A Phase 3 Study of Atezolizumab in Patients With Non-Small Cell Lung Cancer

A Randomized Phase 3 Study of Atezolizumab (an Engineered Anti-PDL1 Antibody) Compared to Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222480

Enrollment

1100

Registered

2014-05-07

Start date

2014-05-20

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: Locally advanced or metastatic (Stage 3B, Stage 4, or recurrent) non-small cell lung cancer (NSCLC) Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen Measurable disease, as defined by RECIST v1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

Exclusion criteria: Known active or untreated central nervous system (CNS) metastases Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome History of autoimmune disease History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. Active hepatitis B or hepatitis C Prior treatment with docetaxel Prior treatment with CD137 agonists, anti CTLA4, 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
efficacy safety Observation / Inspection RECIST version1.1	—

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