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A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer [IMpower133]

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Carboplatin plus Etoposide with or without Atezolizumab (Anti-PD-L1 Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223248
Enrollment
400
Registered
2016-06-22
Start date
2016-08-31
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

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

Sponsors

CHUGAI PHARMACEUTICAL CO., LTD.
Lead Sponsor
F. Hoffmann-La Roche Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Histologically or cytologically confirmed ES-SCLC -No prior treatment for ES-SCLC -ECOG performance status of 0 or 1 -Measurable disease, as defined by RECIST v1.1 -Adequate hematologic and end organ function

Exclusion criteria

Exclusion criteria: -Active or untreated CNS metastases -Malignancies other than SCLC within the last 5 years -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 CT scan. -Positive test for Human Immunodeficiency Virus (HIV) -Active hepatitis B or hepatitis C -Severe infections at the time of enrollment -Significant cardiovascular disease -Prior treatment with cluster of CD137 agonists or immune checkpoint blockade therapies, anti-PD1, and anti-PD-L1 therapeutic antibody

Design outcomes

Primary

MeasureTime frame
efficacy Obserbation, RECIST v1.1

Secondary

MeasureTime frame
efficacy pharmacokinetics safety Obserbation, RECIST v1.1

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