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

20180085

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).

2021-05-15

2022-11-13

2022-11-13

Withdrawn

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-07-03