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