The trial is designed to determine the efficacy and safety of ABP 215 compared with Bevacizumab in subjects with advanced non-small cell lung cancer

Phase 1

• Conditions: Advanced Non-small Cell Lung Cancer; MedDRA version: 14.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000738-36-IT
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-31
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 620

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:
·clinically significant cardiovascular disease; peripheral vascular disease, cerebrovascular accident or transient ischemic attack
·history of hemoptysis
·history of thrombotic or hemorrhagic disorders

Proteinuria

Coagulation abnormalities or systemic anticoagulation or chronic aspirin therapy

Medically uncontrolled hypertension or systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg

Any unhealed wound or bone fracture

Clinically significant peripheral neuropathy

Significant weight loss

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified