A Phase 2 Study of Atezolizumab in Patients With PD-L1 Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

A PHASE II, MULTICENTER, SINGLE-ARM STUDY OF ATEZOLIZUMAB IN PATIENTS WITH PD-L1-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222545

Enrollment

635

Registered

2014-06-26

Start date

2014-08-21

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: Adult patients, >/= 18 years of age Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) non-small cell lung cancer (NSCLC) Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens PD-L1-positive tumor status as determined by an IHC assay performed by a central laboratory Measurable disease, as defined by RECIST v1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Exclusion criteria: Any approved anti cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment Central nervous system (CNS) disease, including treated brain metastases. Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with negligible risk of metastases or death and treated with expected curative outcome History of autoimmune disease History of idiopathic pulmonary fibrosis (including pneumonia), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening CT scan. History of radiation pneumonitis in the radiation field (fibrosis) id permitted. Active hepatitis B or hepatitis C HIV positive Prior treatment with CD137 agonists, anti PD 1, or anti PD L1 therapeutic antibody or pathway-targeting agents

Design outcomes

Primary

Measure	Time frame
efficacy RECIST version1.1	—

Secondary

Measure	Time frame
safety efficacy Observation / Inspection RECIST version1.1	—

Countries

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

Outcome results

None listed

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