced Non-small Cell Lung Cancer MedDRA version: 17.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ABP 215
Product Code: ABP 215
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Not Applicable
CAS Number: 1438851-35-4
Current Sponsor code: ABP 215
Other descriptive name
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 185
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ABP 215 with bevacizumab.;Secondary Objective: To assess the safety and immunogenicity of ABP 215 compared with bevacizumab.;Primary end point(s): Risk ratio of the incidence of overall response rate (ORR) ;Timepoint(s) of evaluation of this end point: ORR is assessed every 6 weeks. The actual endpoint is best response seen during the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Risk difference of ORR •Duration of response (DOR) •Progression-free survival (PFS) Safety Criteria: •Treatment-emergent adverse events •Treatment-emergent serious adverse events •Incidence of anti-drug antibodies •Overall survival (OS) ;Timepoint(s) of evaluation of this end point: Assessed at the end of the study | — |
Countries
Australia, Belgium, Bulgaria, Canada, Czech Republic, Germany, Greece, Hong Kong, Hungary, Italy, Mexico, Netherlands, Poland, Romania, Russian Federation, Singapore, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed