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

• Status: Withdrawn
• Trial end date: 2022-11-13
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Parexel
• Treatments: Bevacizumab; Carboplatin; Paclitaxel

Criteria

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.