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

Completed · Phase 3

Conditions studied: Non-small Cell Lung Cancer Metastatic

In brief

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.

Key facts

Study ID

NCT01966003

Run by

Amgen

People needed

642

Starts

2013-11-11

Expected to finish

2015-07-23

Last updated by the study team

2017-10-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Bismarck, North Dakota, United States
• Research Site — Fremantle, Western Australia, Australia
• Research Site — Veliko Tarnovo, Veliko Tarnovo, Bulgaria
• Research Site — Rousse, Bulgaria

Full record on ClinicalTrials.gov

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