Overview

Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

Status:
Completed
Trial end date:
2015-07-23
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Amgen
Collaborator:
Actavis Inc.
Treatments:
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Paclitaxel
Criteria
Inclusion Criteria:

- Histologically or cytologically confirmed non-squamous non-small cell lung cancer
(NSCLC)

- Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8
days after randomization and expected to receive at least 4 cycles of chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

Exclusion Criteria:

- Small cell lung cancer (SCLC) or mixed SCLC and NSCLC

- Central nervous system (CNS) metastases

- Malignancy other than NSCLC

- Palliative radiotherapy for bone lesions inside the thorax

- Prior radiotherapy of bone marrow

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

- 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

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

- Other inclusion/exclusion criteria may apply