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

Amgen

Status and phase: Completed; Phase 3

Conditions: Non-small Cell Lung Cancer Metastatic

Treatments: Drug: ABP 215; Drug: Paclitaxel; Drug: Carboplatin; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01966003

2013-000738-36 (EudraCT Number)

20120265

Details and patient eligibility

About

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.

Enrollment: 642 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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642 participants in 2 patient groups

ABP 215

Experimental group

Description:

Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Treatment:

Drug: ABP 215

Drug: Carboplatin

Drug: Paclitaxel

Bevacizumab

Active Comparator group

Description:

Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Treatment:

Drug: Bevacizumab

Drug: Carboplatin

Drug: Paclitaxel