A Comparative Study of atezolizumab(MPDL3280A)With standard chemotherapy in Patients With Stage IV NSCLC

A PHASE III, OPEN LABEL, RANDOMIZED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH A PLATINUM AGENT (CISPLATIN OR CARBOPLATIN) IN COMBINATION WITH EITHER PEMETREXED OR GEMCITABINE FOR PD-L1-SELECTED, CHEMOTHERAPY-NAIVE PATIENTS WITH STAGE IV NON-SQUAMOUS OR SQUAMOUS NON-SMALL CELL LUNG CANCER

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222849

Enrollment

555

Registered

2015-05-18

Start date

2015-07-21

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: -Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC without any prior treatment -Tumor PD-L1 expression as determined by immunohistochemistry (IHC) assay of archival tumor tissue or tissue obtained at screening -Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 -Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) -Adequate hematologic and end-organ function

Exclusion criteria

Exclusion criteria: -Known sensitizing mutation in the EGFR gene or ALK fusion oncogene -Active or untreated central nervous system (CNS) metastases as determined by computed tomorgaphy (CT) or magnetic resonance imaging (MRI) evaluation -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 PD1, and anti-PD-L1 therapeutic antibody -Severe infection within 4 weeks prior to randomization -Significant history of cardiovascular disease

Design outcomes

Primary

Measure	Time frame
efficacy RECIST v1.1, observation	—

Secondary

Measure	Time frame
efficacy pharmacokinetics other safety RECIST v1.1, observation, lab test, PRO	—

Countries

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

Outcome results

None listed

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