A Phase III Study of Atezolizumab in Combination With Carboplatin + Paclitaxel With or Without Bevacizumab in Patients With Stage IV Non-squamous Non-small Cell Lung Cancer

A PHASE III, OPEN-LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (MPDL3280A, ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH CARBOPLATIN+PACLITAXEL WITH OR WITHOUT BEVACIZUMAB COMPARED WITH CARBOPLATIN+PACLITAXEL+BEVACIZUMAB IN CHEMOTHERAPY NAIVE PATIENTS WITH STAGE IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222890

Enrollment

1202

Registered

2015-06-24

Start date

2015-09-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small Cell Lung Cancer

Interventions

investigational material(s) Generic name etc : Atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 18 years or older - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Histologically or cytologically confirmed, treatment-naive Stage IV non-squamous NSCLC - Previously obtained archival tumor tissue or tissue obtained from biopsy at screening - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and end organ function

Exclusion criteria

Exclusion criteria: - Active or untreated central nervous system (CNS) metastasis - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest Computed Tomography (CT) scan, History of radiation pneumonitis in the radiation field (fibrosis) is permitted - Positive test for Human Immunodeficiency Virus (HIV) - Active hepatitis B or hepatitis C - Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti PD-1, and anti-PD-L1 therapeutic antibody - Severe infection within 4 weeks prior to randomization - Significant history of cardiovascular diseas

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Progression-free survival (RECIST v1.1), overall survival	—

Secondary

Measure	Time frame
safety efficacy confirmatory pharmacokinetics Objective response rate, etc.	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026