A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.

Inclusion Criteria:

• Histologically or cytologically confirmed non-squamous NSCLC.
• Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
• Other inclusion criteria may apply.

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.
• Active hepatitis B.
• Active hepatitis C.
• Tested positive for human immunodeficiency virus (HIV).
• Life expectancy < 6 months.
• Woman of childbearing potential who is pregnant or is breast feeding.
• Woman of childbearing potential 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.
• Other exclusion criteria may apply.