Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 10/21/2017 |
Start Date: | November 11, 2013 |
End Date: | July 23, 2015 |
A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer
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.
against bevacizumab in men and women with advanced non-small cell lung cancer.
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
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2
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