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

• Conditions: Advanced Non-small Cell Lung Cancer; MedDRA version: 16.0Level: 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-ES
• Lead Sponsor: Amgen Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 31 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Males and females ? 18 and < 80 years of age
2. Histologically or cytologically confirmed non-squamous non-small cell lung cancer
3. 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
4. Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
5. ECOG performance status score 0 or 1
6. Normal bone marrow function as defined by:
. ? absolute neutrophil count (ANC) ? 1.5 x 109 g/dL (1,500/?L)
. ? platelets ? 100 x 109 g/dL (100,000/?L)
. ?hemoglobin ? 100 g/L (10.0 g/dL)
7. Adequate hepatic function as defined by:
. < total bilirubin < 1.5 × the upper limit of normal (ULN)
. 8. Adequate renal function as defined by creatinine < 1.5 × ULN
9. 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

1. Small cell lung cancer (SCLC) or mixed SCLC and NSCLC

2. Mixed adenosquamous carcinomas with a predominantly squamous component

3. Central nervous system (CNS) metastases

4. Tumor invading or compressing major blood vessels or tumor cavitation

5. Malignancy other than NSCLC

6. Palliative radiotherapy for bone lesions inside the thorax

7. Prior radiotherapy of bone marrow

8. Minor surgical procedure or core biopsy before randomization, or not yet recovered from prior minor surgery

9. Major surgery within 4 weeks before randomization or not yet recovered from prior surgery

10. 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

12. Proteinuria

13 Coagulation abnormalities or systemic anticoagulation or chronic aspirin therapy

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

15. Any unhealed wound or bone fracture

16. Clinically significant peripheral neuropathy

17. Significant weight loss

18. Any known co-morbid disease that would increase the risk of toxicity

19. Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)

20. Recent infection requiring a course of systemic anti-infectives

21. Life expectancy < 6 months

22. 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

23. 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

25. Other investigational procedures while participating in this study

26. 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)

27. Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products

28. Subject has previously been randomized in this study

29. Subject likely to not be available to complete all protocol required study visits or procedures

30. History or evidence of any other clinically significant disorder, condition

Study & Design

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